Official source
Verified ClaimWatch records sourced from U.S. Food and Drug Administration, including recalls, safety alerts, refunds, and consumer instructions.
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified...
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified...
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified...
Product(s) contain undeclared colors, FD&C Yellow #6 and FD&C Red #40 Product details: Bombay Kitchen brand Tikka Sev; Net Wt 9oz (255g); INGREDIENTS: Chickpea Flour, Water, Non-GMO...
Product contains dry milk powder ingredient recalled by the supplier due to potential Salmonella contamination Product details: Alfredo Sauce, 3 lb. 7 oz., packaged in a sealed poly bag...
Soy Lecithin listed in ingredients statement, but Soy is not mentioned in the contains statement. Product details: Zarlengo's Double Dark Chocolate Gelato packaged in 1 Gallon bucket/pail...
Soy Lecithin listed in ingredients statement, but Soy is not mentioned in the contains statement. Product details: Zarlengo's Chocolate Chocolate Chip Gelato packaged in multiple sizes (6...
Soy Lecithin listed in ingredients statement, but Soy is not mentioned in the contains statement. Product details: Zarlengo's Chocolate Gelato packaged in multiple sizes (6 fl oz cups, 16...
Presence of foreign substance: small metallic particles in chewable tablets. Product details: HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 1000 mg, 160-count bottle,...
Lack of Assurance of Sterility Product details: Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S....
Presence of foreign substance: small metallic particles in chewable tablets. Product details: HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY:...
Presence of foreign substance: small metallic particles in chewable tablets. Product details: CAREone, EXTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 750 mg, 96 chewable Tablets,...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). Product details: Marquesita de Chocolate y Vainilla [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). Product details: Rollitos de Guava [image] Guava Rolls The Original, Net Wt. 15 oz, packaged in a transparent and rigid plastic...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). Product details: Rollitos de DulceLeche [image] Caramel Rolls The Original, Net Wt. 15 oz, packaged in a transparent and rigid...
Product may be contaminated with Salmonella. Product details: 1. TNVitamins Ultrapotent Complete Green Superfood Moringa Capsules (120 count) 2. Doctor s Pride Complete Green Superfood...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). Product details: Cheesecake de Fresa [image] Strawberry Cheesecake The Original, Net Wt. 26 oz, packaged in a transparent and...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). Product details: Tiramisu [image] Cofee Cake The Original, Net Wt. 30 oz, packaged in a transparent and rigid plastic clamshell...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). Product details: Marquesita de Mango [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a transparent and...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). Product details: Cake de Fresa y Chocolate [image] Stawberry & Chocolate Cake The Original, Net Wt. 48 oz, packaged in a rigid...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). Product details: Cake de Mango [image] Mango Cake The Original, Net Wt. 47 oz, packaged in a rigid plastic clamshell container...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). Product details: Cheesecake de Guava [image] Guava Cheesecake The Original, Net Wt. 26 oz, packaged in a transparent and rigid...
Undeclared FD&C Red 40 Product details: ESTRELLA, Bebida de Parcha (Passion Fruit Drink), multiple sizes, 14 OZ.FL. (413 ML), 64 OZ.FL (1,920mL), 120 OZ.FL. (3.54LT.) 14 OZ.FL Plastic...
Potential physical contamination: dark spot was noticed on the bottom of container. Product details: MMB of Louisiana Pasteurized Donor Human Milk, Volume: 3 oz, Cal/Oz: 19, 0.9 g/dL...
Potential contamination with lead. Product details: DRAGONFLY Thai Ginger Powder Net Weight: 4.37 oz (125 g) PRODUCT OF THAILAND Packed for: U.S. Trading Company Hayward, CA 94545-1130...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). Product details: Napolitano [image] Neapolitan The Original, Net Wt. 22 oz, packaged in a transparent and rigid plastic clamshell...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). Product details: Cake de Capuchino [image] Capuchino Cake The Original, Net Wt. 63 oz, packaged in a transparent and rigid plastic...
May contain metal pieces Product details: Farm Rich Pizza Cheese Crunchers
Premature lipid oxidation causing quality issue potentially causing product to have an off odor and bitter taste. Product details: NEURO NOURISH dietary supplement; 6-IN-1 PREBIOTIC,...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). Product details: Cheesecake de Dulce de Leche [image] Caramel Cheesecake The Original, Net Wt. 26 oz, packaged in a transparent...
Imported Enoki Mushrooms tested positive for Listeria Monocytogenes. Product details: HH Fresh Trading Corp. (branded) ENOKI MUSHROOM; Premium Quality; Net WT/ Poids Net 150g(5.29oz)...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). Product details: Cake de Coco [image] Coconut Cake The Original, Net Wt. 47 oz, packaged in a rigid plastic clamshell container...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). Product details: Cheesecake de Mango [image] Mango Cheesecake The Original, Net Wt. 26 oz, packaged in a transparent and rigid...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). Product details: Jumbo Brazo Gitano Caramelo [image] Jumbo Caramel Roll The Original, Net Wt. 40 oz, packaged in a rigid plastic...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). Product details: Brazo Gitano [image] Caramel Sweet Roll The Original, Net Wt. 24 oz, packaged in a rigid plastic clamshell...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). Product details: Marquesita de Dulceleche [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a transparent...
The ingredient, Pista, currently declared on our label should be corrected to the standard American nomenclature, Pistachio. Product details: WeiKFiELD Custard Powder Kesar Pista, Net Wt....
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis Product details: Minocycline Hydrochloride...
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process. Product details: Gas-X Extra Strength, SIMETHICONE...
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution Product...
Microbial contamination of sterile products Product details: Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters, Made in USA, A Zep Inc. Brand, Distributed by:...
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Product details: Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules...
Failed Impurities/Degradations Specifications Product details: Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02...
Presence of Particulate matter: Particulate matter identified as glass. Product details: DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile,...
Microbial Contamination of Non-Sterile Products Product details: BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made with Propolis + Xylitol, 1 FL OZ (30 mL) per bottle,...
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Product details: Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx...
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer. Product details: Primidone Tablets, USP, 50...
Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint. Product...
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent. Product details: Brand Name: CGuard¿ Prime Carotid...
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock...
There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product...
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. Product details: Product Name: CORFLO* Safety PEG Kit with...
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. Product details: Product Name: MIC Safety Percutaneous...
The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays. Product details: Mahurkar Elite PASS Trays; Description (Product...
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. Product details: Product Name: MIC Safety Percutaneous...
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. Product details: Brand Name: CORFLO Product Name: CORFLO...
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent. Product details: Brand Name: CGuard¿ Prime Carotid...
Reusable electrodes may not meet expected performance levels. Product details: Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm) REF:...
Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label. Product details: NeoSpan¿ SuperElastic Compression Staple w/Instruments Catalog...
Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acquired from two or four different amplifiers used in a multiple amplifier configuration (128...
Sterile anchors my lack sterility assurance. Product details: Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Sesame Seeds White were labeled as Curry Powder Sweet. Product details: Lunds & Byerly's Curry Powder Sweet
Potential contamination with foreign objects (metal pieces). Product details: STRAUS FAMILY CREAMERY Cookie Dough ORGANIC SUPER PREMIUM ICE CREAM ONE PINT (473mL) Produced and Distributed...
Products may be potentially contaminated with Salmonella. Product details: White Cheddar Seasoning packaged in the following sized containers: 1. Net Wt. 1.2 oz (34g) Distributed by:...
Product contains dry milk powder ingredient recalled by the supplier due to potential Salmonella contamination Product details: Aramark Cheese Sauce New & Improved, 25 lb., packaged in a...
Potential contamination with foreign objects (metal pieces). Product details: STRAUS FAMILY CREAMERY Mint Chip ORGANIC SUPER PREMIUM ICE CREAM ONE PINT (473mL) Produced and Distributed by...
Products may be potentially contaminated with Salmonella. Product details: Karlsburger Kitchens Garlic N Cheese Topper, Net Wt: 20 oz. (567g). Distributed by: Karlsburger Foods, Inc.,...
Products may be potentially contaminated with Salmonella. Product details: #003020 Sour Cream & Onion, Net Wt: 10 lbs. JCB Flavors, 1224 Clark St. Watertown, WI 53094.
Undeclared allergen (sesame). Ingredients panel does not list sesame as sub-ingredient of Za'atar spice and Contains statement does not declare sesame. Product details: Market of Choice...
Product does not meet label claim for Vitamin E. Product details: Yunker(branded) Energy & Health Herbal Supplement with Vitamins; Manufactured by Sato Pharmaceuticals Co. Ltd.; 30ml...
Products may be potentially contaminated with Salmonella. Product details: #003740 Dill & Garlic Seasoning, Net Wt: 10 lbs. JCB Flavors, 1224 Clark St. Watertown, WI 53094.
Product contains dry milk powder ingredient recalled by the supplier due to potential Salmonella contamination Product details: 1) Cheese Sauce Mix, 25.5 oz., packaged in a sealed poly bag...
Products may potentially be contaminated with Salmonella. Product details: ANGEL branded STRAWBERRY SOFT-SERVE powder; 10- 2-pound bag/case NO UPC.
Salmonella. The firm was notified by the North Carolina Department of Agriculture that the product test positive for Salmonella. Product details: Malazi 100% PURE SUDANESE SESAME Tahina...
Product was manufactured and distributed without the benefit of an approved food establishment inspection and the required regulatory safety parameters could not be verified. Product...
Possible carbon steel foreign material (1-2mm) Product details: Betaine Anhydrous, 2055kg, material packed in foil bags inside 15kg cardboard box Label reads in part as "***BETAINE...
Potential contamination with foreign objects (metal pieces). Product details: STRAUS FAMILY CREAMERY Strawberry ORGANIC SUPER PREMIUM ICE CREAM ONE QUART (946mL) ONE PINT (473mL) Produced...
Un-eviscerated fish may be contaminated with clostridium botulinum Product details: Hellas Meze Golden Smoked Whole Herring
Products may be potentially contaminated with Salmonella. Product details: #0083004 Ranch Seasoning, Net Wt: 25 lbs. JCB Flavors, 1224 Clark St. Watertown, WI 53094.
Potential contamination with foreign objects (metal pieces). Product details: STRAUS FAMILY CREAMERY Vanilla Bean ORGANIC SUPER PREMIUM ICE CREAM ONE PINT (473mL) Produced and Distributed...
Products may be potentially contaminated with Salmonella. Product details: #007560 Fiery Hot Seasoning (Reduced Salt), Net Wt: 25 lbs. JCB Flavors, 1224 Clark Street, Watertown, WI 53094
The product may contain undeclared allergens (cashews, pistachios), and dried cherries. Product details: SECOND NATURE KETO CRUNCH SMART MIX, 10-ounce retail-sized plastic pouch, UPC...
Products may be potentially contaminated with Salmonella. Product details: #009530 Ranch Seasoning, Net Wt: 50 lbs. JCB Flavors, 1224 Clark Street, Watertown, WI 53094.
Products may be potentially contaminated with Salmonella. Product details: #800414/003729Butter Parsley, Net Wt: 50 lbs. JCB Flavors, 1224 Clark St. Watertown, WI 53094
Potential contamination with Salmonella Product details: 72% CACAO CHOCOLATE WITH DATE SUGAR WAFERS Ingredients: Cacao Beans, Organic Date Powder, Organic Cocoa Powder Net Wt 25lb (11.3kg)...
Presence of foreign substance: small metallic particles in chewable tablets. Product details: HyVee, Extra Strength Antacid, Calcium Carbonate 750 mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY:...
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan Product details: Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose...
Presence of foreign substance: small metallic particles in chewable tablets. Product details: TopCare health, ULTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 1000mg, 72 CHEWABLE...
Presence of foreign substance: small metallic particles in chewable tablets. Product details: GOODSENSE Ultra Strength, Antacid TABLETS, Calcium Carbonate 1000 mg, 72 Chewable Tablets,...
Presence of foreign substance: small metallic particles in chewable tablets. Product details: HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 750 mg, 330-count bottle,...
Presence of foreign substance: small metallic particles in chewable tablets. Product details: DISCOUNT drug mart, EXTRA STRENGTH, ANTACID TABLETS, Calcium Carbonate 750 mg, 96 Tablets,...
Presence of foreign substance: small metallic particles in chewable tablets. Product details: CAREone, ULTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 1000 mg, 72 chewable Tablets,...
Presence of foreign substance: small metallic particles in chewable tablets. Product details: EQUALINE ultra strength, antacid tablets, calcium carbonate 1000mg, 72 chewable tablets,...
Presence of foreign substance: small metallic particles in chewable tablets. Product details: GOODSENSE Extra Strength, Antacid TABLETS, Calcium Carbonate 750 mg, 96 Chewable Tablets,...
Presence of foreign substance: small metallic particles in chewable tablets. Product details: EQUALINE extra strength, antacid tablets, calcium carbonate 750mg, 96 chewable tablets,...
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona Product details: Xyvona...
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the...
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching...
These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has issued a voluntary recall due to potential...
Temperature probe devices lack FDA clearance. Product details: Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. Product details: Atlan...
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the...
Fingerprint scanner may overheat to a temperature to cause 1st degree burn. Product details: BD Pyxis MedBank Tower REF: 1145-00 Medication cabinet
Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer reports indicate that the stopcock cannot be...
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching...
Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the...
Fingerprint scanner may overheat to a temperature to cause 1st degree burn. Product details: BD Pyxis Mini Main REF: 349 Medication cabinet
The V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face. Product details: Arvis Hip & Knee 3.0 Instrument Set, REF:...
Product was made with milk powder recalled by the supplier due to Salmonella contamination. Product details: Ellsworth Sour Cream + Onion Seasoning, Part #: 180000113. Net Wt 25.00 lbs...
potential presence of Salmonella Product details: Good & Gather Mexican Street Corn Trail Mix 8 oz bag UPC 085239270240, 8 bags per case
Potential contamination with Salmonella. Product details: GHIRARDELLI SWEET GROUND POWDER WHITE CHOCOLATE FLAVORED NET WT 50oz (3lbs 2oz) 1.41kg Distributed by Ghirardelli Chocolate...
May be under-processed resulting in growth of Clostridium botulinum and lists health claims. Product details: Menopause Bully 16 oz and 32 oz.
potential to be contaminated with Salmonella Product details: Solina 6036195 Ranch Seasoning, 50lb bag
Product was made with milk powder recalled by the supplier due to Salmonella contamination. Product details: VG7274D1 Natural Cream of Mushroom Type Flavor, Net Weight: 50 lbs. bag. Item...
potential presence of Salmonella Product details: Fisher Tex Mex Trail Mix 30 oz plastic jar UPC 070690275941, 6 jars per case
Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns. Product details: Liposomal Sleep Spray. Dosage: 6...
potential to be contaminated with Salmonella Product details: Solina 6036443 Cheddar Cheese Powder Seasoning, 50lb bag
Product was made with milk powder recalled by the supplier due to Salmonella contamination. Product details: Blackstone Parmesan Ranch Seasoning, Net Wt 7.3 oz (207g). UPC 7 17604-04106 2....
Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns. Product details: Liposomal B12 Spray. Dosage: 3 sprays...
Potential contamination with Salmonella. Product details: GHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX FROZEN HOT COCOA NET WT 50oz (3lbs 2oz) 1.42kg Ingredients: *** nonfat dry milk ***...
potential to be contaminated with Salmonella Product details: Solina 6036087 Cr¿me Fraiche Spice Seasoning, 25lb bag
potential to be contaminated with Salmonella Product details: Solina 6036277 Garlic Cream Sauce Seasoning, 40lb bag
Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns. Product details: Liposomal Kids Liquid Multivitamin...
potential to be contaminated with Salmonella Product details: Solina 6036554 Parmesan Breadstick Sauce Seasoning, 40lb bag
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule. Product details: Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip,...
Subpotent Drug Product details: fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3650 Victorie St N, Suite 900,...
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit Product details: Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx...
Presence of particulate matter: a white thread-like structure in the cartridge Product details: Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin...
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit Product details: Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx...
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Product details: Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per...
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Product details: Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by:...
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Product details: Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by:...
Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus. Product details: MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%),...
Lack of Assurance of Sterility Product details: cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), Rx ONLY, Manufactured by: UCB Inc., Smyrna, GA 30080, a) NDC...
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Product details: Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per...
Defective Container; packets were found to be either empty or partially full. Product details: Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed...
Failed Impurities/Degradation Specifications Product details: Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals,...
It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may,...
Products were made with recalled California Dairies milk powder due to Salmonella. Product details: Butter Parsley Bagel Crisps, Item Number 18490, Net Weight: 10 lbs. Legacy Bakehouse,...
Undeclared Milk Allergen, Product details: Wawa Diet Iced Tea Lemon Pint (16oz),Plastic bottle
Undeclared Milk Allergen, Product details: Wawa Diet Lemonade Pint (16oz), Plastic bottle
Firm received and used potentially contaminated (Salmonella) ingredient to manufacture various products. Product details: (BULK) SPL-BEV Banana CWT (Banana Smoothie); Super Sack Tote Item#...
Products were made with recalled California Dairies milk powder due to Salmonella. Product details: giant eagle Baked Pita Chips with Parmesan, Garlic & Herb Bagel Crisps, Net Wt 7.33 oz....
Products were made with recalled California Dairies milk powder due to Salmonella. Product details: Parmesan & Herb Bagel Crisps, Item Number 18139, Net Weight: 10 lbs. Legacy Bakehouse,...
Undeclared Milk Allergen, Product details: Wawa Iced Tea Lemon 16 oz Pint, Plastic bottle
Undeclared Milk Allergen, Product details: Wawa Fruit Punch Pint (16oz), Plastic bottle
Possible cross-contamination resulting in undeclared allergen ingredient (Peanut) Product details: Fly By Jing (branded) Creamy Sesame Noodles; 3.8 oz packets. Sold in single and 4 packs....
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units. Product...
Failed Stability Specifications Product details: PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North...
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a...
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing...
Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC...
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a...
Specific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock Syringes, Tuberculin Print, Sterile. Cardinal Health has recalled these syringes because the outer carton and blister...
Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system. Product details: RelayPro...
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates. Product details: Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model...
Nitrile Exam Glove failed to meet specifications chemical permeation performance. Product details: Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772...
May be under-processed resulting in growth of Clostridium botulinum and lists health claims. Product details: Fibroid Bully 16 oz and 32 oz.
Seasoning was made with recalled California Dairies milk powder due to Salmonella contamination. Product details: Pork King Good Onion & Sour Cream Seasoning. Net Wt. 3 oz (85G) bottle....
Potential contamination with Salmonella. Product details: GHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX WHITE MOCHA NET WT 50oz (3lbs 2oz) 1.42kg Ingredients: *** nonfat dry milk ***...
May be under-processed resulting in growth of Clostridium botulinum and lists health claims. Product details: Prostate Bully 16 oz and 32 oz
May be under-processed resulting in growth of Clostridium botulinum and lists health claims. Product details: Blackseed Bitters 16 oz and 32 oz.
May be under-processed resulting in growth of Clostridium botulinum and lists health claims. Product details: Pure Shilajit Tonic 16 oz and 32 oz
Potential contamination with Salmonella. Product details: GHIRARDELLI SWEET GROUND POWDER CHOCOLATE & COCOA NET WT 48oz (3lbs) 1.36kg Distributed by Ghirardelli Chocolate Company, San...
Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns. Product details: Liposomal Mens 50+ Liquid...
potential to be contaminated with Salmonella Product details: Solina 6022487 Garlic Herb Topping, 50lb bag
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Product details: Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by:...
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling. Product details: Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by:...
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood...
Certain lots of product have the potential for a sterile barrier breach. Product details: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary...
Certain lots of product have the potential for a sterile barrier breach. Product details: Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T;...
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood...
Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control...
Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant with the inserter, which...
Due to stain present on the surface of affected foley catheters. Product details: Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic...
Affected devices exhibited fractures at the distal shaft tip without complete detachment. Product details: Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1)...
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may...
Undeclared Yellow #5 Product details: Banana Ice Cream - 32 oz (4 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods) UPC: 8-12017-00903
Undeclared Milk, Soy, Red #40. Product details: Loard's Peppermint Ice Cream - 32 oz; 56 oz
Potential contamination with Salmonella. Product details: Low Heat Non-Fat Dried Milk Powder - paper bags 25 kg. (packed under 5 labels: Off Grade NFDM Variable; Extra Grade NFDM Standard...
Multi-state outbreak of E. coli O157:H7. Product details: RAW FARM RAW CHEDDAR SIMPLY SHREDDED Original MADE WITH: WHOLE RAW MILK TRULY RAW - NEVER WARMED ABOVE 102F MADE IN THE USA KEEP...
Package integrity compromised. Product details: Horizon Organic Chocolate Organic Lowfat Milk. Saleable Unit UPC: 742365004322 (6-8 FL OZ Milk Boxes). Case: ORG MILK 1% DHA CHOCOLATE 3/6PK...
Potential contamination with foreign materials. Product details: LUNDBERG FAMILY FAMRS WHITE RICE JASMINE NET WT 32 OZ (2 lb) 907 g Manufactured and Distributed by: Lundberg Family Farms...
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic. Product details: Fain s Blackberry Honey Spread, 12oz net wt., UPC 01832213862
Undeclared Milk, Red #40. Product details: Loard's Champagne Sherbert - 32 oz
Potential contamination with Salmonella. Product details: Low Heat Non-Fat Dried Milk Powder - plastic totes (NTE) 2200 lbs. (packed under 5 labels: Off Grade NFDM Variable; Grade A NFDM...
Potential Salmonella contamination. The firm was notified from their supplier that the nonfat dry milk may be contaminated with Salmonella. Product details: Costco Service Deli Department...
Product has the potential to be contaminated with Salmonella. Product details: Bulk WN-976-782-1 Seasoning for Cheese Sauce, Net Wt. 43.50 lbs., in a brown kraft bag
Incorrect Product Formulation: product did not contain insulin as listed in the label. Product details: TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag, Rx...
Lack of assurance of Sterility: potential product contamination Product details: BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile...
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals. Product details:...
Chemical contamination; presence of lead and lithium above specification Product details: NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by:...
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test Product details: Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx...
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals. Product details:...
Subpotent drug Product details: busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201...
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit Product details: Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by...
Presence of Particulate Matter. Product details: Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07.
Lack of Assurance of Sterility: Potential leaks from perforations in bags. Product details: DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for...
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. Product details:...
Foreign object (stainless steel dust/flakes or shreds of plastic) Product details: Dakota Honey Company Spreadable Spun Honey, Salted Caramel. Stir before use. Produced in Winner, SD....
Product may contain foreign objects, specifically glass. Product details: Alain MILLIAT; MARMELADE ORANGE; 300 g 10.6 oz; packaged in glass jars
Contains undeclared allergens (cashews, milk, and soy). Product details: Uncle Giuseppe's Marketplace Milk Chocolate Bridge Mix, 11 oz Net Wt, packed in clear tamper resistant plastic...
Foreign object (stainless steel dust/flakes or shreds of plastic) Product details: Dakota Honey Company Spreadable Spun Honey, Jalapeno. Stir before use. Produced in Winner, SD. Packaged...
Salmonella Product details: Pure Ground Ingredients-Organic Peppermint Leaf Powder. wholesale bulk; tea/food manufacturers. Closed container stored in a cool settings at ambient/room...
Foreign object (stainless steel dust/flakes or shreds of plastic) Product details: Dakota Honey Company the Honey Flight. 4 Flavors of Spreadable Spun Honey Original - Salted Caramel -...
Contains undeclared Blue 1 Product details: Swad Mango Flavored Masala Candy
Undeclared allergens (wheat and soy). Product details: Frederik's by meijer Vanilla Bourbon Trail Mix, packed in plastic retail-sized black bag NET WT 9 OZ (255g). On the back of the bag...
Possible Salmonella in croutons. The firm was notified by their supplier that the non-fat milk powder used to manufacture the product was recalled due to possible salmonella. Product...
Products contain undeclared soy, specifically soy lecithin. Product details: Prospector Popcorn brand Belgian Chocolate Toffee flavored popcorn; Ingredients: Non-GMO popcorn, brown sugar,...
Foreign object (stainless steel dust/flakes or shreds of plastic) Product details: Dakota Honey Company Spreadable Spun Honey, Cinnamon-Infused. Stir before use. Produced in Winner, SD....
Contains undeclared FD&C Yellow 6 Product details: Swad Orange Flavored Masala Candy
Undeclared allergen ingredient (fish) Product details: ...And Kimchi branded kimchi; packaged in 3 sizes of glass containers (126oz, 63oz, 30oz); 126oz UPC- 8541200408 62oz UPC- 8651200409...
Foreign object (stainless steel dust/flakes or shreds of plastic) Product details: Dakota Honey Company Spreadable Spun Honey, Original. Stir before use. Produced in Winner, SD. Packaged...
Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision. Product details:...
Presence of particulate matter: identified as Buprenorphine free base Product details: Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured...
Failed Dissolution Specifications Product details: Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Laboratories Ltd.,...
Medline has identified the presence of particulate within the fluid path of the Manifolds. Product details: Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART...
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain...
Incomplete seals on sterile product Product details: BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to...
Due to broken connector which may result in a temporary interruption of prescribed cold therapy. Product details: Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog...
Incomplete seals on sterile product Product details: BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Complaints have been received of systems developing loose, missing, or broken internal bolts over time. Product details: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers:...
Potential for mislabeled syringe produced by the i.v.STATION device. Product details: Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE,...
Incomplete seals on sterile product Product details: Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain...
Medline has identified the presence of particulate within the fluid path of the Manifolds. Product details: Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107;...
Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to...
Incomplete seals on sterile product Product details: BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product Product details: Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer. Product details: Similasan, iVIZIA, Sterile...
Potential contamination with pesticides, haloxyfop and thiamethoxam Product details: SunRidge Farms Organic CHILI BEAN BLEND CERTIFIED ORGANIC BY QAI NET WT. 15 LBS Item: 003056 UPC:...
Undeclared Soy (with mitigating circumstances) Product details: Chocolate Showers Ice Cream - 32 oz (5 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods, and Berkeley...
Undeclared Milk, Wheat, Soy, Yellow #5, Green #3. Product details: Loard's Lime Sherbert - 32 oz
Undeclared Milk, Walnuts, Eggs, Wheat, Soy. Product details: Loard's Brownie Nut Fudge Ice Cream - 32 oz
Undeclared Red #40, Blue #1, Blue #2 Product details: Burgundy Cherry Ice Cream - 32 oz (4 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods) UPC: 8-12017-00909
Undeclared Milk, Eggs, Yellow #5. Product details: Loard's Lemon Chiffon Ice Cream - 32 oz
Undeclared Milk, Red #3, Red #40, Blue #1, Blue #2. Product details: Loard's Ube Ice Cream - 32 oz
The potential contamination with Clostridium botulinum, due to risk of temperature abuse during chilled storage at the firm Product details: Garland Fresh Peeled Garlic 6 oz. bag
Undeclared Red #40 Product details: Peppermint Ice Cream - 32 oz (4 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods) UPC: 8-12017-00933
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic. Product details: Natural Creamed Honey, 671333101377 *These product labels may...
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic. Product details: Lemon Creamed Honey, 671333101353 *These product labels may...
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic. Product details: Blackberry Creamed Honey 671333101308 * These product labels...
Undeclared Milk, Almonds, Soy, Sulfites. Product details: Loard's Almond Joy Ice Cream - 32 oz
Potential contamination with pesticides, haloxyfop and thiamethoxam Product details: SunRidge Farms Organic Black Beans CERTIFIED ORGANIC BY QAI NET WT. 25 LBS. ORIGEN: ARGENTINA...
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals. Product details:...
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging...
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. Product...
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging...
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging...
The devices were distributed without required FDA premarket clearance or approval. Product details: One Step K in vitro diagnostic test REF: 81A4
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging...
Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm. Product...
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging...
Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability...
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging...
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging...
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging...
Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection or full disconnection between the...
Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester). Product details: Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module...
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging...
Undeclared hazelnut and soy lecithin. Product details: Kirkland Signature Traditional Madeleines 12 Count/net wt. 18oz., Item #2000012, UPC 000020000127. Plastic clamshell container is...
Lead level was higher than NYSAGM Standard. Product details: Spice Powder, 4 oz, Plastic Bag
Product(s) contain undeclared colors, FD&C Yellow #6 and FD&C Red #40 Product details: Bombay Kitchen brand Punjabi Mix; Net Wt 9oz (255g); INGREDIENTS: Chickpea Flour, Water, Non-GMO...
Undeclared milk. Product details: Bulk Horchata Powder 3951 (100547) 1/25 HORCHATA UPC: 042743-19015-0 Item: 100547
Product may be contaminated with Salmonella. Product details: SALUTE SEASONINGS; Ground All Spice; Net Wt 16oz; Unistel Industries 650 Blossom Road Rochester, NY 14610; UPC: 7 69203 01617 0
Undeclared milk. Product details: EL MEXICANO agua fresca de horchata Instant Horchata Drink NET WT 12oz (340g) INGREDIENTS: *** MILK SUBSTITUTE (WHEY *** LACTOSE *** DISTRIBUTED BY...
Undeclared milk. Product details: EL MEXICANO horchata casera Instant Horchata Drink NET WT 14oz (396g) INGREDIENTS: *** MILK SUBSTITUTE (WHEY *** LACTOSE *** DISTRIBUTED BY MARQUEZ...
Hard corn starch lumps were found in the product Product details: CHIPS AHOY! Baked Bites Brookie .22.4 oz Carton ( 2.8 oz pouch ) and 7.7 oz Carton ( 1.4 oz pouch)
Ingredients statement declares Anchovy and Sasame, but Contains statement does not declare Fish (Anchovy) and Sesame. Product details: Booey's Dragon's Breath sauce, 15.2oz ringneck glass...
High sugar content. The firm was notified by the FDA that sample results were positive for a high C4 sugar content. Product details: Raw & Unfiltered Bee Well Wildflower Honey NET wT. 12...
mislabeled Coconut Date Bites. (product is coconut covered, label is for regular date bites) Product details: Label is predominantly green with white lettering in a clear plastic clamshell...
May be temperature abused, which may result in growth of Clostridium botulinum Product details: Crab Cakes various sizes sold to food service
Contains undeclared FD&C Yellow 6 Product details: Negita Cracker- Shrimp 2.8oz
Products contain unapproved colors, specifically tartrazine (FD&C Yellow 5), sunset yellow (FD&C Yellow 6), and allura red (FD&C Red 40). Product details: 52USA brand POPPING BOBA; PASSION...
Products contain unapproved colors, specifically tartrazine (FD&C Yellow 5), sunset yellow (FD&C Yellow 6), and allura red (FD&C Red 40). Product details: 52USA brand POPPING BOBA; MANGO...
Product may contain foreign objects, specifically glass. Product details: Specially SELECTED brand Vanilla Creme Brulee; NET WT 3.6oz (103g); INGREDIENTS: CREAM (MILK, CREAM), FROZEN YOLK...
Undeclared allergen (almond). Product details: Top Lid Label: Einstein Bros Bagels Honey Almond Double-Whipped Shmear. Cup Label: Plain Whipped Cream Cheese Spread. Net Wt 6 oz (170g). UPC...
Products contain unapproved colors, specifically tartrazine (FD&C Yellow 5), sunset yellow (FD&C Yellow 6), and allura red (FD&C Red 40). Product details: 52USA brand POPPING BOBA;...
Foreign object found inside retail container. Product details: My Mochi Strawberry flavored Non-Dairy Frozen Dessert; 7.5 oz; 6 pieces per container. UPC# 0-70934-99645-8
Product contains undeclared Yellow No. 5. Product details: Calypso Tropic Tango Lemonade. 16 FL oz (1PT) (473 ML). UPC 0 79581-18709 7. Keep Refrigerated After Opening. King Juice Company,...
Undeclared food colorings (Yellow 6, Blue 1, and Yellow 5) and unapproved Acid Red 14. Product details: KLG, Kesar Mukhwas, perishable, 24 months, flexible plastic, 200 gm, 818812022208,...
product tested positive for Listeria Monocytogenes. Product details: Black label with blue lettering. FOOD Korean Food, ENOKI MUSHROOM, 150g clear plastic package; Product of Korea, Keep...
cGMP deviations. Product details: Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31.
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer. Product details: iVIZIA, Sterile Lubricant...
cGMP deviations. Product details: fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65.
cGMP deviations. Product details: fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC...
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality. Product details: GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl...
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side. Product details: Alendronate Sodium Oral Solution, 70...
cGMP deviations. Product details: fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Houston, NDC 73702-202-02.
Lack of Assurance of Sterility Product details: Optase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile, Manufactured for Scope Health Inc., 79 Madison Ave., 8th...
cGMP deviations. Product details: fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC 73702-204-25.
Failed PH Specifications Product details: Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2%), NET WT 0.5 OZ (14 g), Distributed by: CVS PHarmacy, INc., One...
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality. Product details: Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35...
cGMP deviations. Product details: Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03
Labeling: Missing Label Product details: Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967....
cGMP deviations. Product details: fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15.
BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below...
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be...
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be...
It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufacturer-installed settings....
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel...
Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the...
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol...
Cyber vulnerability of BLE communication was found by CISA VDP program. Product details: WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor...
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol...
ventricular fibrillation (VF) during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or...
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel...
Label declares cream cheese but does not declare milk Product details: Riverence Smoked Trout Dip, net wt. 7oz. Product is perishable, refrigerated, packaged in plastic tub. Product is...
FDA analysis revealed the presence of undeclared sildenafil Product details: Blue Bull Extreme Male Enhancement Supplement, total of 15 pouches per box, Net Wt 15 G each pouch. Dosage:...
Products contain banned sweetener: cyclamates. Product details: DADI NONGFU DRIED SALT CHILLI VEGETABLE(S); Ingredients: Radish, chili, roasted sesame, prickly ash, edible salt, soybean...
FDA analysis revealed the presence of undeclared sildenafil Product details: Red Bull Extreme Male Enhancement Supplement, total of 15 pouches per box, Net Wt 15 G each pouch. Dosage:...
Products contain banned sweetener: cyclamates. Product details: Olive Skewers individually wrapped and packaged in clear plastic bag; 500g; INGREDIENTS: Olive, edible salt, white sugar,...
Potential Salmonella Contamination Product details: Fresh Cantaloupe (Whole, Fresh), brand name Ayco, wrapped in food safe plastic bags packed in corrugated cardboard cartons; 6-12 melons...
FDA analysis revealed the presence of undeclared sildenafil and Tadalafil Product details: Boner Bears Honey Male Enhancement 100% Wildflower Honey, total of 15 pouches per box, Net Wt 15...
Undeclared sesame. Sandwich contains visible sesame but label does not declare sesame. Product details: ReadyMeals Turkey Bacon & Cheddar Pretzel Duo Sandwich, perishable, Keep...
Contains undeclared egg, soy, and hazelnut Product details: Vital Nutrients Aller-C (vitamin C, citrus bioflavonoids, isoquercitrin, and bromelain)100 count bottles and 200 count bottles
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells. Product details: Omega-3-Acid, Ethyl Esters,...
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. Product details: DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B....
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit. Product details: Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by:...
Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that...
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. Product details: LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B....
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin Product details: Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count...
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. Product details: 0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only,...
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. Product details: Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy...
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots." Product details: Pantoprazole Sodium, Delayed-Release...
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. Product details: Fluocinonide, USP, 0.05% Cream,...
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on...
Chemical contamination: Presence of benzene Product details: FHF Farmhouse Fresh, Midnight Clearing, NIGHT LOTION, 2.5% BENZOYL PEROXIDE ACNE TREATMENT, OTC a) 0.5 fl. oz./15ml; and b)1...
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on...
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on...
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. Product details:...
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. Product details: Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model...
Unapproved design changes to the products outside of the 510(k) clearance. Product details: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU...
Potential for detachment of a distal tip component of the device during use. Product details: Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. Product details: Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ...
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. Product details:...
XXX Product details: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility. Product details: LSL Healthcare Wound Closure Tray,...
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. Product details: Medline Kits: 1) CATH LAB CDS, Model Number:...
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. Product details: Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model...
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. Product details:...
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility. Product details: LSL Healthcare, Foley Urine...