Official source
Verified ClaimWatch records sourced from U.S. Food and Drug Administration, including recalls, safety alerts, refunds, and consumer instructions.
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...
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...
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...
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...
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...