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Recall

ANI Pharmaceuticals, Inc.: hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Recall

Presence of foreign substance Product details: hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC: 70954-912-10

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Verification

Official-source record

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Agency
FDA
Record ID
D-0619-2026
Canonical
https://claimwatch-mvp.vercel.app/item/ani-pharmaceuticals-inc-hydroxyzine-hydrochloride-oral-solution-usp-10-mg-5-ml-473-ml-1-pi/

What happened?

Presence of foreign substance Product details: hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC: 70954-912-10

Who may be affected?

Nationwide in the USA

What should consumers do?

Affected quantity: 6564 bottles

Official source

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FAQ

Is this page official?

No. ClaimWatch links to official sources and marks whether a page is verified or still being monitored.

Is this legal, medical, or financial advice?

No. This page is informational. Always confirm eligibility, deadlines, and safety instructions through official sources.

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