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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

Presence of foreign substance

Class III Medicine & devices FDA July 1, 2026 Reached Texas
Read the official FDA notice →

What to do

Stop using the product and check it against the description above. Follow the remedy on the official notice; most recalls are refunded or replaced without a receipt. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.

Details

Recalling company
ANI Pharmaceuticals, Inc. — Baudette, MN
Severity
Class III — low
Reported
July 1, 2026
Quantity
6564 bottles
Recall number
D-0619-2026
Status
Ongoing
Source
FDA

Where it went

Nationwide in the USA

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