FDAHealthJune 2, 2026
ANI Pharmaceuticals, Inc. — 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
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 2, 2026
Nationwide in the USA
What's affected?
- Product
- 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
- UPC
- 0370954912101
- Lot code
- 25133A
Additional details
Lot S25133A
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 6564 bottles.
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