Ani Pharmaceuticals, Inc.: Hydroxyzine Hydrochloride Oral Solution, Usp, 10 Mg/5 Ml
Recall Summary ANI Pharmaceuticals is recalling hydroxyzine hydrochloride oral solution (10 mg/5 mL, 473 mL bottles) distributed nationwide because the product contains a foreign substance. This recall affects patients across all 50 states and Washington, DC who may have received this medication from pharmacies.
- Recalling firm
- ANI Pharmaceuticals, Inc.
- 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
- Reason
- Presence of foreign substance
- Classification
- Class III
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-06-02
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide in the USA
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/9de92c28-64e3-42da-8f61-9990fa7d3765