ANI Pharmaceuticals, Inc. recalls hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals,
Recalled July 1, 2026 · FDA recall D-0619-2026 · ANI Pharmaceuticals
Hazard
Presence of foreign substance · FDA Class III
Units
6564 bottles
Sold at
Nationwide in the USA
Description
Presence of foreign substance
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
Manufacturer(s)
ANI Pharmaceuticals, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →