ANI Pharmaceuticals recalls
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for ANI Pharmaceuticals and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-07-01FDA-DrugClass IIIANI Pharmaceuticals hydroxyzine solution recalled for foreign substance
ANI Pharmaceuticals is recalling hydroxyzine hydrochloride oral solution (10 mg/5 mL, 473 mL bottles) due to the presence of a foreign substance in one lot. The affected product was distributed nationwide. No injuries have been reported.
- 2026-05-27FDA-DrugClass IIANI Pharmaceuticals estradiol gel recalled for defective packets
ANI Pharmaceuticals is recalling estradiol gel (0.1%, 0.25 mg packets) because some packets in affected cartons were found to be empty or only partially filled. This could mean patients receive less medication than prescribed. The recall affects carton lot M251109, which expires in November 2027.
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