ANI Pharmaceuticals recalls

3 official recalls and safety alerts involving ANI Pharmaceuticals since 2022-02, from FDA · Drug. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with ANI Pharmaceuticals or the relevant agency.

1. 2026-07-01
2. US
   Drugs & medicalClass III

   ANI Pharmaceuticals, Inc. recalls hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc.,…

   Presence of foreign substance

   FDA · DrugANI Pharmaceuticals, Inc.Nationwide in the USAOfficial notice →
3. 2026-05-27
4. US
   Drugs & medicalClass II

   ANI Pharmaceuticals, Inc. recalls Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette,…

   Defective Container; packets were found to be either empty or partially full.

   FDA · DrugANI Pharmaceuticals, Inc.Nationwide in the USAOfficial notice →
5. 2022-02-23
6. US
   Drugs & medicalClass II

   ANI Pharmaceuticals, Inc. recalls Alprazolam Tablets, USP 0.5 mg, packaged in a) 100-count bottles (NDC 67253-901-10), b) 500-count bottles (NDC 67253-901-50), and c)…

   cGMP Deviations

   FDA · DrugANI Pharmaceuticals, Inc.Nationwide within the United StatesOfficial notice →