ANI Pharmaceuticals, Inc. Provisional
FDA Flags (7)
Class III RecallJul 2026
ANI Pharmaceuticals, Inc.
hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals,
Classification: Class III
Class II RecallMay 2026
ANI Pharmaceuticals, Inc.
Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, In
Classification: Class II
Class II RecallFeb 2022
ANI Pharmaceuticals, Inc.
Alprazolam Tablets, USP 0.5 mg, packaged in a) 100-count bottles (NDC 67253-901-10), b) 500-count bottles (NDC 67253-901
Classification: Class II
Class II RecallFeb 2022
ANI Pharmaceuticals, Inc.
Alprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-900-10), b) 500-count bottles (NDC 67253-90
Classification: Class II
Class II RecallFeb 2022
ANI Pharmaceuticals, Inc.
Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by: ULTRAtab Laboratories, Inc. Highland, NY
Classification: Class II
Class II RecallFeb 2022
ANI Pharmaceuticals, Inc.
Alprazolam Tablets, USP 2.0 mg, packaged in a) 100-count bottles (NDC 67253-903-10), b) 500-count bottles (NDC 67253-903
Classification: Class II
Class II RecallFeb 2022
ANI Pharmaceuticals, Inc.
Alprazolam Tablets, USP 1.0 mg, packaged in a) 100-count bottles (NDC 67253-902-10), b) 500-count bottles (NDC 67253-902
Classification: Class II