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ANI Pharmaceuticals Recalls
13 recalls on record · October 28, 2020 to July 1, 2026 · Drugs
Recalls by year
20
22
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 1, 2026DrugsFDA
ANI Pharmaceuticals, Inc. recalls hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals,
Hazard: Presence of foreign substance
May 27, 2026DrugsFDA
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, In
Hazard: Defective Container; packets were found to be either empty or partially full.
February 23, 2022DrugsFDA
ANI Pharmaceuticals, Inc. recalls Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by: ULTRAtab Laboratories, Inc. Highland, NY
Hazard: cGMP Deviations
February 23, 2022DrugsFDA
ANI Pharmaceuticals, Inc. recalls Alprazolam Tablets, USP 2.0 mg, packaged in a) 100-count bottles (NDC 67253-903-10), b) 500-count bottles (NDC 67253-903
Hazard: cGMP Deviations
February 23, 2022DrugsFDA
ANI Pharmaceuticals, Inc. recalls Alprazolam Tablets, USP 1.0 mg, packaged in a) 100-count bottles (NDC 67253-902-10), b) 500-count bottles (NDC 67253-902
Hazard: cGMP Deviations
February 23, 2022DrugsFDA
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
Hazard: cGMP Deviations
February 23, 2022DrugsFDA
ANI Pharmaceuticals, Inc. recalls Alprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-900-10), b) 500-count bottles (NDC 67253-90
Hazard: cGMP Deviations
October 28, 2020DrugsFDA
ANI Pharmaceuticals, Inc. recalls Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixe
Hazard: Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
October 28, 2020DrugsFDA
ANI Pharmaceuticals, Inc. recalls Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixe
Hazard: Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
October 28, 2020DrugsFDA
ANI Pharmaceuticals, Inc. recalls Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixe
Hazard: Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
October 28, 2020DrugsFDA
ANI Pharmaceuticals, Inc. recalls Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixe
Hazard: Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
October 28, 2020DrugsFDA
ANI Pharmaceuticals, Inc. recalls Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixe
Hazard: Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
October 28, 2020DrugsFDA
ANI Pharmaceuticals, Inc. recalls Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixe
Hazard: Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.