ANI Pharmaceuticals recalls
FDA enforcement reports naming ANI Pharmaceuticals, Inc. as the recalling firm.
- Recall reports
- 13
- Class I (serious)
- 0
- Most recent report
- Jul 1, 2026
- Jul 1, 2026hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Dis…Drug · ANI Pharmaceuticals, Inc.Presence of foreign substanceClass III
- May 27, 2026Estradiol Gel, 0Drug · ANI Pharmaceuticals, Inc.Defective Container; packets were found to be either empty or partially full.Class II
- Feb 23, 2022Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by: ULTRAtab…Drug · ANI Pharmaceuticals, Inc.cGMP DeviationsClass II
- Feb 23, 2022Alprazolam Tablets, USP 2Drug · ANI Pharmaceuticals, Inc.cGMP DeviationsClass II
- Feb 23, 2022Alprazolam Tablets, USP 0Drug · ANI Pharmaceuticals, Inc.cGMP DeviationsClass II
- Feb 23, 2022Alprazolam Tablets, USP 0Drug · ANI Pharmaceuticals, Inc.cGMP DeviationsClass II
- Feb 23, 2022Alprazolam Tablets, USP 1Drug · ANI Pharmaceuticals, Inc.cGMP DeviationsClass II
- Oct 28, 2020Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulf…Drug · ANI Pharmaceuticals, Inc.Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.Class III
- Oct 28, 2020Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulf…Drug · ANI Pharmaceuticals, Inc.Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.Class III
- Oct 28, 2020Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulf…Drug · ANI Pharmaceuticals, Inc.Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.Class III
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulf…
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulf…
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulf…
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