Filing Flows › ANI Pharmaceuticals (ANIP) › Recalls, complaints & regulation
ANI Pharmaceuticals (ANIP): recalls
ANI Pharmaceuticals (ANIP) beyond its filings: 2 recalls in the last 12 months (7 in five years, 0 Class I).
Latest recalls
- 2026-07-01 · FDA drug · hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC: 70954-9
- 2026-05-27 · FDA drug · Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-2
- 2022-02-23 · FDA drug · 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) 1000-count bottles (NDC 672
- 2022-02-23 · FDA drug · Alprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-900-10), b) 500-count bottles (NDC 67253-900-50), and c) 1000-count bottles (NDC 67
- 2022-02-23 · FDA drug · Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by: ULTRAtab Laboratories, Inc. Highland, NY 12528, Distributed by Par Pharmaceutical
- 2022-02-23 · FDA drug · Alprazolam Tablets, USP 2.0 mg, packaged in a) 100-count bottles (NDC 67253-903-10), b) 500-count bottles (NDC 67253-903-50), Rx only, Distributed by: Par Pharm
- 2022-02-23 · FDA drug · Alprazolam Tablets, USP 1.0 mg, packaged in a) 100-count bottles (NDC 67253-902-10), b) 500-count bottles (NDC 67253-902-50), and c) 1000-count bottles (NDC 672
ANI Pharmaceuticals' latest quarter
ANI Pharmaceuticals, Q3 2026: revenue $291M (+28% year over year), operating margin 18.0%, net earnings $35.1M, operating cash flow $83.8M. The chart follows the revenue to costs, profit and cash.
Questions
Has ANI Pharmaceuticals had any recalls?
7 recalls on file over five years from the FDA, CPSC and NHTSA; 2 in the last 12 months.
Updated Nov 8, 2026. Read automatically from SEC filings and public data; errors are possible. Not investment advice.