Ani Pharmaceuticals recalls

Ani Pharmaceuticals appears in 13 official U.S. recall notices indexed by RecallRadar, most recently on 2026-07-01.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN…
  FDA Drug · Class III · 2026-07-01 · Ani Pharmaceuticals
• 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 56…
  FDA Drug · Class II · 2026-05-27 · Ani Pharmaceuticals
• 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, Dist…
  FDA Drug · Class II · 2022-02-23 · Ani Pharmaceuticals
• Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by: ULTRAtab Laboratories, Inc
  FDA Drug · Class II · 2022-02-23 · Ani Pharmaceuticals
• 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-…
  FDA Drug · Class II · 2022-02-23 · Ani Pharmaceuticals
• 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-c…
  FDA Drug · Class II · 2022-02-23 · Ani Pharmaceuticals
• 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-c…
  FDA Drug · Class II · 2022-02-23 · Ani Pharmaceuticals
• Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single…
  FDA Drug · Class III · 2020-10-28 · Ani Pharmaceuticals
• Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single…
  FDA Drug · Class III · 2020-10-28 · Ani Pharmaceuticals
• Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single…
  FDA Drug · Class III · 2020-10-28 · Ani Pharmaceuticals
• Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single…
  FDA Drug · Class III · 2020-10-28 · Ani Pharmaceuticals
• Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single…
  FDA Drug · Class III · 2020-10-28 · Ani Pharmaceuticals
• Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single…
  FDA Drug · Class III · 2020-10-28 · Ani Pharmaceuticals