Home / Recalls / ANI Pharmaceuticals, Inc. / D-0543-2026

D-0543-2026 Class II Ongoing

Recalled by ANI Pharmaceuticals, Inc. — Baudette, MN

Recall Details

Product Type
Drugs
Report Date
May 27, 2026
Initiation Date
May 12, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3964 Cartons

Product Description

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 70954-531-20

Reason for Recall

Defective Container; packets were found to be either empty or partially full.

Distribution Pattern

Nationwide in the USA

Code Information

Lot M251109, exp Nov 2027

Other recalls by ANI Pharmaceuticals, Inc.

  • D-0566-2022 Class II — Alprazolam Tablets, USP 1.0 mg, packaged in a) 100-count bottles (NDC 67253-902- (February 15, 2022)
  • D-0567-2022 Class II — Alprazolam Tablets, USP 2.0 mg, packaged in a) 100-count bottles (NDC 67253-903- (February 15, 2022)
  • D-0568-2022 Class II — Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by: U (February 15, 2022)
  • D-0565-2022 Class II — Alprazolam Tablets, USP 0.5 mg, packaged in a) 100-count bottles (NDC 67253-901- (February 15, 2022)
  • D-0564-2022 Class II — Alprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-900 (February 15, 2022)
  • D-0046-2021 Class III — Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetami (October 9, 2020)
  • D-0048-2021 Class III — Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetami (October 9, 2020)
  • D-0045-2021 Class III — Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetami (October 9, 2020)
  • D-0043-2021 Class III — Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetami (October 9, 2020)
  • D-0044-2021 Class III — Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetami (October 9, 2020)