Ani Pharmaceuticals, Inc.: Estradiol Gel, 0.1%, 0.25 Mg, 0
Estradiol Gel Recall Summary ANI Pharmaceuticals is recalling Estradiol Gel 0.1% (0.25 mg packets) because some packets in affected cartons were found to be empty or only partially filled, meaning patients may not receive the correct dose. The recall affects this medication distributed nationwide across all U.S. states and Washington, D.C. Patients currently using this product should check their medication packets.
- Recalling firm
- ANI Pharmaceuticals, Inc.
- Product
- 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
- Defective Container; packets were found to be either empty or partially full.
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-05-12
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide in the USA
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/0cc0326a-8af4-4ba8-9be6-32464a4a9ebf