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) nationwide because some packets were found to be empty or only partially filled. The affected product is distributed across all U.S. states and the District of Columbia under NDC 70954-531-20. This is a Class II recall, meaning use of the defective product could cause adverse health effects.
- 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/5dcd7d8d-9e2b-4812-97fc-658fe096d85d