ANI Pharmaceuticals, Inc. recalls Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, In
Recalled May 27, 2026 · FDA recall D-0543-2026 · ANI Pharmaceuticals
Hazard
Defective Container; packets were found to be either empty or partially full. · FDA Class II
Units
3964 Cartons
Sold at
Nationwide in the USA
Description
Defective Container; packets were found to be either empty or partially full.
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
Manufacturer(s)
ANI Pharmaceuticals, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →