Recalling firm
ANI Pharmaceuticals, Inc.
Product type
Drug
Status
Ongoing
Report date
2026-05-27
Distribution
Nationwide in the USA
Firm state
MN
Product quantity
3964 Cartons
Initiated by
Voluntary: Firm initiated
Reason for recall
Defective Container; packets were found to be either empty or partially full.
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
Code / lot info
Lot M251109, exp Nov 2027
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.