FDA Drug · D-0543-2026

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

Class II · Ongoing

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

Affected lots / codes — check yours against thisLot M251109, exp Nov 2027

Recalling firm: ANI Pharmaceuticals, Inc., Baudette, MN
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 3964 Cartons
Distribution: Nationwide in the USA
Recall initiated: May 12, 2026
Classified: May 20, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0543-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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