Recall D-0543-2026

US Class II Ongoing · initiated 2026-05-12

Recalling firm

ANI Pharmaceuticals, Inc., MN

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 for recall

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

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