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FDAMay 12, 2026drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

ani pharmaceuticalsani

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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