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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

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

Class II Medicine & devices FDA May 27, 2026 Reached Texas
Read the official FDA notice →

What to do

Stop using the product and check it against the description above. Follow the remedy on the official notice; most recalls are refunded or replaced without a receipt. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.

Details

Recalling company
ANI Pharmaceuticals, Inc. — Baudette, MN
Severity
Class II — moderate
Reported
May 27, 2026
Quantity
3964 Cartons
Recall number
D-0543-2026
Status
Ongoing
Source
FDA

Where it went

Nationwide in the USA

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