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FDA · Drugs ·

Estradiol Gel recall

ANI Pharmaceuticals, Inc. recalled Estradiol Gel on May 27, 2026 because of defective Container; packets were found to be either empty or partially full. It was sold nationwide.

Why it was recalled

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

What's recalled

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

Quantity: 3964 Cartons

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
ANI Pharmaceuticals, Inc., Baudette, MN
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
Nationwide in the USA
Status
Ongoing
Recall number
D-0543-2026
Source
U.S. Food and Drug Administration

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