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FDA · Drugs ·

Azelaic Acid Gel recall

Glenmark Pharmaceuticals Inc., USA recalled Azelaic Acid Gel on August 5, 2026 because of cGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received. It was sold nationwide.

Why it was recalled

CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.

What's recalled

Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52.

Quantity: N/A

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
Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
Nationwide within the United States.
Status
Ongoing
Recall number
D-0731-2026
Source
U.S. Food and Drug Administration

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