FDA Drug · D-0662-2025

Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-626-52

Class II · Ongoing

CGMP Deviations: Market complaints received for gritty texture (grainy)

Affected lots / codes — check yours against thisBatch # 19252524, Exp Date: May 2027

Recalling firm: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 13824 tubes
Distribution: Nationwide within the United States
Recall initiated: September 17, 2025
Classified: September 24, 2025
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0662-2025%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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