Class IIReported 2025-10-01
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
Recalled by Glenmark Pharmaceuticals Inc., USA
Reason for Recall
CGMP Deviations: Market complaints received for gritty texture (grainy)
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Recall NumberD-0662-2025ClassificationClass IIStatusOngoingCategorydrugInitiated2025-09-17Reported2025-10-01DistributionNationwide within the United StatesCode InfoBatch # 19252524, Exp Date: May 2027Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.