Glenmark Pharmaceuticals Inc. USA recalls 13,824 tubes of azelaic acid gel 15% after CGMP deviations prompted gritty texture complaints. The recall covers nationwide distribution in the United States. Consumers should stop using the product and contact Glenmark for guidance.
CGMP Deviations: Market complaints received for gritty texture (grainy)
Consumers and healthcare providers should stop using this product immediately. Contact Glenmark Pharmaceuticals Inc., USA or your healthcare provider for guidance. Notification method: Letter
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Azelaic acid gel is a topical treatment used for various dermatologic conditions. It is Rx-only in the U.S. and distributed nationwide.
Gritty texture indicates CGMP deviations possibly affecting product quality and safety of application.
This recall is not part of a broader industry pattern, based on provided notice.
Consumers may experience quality concerns or irritation due to altered texture; no injuries reported in the notice.
Recall letter from Glenmark and FDA enforcement page D-0662-2025.
Refunds/replacements typically processed within 4-8 weeks after submission.
Keep recall letter, batch numbers, expiration date, and receipts as records.
Brand: Glenmark Pharmaceuticals. Product: Azelaic Acid Gel, 15%, 50 g. NDC: 68462-626-52. Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. Batch: 19252524. Expiration: May 2027. Sold as Rx only. Quantity: 13,824 tubes. Distribution: Nationwide in the United States.
No injuries or incidents are detailed in the recall notice.
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