Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Azelaic Acid Gel Recalled by Glenmark Pharmaceuticals Inc., USA Due to CGMP Deviations: Market complaints received for gritty texture...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Glenmark Pharmaceuticals Inc., USA directly.
Affected Products
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
Quantity: 13824 tubes
Why Was This Recalled?
CGMP Deviations: Market complaints received for gritty texture (grainy)
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Glenmark Pharmaceuticals Inc., USA
Glenmark Pharmaceuticals Inc., USA has 139 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report