Product: 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
Reason for recall: CGMP Deviations: Market complaints received for gritty texture (grainy)
Recall initiated: 20250917
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated