Recall D-0662-2025

US Class II Ongoing · initiated 2025-09-17

Recalling firm

Glenmark Pharmaceuticals Inc., USA, NJ

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)

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