Recall: D-0662-2025

Class II - Potentially Harmful

Class IIClassification

2025-09-17Initiated

OngoingStatus

Glenmark Pharmaceuticals Inc.,Firm

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

CGMP Deviations: Market complaints received for gritty texture (grainy)

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.