Class II

Drug Recall: 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., US

Glenmark Pharmaceuticals Inc., USA · September 17, 2025

Reason for Recall

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

Product Description

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

Distribution

Nationwide within the United States

States Affected

NATIONWIDE

Quantity Affected

13824 tubes

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0662-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.