Glenmark Pharmaceuticals Inc., USA recalls Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colval
Recalled October 1, 2025 · FDA recall D-0662-2025 · Glenmark Pharmaceuticals Inc., USA
Hazard
CGMP Deviations: Market complaints received for gritty texture (grainy) · FDA Class II
Units
13824 tubes
Sold at
Nationwide within the United States
Description
CGMP Deviations: Market complaints received for gritty texture (grainy)
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
Manufacturer(s)
Glenmark Pharmaceuticals Inc., USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →