FDA-Drug2025-10-01Class II
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
Hazard
CGMP Deviations: Market complaints received for gritty texture (grainy)
Sold states
Nationwide within the United States
Affected count
13824 tubes
Manufactured in
750 Corporate Dr, N/A, Mahwah, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0662-2025Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.