FDA recall D-0662-2025

Glenmark Pharmaceuticals Inc., USA · Class II · drug

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)

Distribution

Nationwide within the United States

Key facts

Status: Ongoing
Initiation date: 2025-09-17
Report date: 2025-10-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0662-2025