FDA recall D-0731-2026

Glenmark Pharmaceuticals Inc., USA · Class II · drug

Product

Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52.

Reason for recall

CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.

Distribution

Nationwide within the United States.

Key facts

Status
Ongoing
Initiation date
2026-07-23
Report date
2026-08-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Elmwood Park, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0731-2026