United StatesAzelaic Acid Gel, 15%, 50 gram tubes (Rx only) distributed by Glenmark Pharmaceuticals Inc., Elmwood Park, NJ, NDC 68462-626-52, lots 19260937A (exp Feb 2028); 19261225A and 19261185A (exp Mar 2028); 19261664A and 19261682A (exp Apr 2028). The product was recalled due to CGMP deviations after product quality complaints reporting an abnormal texture or consistency described as grainy, gritty, or sandy.
What's being recalled
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.
Recalling firm: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ, United States.
How to identify it
Lot #: 19260937A, Exp. Date February 2028; 19261225A, 19261185A, Exp. Date March 2028; 19261664A, 19261682A, Exp. Date April 2028.
The hazard
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide within the United States.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)