Glenmark Pharmaceuticals Inc., USA: Mometasone Furoate Cream Recalled for Gritty Texture

What You Should Do

1. Check your prescription cream packaging to see if it is Mometasone Furoate Cream USP, 0.1%, in either a 15-gram (NDC 68462-192-17) or 45-gram (NDC 68462-192-55) tube.
2. Verify the lot numbers and expiration dates on your tube. Affected 15-gram lots include 05171238, 05171248, 05171249 (Exp Jul-2019); 05171582, 05171612 (Exp Aug-2019); 05171674, 05171675, 05171682 (Exp Sep 2019); 05180065, 05180066 (Exp Dec 2019); 05180264, 05180265, 05180275, 0518276 (Exp Jan 2020); 05180411, 05180412, 05180422 (Exp Jan 2020); 05180556, 05180568 (Exp Feb-2020); 05180889, 05180890, 05180896, 05180897 (Exp Apr 2020); 05181123, 05181129, 05181134, 05181135 (Exp May 2020); 05181415, 05181425, 05181429, 05181433 (Exp Jun 2020); 05181528 (Exp Jul 2020); and 05181747, 05181748 (Exp Aug 2020).
3. Affected 45-gram lots include codes such as 05171207, 05171212, 05171213, 05171232, 05171233 (Exp Jul-2019); 05171476 through 05181781 with expiration dates ranging from August 2019 to August 2020. Consult the full product list for all 70+ affected lot numbers.
4. Contact your healthcare provider or pharmacist for guidance regarding your treatment and to obtain a replacement prescription if necessary.
5. Return any unused or gritty product to the pharmacy where it was purchased for a refund and contact Glenmark Pharmaceuticals for further instructions.
6. If you have additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Your Remedy Options

Affected Products