Lupin Pharmaceuticals Inc.: Clobetasol Propionate Cream Usp, 0.05%

Summary Lupin Pharmaceuticals is recalling Clobetasol Propionate Cream USP, 0.05% (a prescription steroid cream) in 60-gram tubes across the United States because the product failed quality testing for consistent active ingredient levels throughout the tube. This is a Class II recall, meaning the product could cause temporary or reversible health effects or has a remote chance of serious harm.

Recalling firm
Lupin Pharmaceuticals Inc.
Product
Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Pithampur (MP) 454 775, INDIA, NDC 68180-956-04.
Reason
Failed content uniformity specifications.
Classification
Class II
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-08-03
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
USA Nationwide

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/ed85221c-0467-48c6-a65e-72b98a39d266