FDA Media Alert Detail

Drug Recall

FDA Drug Recall: Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals,...

  • U.S. Food and Drug Administration
  • September 2, 2026
  • ID: D-0789-2026

Drug Enforcement Report Details

Recall NumberD-0789-2026
Recalling FirmLupin Pharmaceuticals Inc.
ClassificationClass II
Voluntary / MandatedVoluntary: Firm initiated
Distribution PatternUSA Nationwide
StatusOngoing
Product Description

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 for Recall

Failed content uniformity specifications.

Code Information

Lot#: KB00427, Exp date 4/30/2028; KA00308, Exp date 10/31/2026


Content syndicated from the U.S. Food and Drug Administration (FDA) drug enforcement reports database.