Lupin Pharmaceuticals Inc. Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only Recall
Announced 2026-09-02 · FDA
FDA is recalling Lupin Pharmaceuticals Inc.'s Clobetasol Propionate Cream USP, 0.05%, 60 g tubes (Rx Only) due to failed content uniformity specifications. About 5,082 tubes distributed nationwide in the United States are involved across two lots: KB00427 (exp 4/30/2028) and KA00308 (exp 10/31/2026).
| Brand | 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. |
| Severity | moderate |
| Units affected | 5082 |
| Distribution | USA Nationwide |
| Agency | FDA |
| Recall / campaign no. | Lot#: KB00427, Exp date 4/30/2028; KA00308, Exp date 10/31/2026 |
WHAT YOU SHOULD DO
- Do not use this product if you have it.
- Check your tubes for Lot KB00427 (exp 4/30/2028) or Lot KA00308 (exp 10/31/2026).
- Contact Lupin Pharmaceuticals for recall instructions or talk to your pharmacist/healthcare provider for guidance.
- Follow the return or disposal instructions provided by Lupin or the FDA.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.