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 |
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.
How to identify the recalled item
| Lot / date codes | Lot#: KB00427, Exp date 4/30/2028; KA00308, Exp date 10/31/2026 |
|---|---|
| Lot / date codes | Lot#: KB00427, Exp date 4/30/2028; KA00308, Exp date 10/31/2026 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
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.