Clobetasol Propionate Cream USP recall (Lupin Pharmaceuticals Inc.)
DrugClass IIOngoing
Summary: Lupin Pharmaceuticals Inc. is recalling 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.
What is being recalled
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.
Why
Failed content uniformity specifications.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
USA Nationwide
How to tell if yours is affected
Lot#: KB00427, Exp date 4/30/2028; KA00308, Exp date 10/31/2026
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0789-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 3, 2026 |
| Reported | September 2, 2026 |
| Company | Lupin Pharmaceuticals Inc. |
| Company location | Naples, FL, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 5082 tubes |
More recalls from Lupin Pharmaceuticals Inc. · all drug recalls · recalls from August 2026