FDAFDA recall D-0789-2026 · Sep 2, 2026
Lupin Pharmaceuticals Inc.: Clobetasol Propionate Cream USP recall
Recall found
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 for recall
Failed content uniformity specifications.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot#: KB00427, Exp date 4/30/2028; KA00308, Exp date 10/31/2026
- Quantity
- 5082 tubes
- Distribution
- USA Nationwide
- Recalling firm
- Lupin Pharmaceuticals Inc., Naples, FL
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-03
Source: openFDA enforcement record D-0789-2026 · search recall number D-0789-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.