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Home › FDA recalls › Clobetasol Propionate Cream USP
CLASS II · ModerateFDA

Lupin Pharmaceuticals Inc. recalls Clobetasol Propionate Cream USP

📅 Aug 3, 2026 · 📍 Nationwide
Recalling company
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.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Aug 3, 2026
Reported
Sep 2, 2026
Distribution
USA Nationwide
Status
Ongoing
Quantity
5082 tubes
Lot / codes
Lot#: KB00427, Exp date 4/30/2028; KA00308, Exp date 10/31/2026
Company location
Naples, FL
Recall type
Voluntary: Firm initiated
Recall number
D-0789-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0789-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.