Class IIDrug
Clobetasol Propionate Cream USP recall
Summary
Lupin Pharmaceuticals Inc. is recalling Clobetasol Propionate Cream USP (drug). According to the FDA report, the reason is: Failed content uniformity specifications. The FDA rated this a Class II: the product may cause temporary or medically reversible health problems; serious harm is unlikely. Recall status: Ongoing.
Details from the FDA report
- 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.
- Lot / code info
- Lot#: KB00427, Exp date 4/30/2028; KA00308, Exp date 10/31/2026
- Quantity
- 5082 tubes
- Distribution
- USA Nationwide
- Recalling company
- Lupin Pharmaceuticals Inc., Naples, FL United States
- Recall started
- August 3, 2026
- FDA report date
- September 2, 2026
- Classification
- Class II: The product may cause temporary or medically reversible health problems; serious harm is unlikely.
- Voluntary / mandated
- Voluntary: Firm initiated
- Status
- Ongoing
- Recall number
- D-0789-2026
What to do
- Check whether you have this product, and compare the lot numbers, codes, or dates on your package with the codes listed above.
- If it matches, stop using it and keep it away from children and pets.
- Contact the recalling company (Lupin Pharmaceuticals Inc.) or the store where you bought it about returns or refunds.
- Do not stop a prescribed medication without first talking to your pharmacist or doctor; they can help find a safe replacement.
- If you think the product made you or someone else sick, contact a doctor or pharmacist. In an emergency call 911.
- You can report problems to the FDA via MedWatch.