Why it was recalled
Failed content uniformity specifications.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot#: KB00427, Exp date 4/30/2028; KA00308, Exp date 10/31/2026
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0789-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 3, 2026
- FDA report date
- Sep 2, 2026
- Quantity
- 5082 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0789-2026, exactly as published.
Show all FDA fields
- City
- Naples
- State
- FL
- Status
- Ongoing
- Country
- United States
- Event ID
- 99544
- Address
- 5801 Pelican Bay Blvd Ste 500
- Code information
- Lot#: KB00427, Exp date 4/30/2028; KA00308, Exp date 10/31/2026
- Postal code
- 34108-2734
- Report date
- Sep 2, 2026
- Product type
- Drugs
- Recall number
- D-0789-2026
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 5082 tubes
- Reason for recall
- Failed content uniformity specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Aug 3, 2026
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Aug 26, 2026