D-0789-2026 Class II Ongoing
FDA drug recall D-0789-2026 was initiated by Lupin Pharmaceuticals Inc. on August 3, 2026 and is designated Class II. Reason for recall: Failed content uniformity specifications. The recall status is ongoing. Affected quantity: 5082 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- September 2, 2026
- Initiation Date
- August 3, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5082 tubes
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.
Reason for Recall
Failed content uniformity specifications.
Distribution Pattern
USA Nationwide
Code Information
Lot#: KB00427, Exp date 4/30/2028; KA00308, Exp date 10/31/2026