FDA Drugs recall ·
Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only… recall
- Recall number
- D-0789-2026
- Date
- (initiated August 3, 2026)
- Company / brand
- Lupin Pharmaceuticals Inc.
5801 Pelican Bay Blvd Ste 500, Naples, FL, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 5082 tubes
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Failed content uniformity specifications.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot#: KB00427, Exp date 4/30/2028; KA00308, Exp date 10/31/2026
Distribution
USA Nationwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0789-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.