FDA-Drug2026-09-02Class IICHEMICAL
Lupin Clobetasol Propionate Cream recalled for failed content uniformity
What this means
Lupin Pharmaceuticals is recalling specific lots of Clobetasol Propionate Cream USP 0.05% because the active ingredient is not uniformly distributed throughout the product. This means some parts of the cream may contain too much or too little medication, which could affect how well it works.
- Check if you have lot KB00427 (expires 4/30/2028) or KA00308 (expires 10/31/2026).
- Do not use the affected cream.
- Contact your pharmacy or doctor for a replacement prescription.
The agency's original wording
Hazard
Failed content uniformity specifications.
Intended for
Adults
Illnesses reported
None reported
Sold states
USA Nationwide
Affected count
5082 tubes
Manufactured in
5801 Pelican Bay Blvd Ste 500, N/A, Naples, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0789-2026More Lupin recalls
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