FDA recall D-0789-2026

Lupin Pharmaceuticals Inc. · Class II · drug

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 for recall

Failed content uniformity specifications.

Distribution

USA Nationwide

Key facts

Status
Ongoing
Initiation date
2026-08-03
Report date
2026-09-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Naples, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0789-2026