← FDA ENFORCEMENT
D-0789-2026Class II

Lupin Pharmaceuticals Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Lupin Pharmaceuticals Inc.
Product type
Drug
Status
Ongoing
Report date
2026-09-02
Distribution
USA Nationwide
Firm state
FL
Product quantity
5082 tubes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

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.

Code / lot info

Lot#: KB00427, Exp date 4/30/2028; KA00308, Exp date 10/31/2026

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →