Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34
Summary
The FDA issued a Class II for Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lu by Lupin Pharmaceuticals Inc.. Reason: Failed content uniformity specifications..
Details
Source
Drug Recall
External ID
D-0789-2026
Action Date
2026-09-02
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lot#: KB00427, Exp date 4/30/2028; KA00308, Exp date 10/31/2026
Quantity Affected: 5082 tubes
Reason for Recall
Failed content uniformity specifications.
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-03
Company
Naples, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 38 drug recalls issued in the same week, part of 66 drug-related FDA actions this month.
Lupin Pharmaceuticals Inc. has 52 FDA actions in our database, including 52 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Lupin Pharmaceuticals Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Lupin Pharmaceuticals Inc. have FDA actions?
Lupin Pharmaceuticals Inc. has 52 FDA actions in our database, including 52 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0789-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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