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Class II · ModerateActive recall

Clobetasol Propionate

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot#: KB00427, Exp date 4/30/2028; KA00308, Exp date 10/31/2026
Where it was soldUSA Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed content uniformity specifications.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byLupin Limited, Pithampur (MP) 454 775, INDIA foreign manufacturer
Brand nameCLOBETASOL PROPIONATE
Generic nameCLOBETASOL PROPIONATE
Active ingredient(s)CLOBETASOL PROPIONATE
Distributed by / forLupin Pharmaceuticals, Inc., Naples, FL 34108, United States
NDC68180-956-04
Show the full FDA record
Full product labelClobetasol 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.
Recalling firmLupin Pharmaceuticals Inc.
DistributionUSA Nationwide
Quantity5082 tubes
Recall initiated2026-08-03
Report date2026-09-02
Recall completed—
Recall numberD-0789-2026
ClassificationClass II
FDA statusOngoing
Origin on fileNaples FL United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.