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Class III · Lower riskRecall completed

Clobetasol Propionate

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot#: K101033; Exp 6/2024
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

Subpotent Drug: Low assay result observed during long-term stability testing.

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 (M.P.) 454 775, India foreign manufacturer
Brand nameCLOBETASOL PROPIONATE
Generic nameCLOBETASOL PROPIONATE
Active ingredient(s)CLOBETASOL PROPIONATE
Distributed by / forLupin Pharmaceuticals, Inc. Baltimore, Maryland 21202
NDC68180-956-03
Show the full FDA record
Full product labelClobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-956-03
Recalling firmLupin Pharmaceuticals Inc.
DistributionUSA Nationwide
Quantity5720 tubes
Recall initiated2023-01-20
Report date2023-02-01
Recall completed2024-01-16
Recall numberD-0174-2023
ClassificationClass III
FDA statusTerminated
Origin on fileBaltimore MD 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.