Reported Feb 1, 2023 · Terminated

Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore,…

Lupin Pharmaceuticals Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Lupin Pharmaceuticals Inc. · Harborplace Tower · Baltimore, MD · 21202-6174

Is this the product you have?

  • Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only
  • Manufactured forLupin Pharmaceuticals, Inc. Baltimore, Maryland 21202
  • Manufactured byLupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-956-03
Lot codes and dates
    • Lot#: K101033
    • Exp 6/2024
Amount recalled
5720 tubes

Where it was sold

  • Nationwide

Why it was recalled

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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jan 16, 2024 · Data as of Sep 19, 5:05 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.