FDA recall, , Moderate risk
Lupin Clobetasol Propionate Cream
Clobetasol Propionate Cream USP, 0.05%, 60 g tube failed content uniformity specifications.
Summary by Recall Canary from the FDA notice
What happened
Lupin Pharmaceuticals Inc. of Naples, Florida, recalled Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, because it failed content uniformity specifications. The recall began August 3, 2026, and was added to the FDA's Enforcement Report on August 26, 2026. The product was distributed nationwide in the USA.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is your tube affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Clobetasol Propionate Cream USP, 0.05%, 60 g tube
- NDC
- 68180-956-04
- Lot code
- KB00427
Recall details
- Company began the recall
- Sold in
USA Nationwide
- Company
- Lupin Pharmaceuticals Inc.Naples, Florida
- Hazard
- Quality testing problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99544
- Recall number
- D-0789-2026
- Quantity recalled
- 5082 tubes
All recalls from Lupin Pharmaceuticals Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
