RecallReported September 2, 2026
Class II recall by Lupin Pharmaceuticals Inc.
Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, …
FDA's enforcement report of September 2, 2026 lists a Class II recall by Lupin Pharmaceuticals Inc. of Naples, FL. Product: Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, …. Status: Ongoing.
On the record
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Location
- Naples, FL
- Classification
- Class II
- Status
- Ongoing
- Recall number
- D-0789-2026
- Product type
- Drugs
- Brand names
- CLOBETASOL PROPIONATE
- Generic names
- CLOBETASOL PROPIONATE
- Recall initiated
- 2026-08-03
- Reported by FDA
- 2026-09-02
The full record
An account shows the reason for the recall, where the product was distributed and the lots.
What a recall is
FDA classifies a recall by the hazard. Class I: a reasonable probability that the product will cause serious adverse health consequences or death. Class II: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: the product is not likely to cause adverse health consequences.
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From FDA enforcement reports. The record may have changed since it was read.
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