FDA Drug recall D-0789-2026
Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States,…
- FDA Drug
- Class II
- ongoing
- Published 2026-09-02
On 2026-09-02 the FDA classified a Class II recall of Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States,… by Lupin Pharmaceuticals, citing failed content uniformity specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0789-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-03 |
| Published | 2026-09-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
Product
Clobetasol 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.
Reason
Failed content uniformity specifications.
Identifiers
| ndc | 68180-956-01 |
|---|---|
| ndc | 68180-956-02 |
| ndc | 68180-956-03 |
| ndc | 68180-956-04 |
| code_info | Lot#: KB00427, Exp date 4/30/2028; KA00308, Exp date 10/31/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0789-2026%22
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