Clobetasol Propionate Cream USP — Class II drug recall D-0789-2026
Ongoing recall by Lupin Pharmaceuticals Inc., reported 2026-09-02, distributed nationwide. Failed content uniformity specifications.
| Recall number | D-0789-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Naples, FL, United States |
| Recall initiated | 2026-08-03 |
| Classified | 2026-08-26 |
| Reported by FDA | 2026-09-02 |
| Distributed | Nationwide (US) |
| Quantity | 5,082 tubes |
| NDC | 68180-0956, 68180-0956-01, 68180-0956-02, 68180-0956-03, 68180-0956-04 |
| Lot numbers | KA00308, KB00427 |
| Expiration dates | 2026-10-31, 2028-04-30 |
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 for recall
Failed content uniformity specifications.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0789-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.