Clobetasol propionate Cream USP — Class III drug recall D-0174-2023
Terminated recall by Lupin Pharmaceuticals Inc., reported 2023-02-01, distributed nationwide. Subpotent Drug: Low assay result observed during long-term stability testing.
| Recall number | D-0174-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2023-01-20 |
| Classified | 2023-01-23 |
| Reported by FDA | 2023-02-01 |
| Terminated | 2024-01-16 |
| Distributed | Nationwide (US) |
| Quantity | 5,720 tubes |
| Reason classes | potency, specification failure |
| NDC | 68180-0956, 68180-0956-01, 68180-0956-02, 68180-0956-03, 68180-0956-04 |
| Lot numbers | K101033 |
| Expiration dates | 2024-06 |
Product
Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-956-03
Reason for recall
Subpotent Drug: Low assay result observed during long-term stability testing.
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-0174-2023. 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.