FDA Drug recall D-0174-2023
Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc
- FDA Drug
- Class III
- terminated
- Published 2023-02-01
On 2023-02-01 the FDA classified a Class III recall of Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc by Lupin Pharmaceuticals, citing subpotent Drug: Low assay result observed during long-term stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0174-2023 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2023-01-20 |
| Published | 2023-02-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
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
Subpotent Drug: Low assay result observed during long-term stability testing.
Identifiers
| ndc | 68180-956-01 |
|---|---|
| ndc | 68180-956-02 |
| ndc | 68180-956-03 |
| ndc | 68180-956-04 |
| code_info | Lot#: K101033; Exp 6/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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All Lupin Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0174-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.