Triamcinolone Acetonide Cream USP — Class III drug recall D-0048-2025
Terminated recall by Padagis US LLC, reported 2024-11-27, distributed nationwide. Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container
| Recall number | D-0048-2025 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Padagis US LLC, Minneapolis, MN, United States |
| Recall initiated | 2024-10-11 |
| Classified | 2024-11-18 |
| Reported by FDA | 2024-11-27 |
| Terminated | 2025-09-29 |
| Distributed | Nationwide (US) |
| Quantity | 10,872 jars |
| Reason classes | potency, specification failure |
| NDC | 45802-0063-05 |
| Lot numbers | 2024154238, 2024174344 |
| Expiration dates | 2026-03-31 |
Product
Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis, Minneapolis, MN 55427. NDC: 45802-0063-05
Reason for recall
Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test 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-0048-2025. 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.