Cardura XL — Class II drug recall D-0204-2025
Terminated recall by Viatris Inc, reported 2025-01-22, distributed nationwide. Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound
| Recall number | D-0204-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Viatris Inc, Canonsburg, PA, United States |
| Recall initiated | 2024-12-23 |
| Classified | 2025-01-16 |
| Reported by FDA | 2025-01-22 |
| Terminated | 2025-11-12 |
| Distributed | Nationwide (US) |
| Quantity | 6,605 |
| Reason classes | specification failure |
| NDC | 58151-0078, 58151-0078-93, 58151-0079, 58151-0079-93 |
| Lot numbers | 8182298 |
| Expiration dates | 2025-10-31 |
Product
Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-078-93
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during 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-0204-2025. 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.