FDA Drug recall D-0203-2025
Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505,…
- FDA Drug
- Class II
- terminated
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class II recall of Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505,… by Viatris, citing failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0203-2025 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-12-23 |
| Published | 2025-01-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Viatris |
| Distribution | US |
Product
Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-079-93
Reason
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Identifiers
| ndc | 58151-078-93 |
|---|---|
| ndc | 58151-079-93 |
| code_info | Lot # 8181625, Exp 12/31/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0203-2025%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.