Multi event Drug Recall Enforcement Report Class II voluntary initiated by Viatris Inc, originally initiated on 12-23-2024 for the 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 The product was recalled due to failed impurities/degradation specifications: out of specification results observed for the impurity compound b during stability testing.. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0203-2025 | 12-23-2024 | 01-22-2025 | Class II | 1,215/30 count bottles | 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 | Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing. | Ongoing |
| D-0204-2025 | 12-23-2024 | 01-22-2025 | Class II | 6,605/30 count bottles | 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 | Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing. | Ongoing |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 58151-078 | Cardura XL | Doxazosin Mesylate | Tablet, Film Coated, Extended Release | Oral | Viatris Specialty Llc | Human Prescription Drug |
| 58151-079 | Cardura XL | Doxazosin Mesylate | Tablet, Film Coated, Extended Release | Oral | Viatris Specialty Llc | Human Prescription Drug |
