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

FDA recall notice · announced January 22, 2025 · Viatris

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

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

Reason for recall

Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.

Notes

Distribution: USA nationwide.
Lot/code information: Lot # 8181625, Exp 12/31/2025
Quantity: 1,215/30 count bottles
Status: Terminated
Products in this recall event:
- 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 (D-0204-2025)
- 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 (D-0203-2025)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.