PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: January 22, 2025 Initiated: December 23, 2024 #D-0203-2025

Product Description

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.

Details

Recalling Firm
Viatris Inc
Units Affected
1,215/30 count bottles
Distribution
USA nationwide.
Location
Canonsburg, PA

Frequently Asked Questions

What product was recalled?
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. Recalled by Viatris Inc. Units affected: 1,215/30 count bottles.
Why was this product recalled?
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 22, 2025. Severity: Moderate. Recall number: D-0203-2025.