FDA recall D-0203-2025

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.

Distribution

USA nationwide.

Key facts

Status

Terminated

Initiation date

2024-12-23

Report date

2025-01-22

Termination date

2025-11-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Canonsburg, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0203-2025