Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Vi...
FDA Recall #D-0203-2025 — Class II — December 23, 2024
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.
Recalling Firm
Viatris Inc — Canonsburg, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1,215/30 count bottles
Distribution
USA nationwide.
Code Information
Lot # 8181625, Exp 12/31/2025
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated