Cardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Only, Made in…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Recalling firm

Viatris Inc

NDC code

0049-2040-10

Origin

PA, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0602-2024

Other Doxazosin recalls

See all

Class III · Low risk Ongoing Jan 21, 2026

Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceuticals (USA), Inc., 1 Tower…

Reason Tablets/Capsules Imprinted with Wrong ID

Unichem Pharmaceuticals USA Inc. NDC 29300-353-10 D-0306-2026

Class II · Moderate risk Terminated Dec 23, 2024

Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only, Distributed by Viatris Specialty LLC…

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

Viatris Inc NDC 58151-078-93 D-0204-2025

Class II · Moderate risk Terminated Dec 23, 2024

Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown…

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

Viatris Inc NDC 58151-079-93 D-0203-2025

Class II · Moderate risk Completed Apr 30, 2024

Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Only Made in Singapore, Distributed by Roerig Division…

Reason Failed Impurities/Degradation Specifications

Viatris Inc NDC 0049-2080-10 D-0603-2024

Class II · Moderate risk Ongoing Mar 23, 2023

Doxazosin Tablets, USP, 4 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7149-1

Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Preferred Pharmaceuticals, Inc. NDC 68788-7149-1 D-0515-2023