US Drug Recall Register
Class III · Low risk Terminated Initiated Jun 19, 2014 (12 years ago)

Cardura XL

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant.

What was recalled

Cardura XL (doxazosin mesylate extended release tablets, 4 mg, 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., New York, NY 10017, NDC 0049-2710-30

Recalling firm
Pfizer Inc.
NDC code
0049-2710-30
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1485-2014

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Doxazosin recalls

See all
Class III · Low risk Ongoing

Doxazosin Tablets

Reason Tablets/Capsules Imprinted with Wrong ID

Unichem Pharmaceuticals USA Inc. NDC 29300-353-10 D-0306-2026
Class II · Moderate risk Terminated

Cardura XL

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

Cardura XL

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

Cardura XL

Reason Failed Impurities/Degradation Specifications

Viatris Inc NDC 0049-2080-10 D-0603-2024
Class II · Moderate risk Completed

Cardura XL

Reason Failed Impurities/Degradation Specifications

Viatris Inc NDC 0049-2040-10 D-0602-2024