Cardura Tablet, Film Coated, Extended Release
FDA Recall NDC 58151-078
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Cardura (NDC 58151-078). A significant event, classified as Class II, was initiated on Dec 23, 2024 by Viatris Specialty Llc. The reported reason for this action was: "Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
December 2024 Class II Recall: Failed Impurities/Degradation Specifications
Recall Number
Class II Terminated
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Dec 23, 2024
Jan 22, 2025
6,605/30 count bottles
Recall Profile & Regulatory Data
Event ID
96036
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Viatris Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Termination Date
Nov 12, 2025
Product Description
Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-078-93
Batch or Lot Expiration Information
Lot# 8182298, Exp 10/31/2025
Affected Packages Involved in this Recall
58151-078-93Product
58151-079-93Product
December 2024 Class II Recall: Failed Impurities/Degradation Specifications
Recall Number
Class II Terminated
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Dec 23, 2024
Jan 22, 2025
1,215/30 count bottles
Recall Profile & Regulatory Data
Event ID
96036
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Viatris Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Termination Date
Nov 12, 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
Batch or Lot Expiration Information
Lot# 8181625, Exp 12/31/2025
Affected Packages Involved in this Recall
58151-078-93Product
58151-079-93Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
