Multi-event December 2024 FDA Recall Cardura by Viatris Inc
This Multi-event Class II drug recall was voluntarily initiated by Viatris Inc on December 23, 2024 for the product Cardura. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0204-2025
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
12-23-2024
01-22-2025
6,605/30 count bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Viatris Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA nationwide.
11-12-2025
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Recall Number: D-0203-2025
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
12-23-2024
01-22-2025
1,215/30 count bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Viatris Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA nationwide.
11-12-2025
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# 8181625, Exp 12/31/2025
