The Recall Desk
HighFDA (Drugs)·D-0603-2024·Announced 2024-07-24

Cardura XL Extended Release Tablets Recalled for Failed Impurity Specifications

Viatris Inc is recalling Cardura XL (doxazosin) extended release tablets 8mg because two lots failed impurity and degradation specifications. Approximately 3,694 bottles were distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II drug recall due to failed impurity and degradation specifications. This qualifies as a risk-of-harm product where injury has not yet been reported, placing it at Score 3 per the severity rubric.

Plain-English summary

Viatris Inc is recalling Cardura XL (doxazosin) extended release tablets, 8mg strength in 30-count bottles, due to failed impurity and degradation specifications.

Two lots have been identified with the quality issue: Lot 8147041 (expiration June 2024) and Lot 8163765 (expiration March 2025). A total of 3,694 bottles were distributed nationwide.

Patients who have received this medication should consult with their physician or pharmacist regarding their specific situation. Healthcare providers and consumers with questions should contact the FDA or Viatris Inc for additional information.

The recalled product

Product
Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Only Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2080-10
Manufacturer
Viatris Inc
Category
Drug
Hazard
Affected units
3,694

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot#: 8147041
  • Exp. June 2024 Lot#: 8163765
  • Exp. March 2025

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Viatris Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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Same hazard · impurity

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