The Recall Desk
HighFDA (Drugs)·D-0602-2024·Announced 2024-07-24

Cardura XL Tablets Recalled for Failed Impurities and Degradation Specifications

Viatris Inc is recalling Cardura XL (doxazosin) 4mg tablets due to failed impurities and degradation specifications. The recall affects 12,691 bottles 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: This is an FDA Class II drug recall involving failed quality specifications (impurities and degradation) in a prescription medication. Although no illnesses or injuries have been reported, impurities or degradation in medication pose a potential risk of harm to patients, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Viatris Inc is recalling Cardura XL (doxazosin) extended release tablets, 4mg strength, in 30-count bottles. The recall was initiated because certain lots failed impurities and degradation specifications. The affected lots are: Lot #8147040 (Exp. June 2024) and Lot #8163764 (Exp. March 2025).

A total of 12,691 bottles have been distributed in the United States. Cardura XL is distributed by the Roerig Division of Pfizer Inc, located in New York, NY.

Consumers should stop using affected bottles and contact their healthcare provider or pharmacist. The product is prescription-only and distributed through normal pharmaceutical channels. Anyone who has taken the medication from the recalled lots should consult their healthcare provider.

The recalled product

Product
Cardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Only, Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2040-10
Manufacturer
Viatris Inc
Category
Drug — Prescription Medication
Hazard
Affected units
12,691

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 #: 8147040
  • Exp. June 2024 Lot #: 8163764
  • 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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