The Recall Desk
HighFDA (Drugs)·D-0203-2025·Announced 2025-01-22

Prescription Drug Cardura Recalled for Specification Failures in Manufacturing

Viatris Inc is recalling Cardura (doxazosin mesylate) XL 8 mg tablets due to failed stability testing revealing out-of-specification impurity levels. Approximately 1,215 bottles distributed nationwide are affected.

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 pharmaceutical recall for failed impurity specifications discovered during stability testing. Although no illnesses or adverse events have been reported, impurities in prescription medications represent a potential risk of harm warranting this classification.

Plain-English summary

Viatris Inc is recalling Cardura XL (doxazosin mesylate) 8 mg extended-release tablets in 30-count bottles. The recall affects Lot #8181625 with an expiration date of 12/31/2025 (NDC 58151-079-93).

The recall was initiated due to failed manufacturing specifications discovered during stability testing. Out-of-specification results were observed for impurity compound B, meaning the product did not meet the required quality standards for this component.

The affected product was distributed nationwide across the United States. Approximately 1,215 bottles of the 30-count product size are subject to this recall.

Patients with this medication should consult their pharmacist or healthcare provider with any questions about the recall.

The recalled product

Product
CARDURA (DOXAZOSIN MESYLATE)
Brand
CARDURA
Manufacturer
Viatris Inc
Category
Drug — Prescription Medication
Hazard

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 (2)

  • Lot # 8181625
  • Exp 12/31/2025

UPCs (1)

  • 0358151078936

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 →

Related recalls

Same brand · CARDURA

Same manufacturer · Viatris Inc

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Same hazard · impurity

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