The Recall Desk
ModerateFDA (Drugs)·D-0204-2025·Announced 2025-01-22

Prescription Drug Cardura XL Recalled for Out-of-Specification Impurity

Viatris is recalling Cardura XL (doxazosin) 4 mg extended-release tablets nationwide due to out-of-specification impurity results detected during stability testing.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall for out-of-specification impurity detected during stability testing with no reported illnesses or injuries, consistent with a voluntary precautionary quality control recall.

Plain-English summary

Viatris Inc is recalling Cardura XL (doxazosin mesylate) 4 mg extended-release tablets distributed nationwide. The recall affects lot number 8182298 (expiration 10/31/2025), totaling approximately 6,605 bottles (30-count each).

Stability testing revealed out-of-specification results for an impurity compound. The FDA classified this as a Class II recall. This is a quality control issue identified during the company's testing process.

The recalled product

Product
CARDURA (DOXAZOSIN MESYLATE)
Brand
CARDURA
Manufacturer
Viatris Inc
Category
Drug — Prescription Drug
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# 8182298
  • Exp 10/31/2025

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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