The Recall Desk
Agency classClass IIOur severity: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.

The agency’s classification

FDA (Drugs): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 →

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