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
- impurity
- degradation-product
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.
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