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.
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 3/5 (High).
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.
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