Cardura XL (doxazosin) extended release tablets 4 mg recall
FDA recall D-0204-2025 · initiated Dec 23, 2024
Viatris Inc recalled Cardura XL (doxazosin) extended release tablets 4 mg in Dec 2024 — an FDA Class II recall (D-0204-2025) because Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 6,605/30 count bottles
Details
- Product
- Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-078-93
- Recalling company
- Viatris
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- USA nationwide.
- Initiated
- Dec 23, 2024
- FDA report date
- Jan 22, 2025
This recall is linked to a product we cover: Cardura XL →
Frequently asked
- Was Cardura XL (doxazosin) extended release tablets 4 mg recalled?
- Viatris Inc recalled Cardura XL (doxazosin) extended release tablets 4 mg in Dec 2024 — an FDA Class II recall (D-0204-2025) because Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Cardura XL (doxazosin) extended release tablets 4 mg recalled?
- Per the FDA enforcement record, the reason for recall D-0204-2025 was: Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
- Is a recalled Cardura XL (doxazosin) extended release tablets 4 mg dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Cardura XL (doxazosin) extended release tablets 4 mg are affected?
- Distributed: USA nationwide.. The recall covers these lots — Lot# 8182298, Exp 10/31/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0204-2025.