Cardura XL (doxazosin) extended release tablets 4mg recall
FDA recall D-0602-2024 · initiated Apr 30, 2024
Viatris Inc recalled Cardura XL (doxazosin) extended release tablets 4mg in Apr 2024 — an FDA Class II recall (D-0602-2024) because Failed Impurities/Degradation Specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Impurities/Degradation Specifications
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
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: 12,691 bottles
Details
- 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
- Recalling company
- Viatris
- Classification
- Class II
- Status
- Completed
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide
- Initiated
- Apr 30, 2024
- FDA report date
- Jul 24, 2024
Frequently asked
- Was Cardura XL (doxazosin) extended release tablets 4mg recalled?
- Viatris Inc recalled Cardura XL (doxazosin) extended release tablets 4mg in Apr 2024 — an FDA Class II recall (D-0602-2024) because Failed Impurities/Degradation Specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Cardura XL (doxazosin) extended release tablets 4mg recalled?
- Per the FDA enforcement record, the reason for recall D-0602-2024 was: Failed Impurities/Degradation Specifications
- Is a recalled Cardura XL (doxazosin) extended release tablets 4mg 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 4mg are affected?
- Distributed: U.S. Nationwide. The recall covers these lots — Lot #: 8147040; Exp. June 2024 Lot #: 8163764; Exp. March 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-0602-2024.