CLASS II Drug recall · Reported 24 Jul 2024 · FDA Enforcement Report
Cardura XL (doxazosin) extended release tablets 8mg recalled by Viatris
Viatris is recalling Cardura XL (doxazosin) extended release tablets 8mg, distributed nationwide in the US. The recall was initiated on 30 Apr 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0603-2024
- FDA event ID
- 94519
- Recalling firm
- Viatris, Canonsburg, PA
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 30 Apr 2024
- FDA classified
- 16 Jul 2024
- Reported
- 24 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 30 Apr 2024 | Recall initiated by company | |
| 16 Jul 2024 | Classified by FDA | +77 days |
| 24 Jul 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Only Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2080-10
Where it was distributed
U.S. Nationwide
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications
Which lots are affected?
Lot#: 8147041; Exp. June 2024 Lot#: 8163765; Exp. March 2025
Where was it sold?
U.S. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 94519| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Cardura XL (doxazosin) extended release tablets 4mg recalled by Viatris | Viatris | Potency & Assay | Nationwide |
More recalls from Viatris
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Xanax XR, alprazolam, extended-release tablets, 3 mg recalled by ViatrisXanax | Viatris | Potency & Assay | Nationwide |
| Drug | CLASS II | Cardura XL (doxazosin) extended release tablets 4 mg recalled by ViatrisCardura | Viatris | Potency & Assay | Nationwide |
| Drug | CLASS II | Cardura XL (doxazosin) extended release tablets 8 mg recalled by ViatrisCardura | Viatris | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets USP, 25 mcg recalled by ViatrisLevothyroxine Sodium | Viatris | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets USP, 75 mcg recalled by ViatrisLevothyroxine Sodium | Viatris | Potency & Assay | Nationwide |
Other Cardura Xl (doxazosin recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cardura XL (doxazosin) extended release tablets 4mg recalled by Viatris | Viatris | Potency & Assay | Nationwide |
| Drug | CLASS III | Cardura XL (doxazosin mesylate extended release tablets, 4 mg recalled | Pfizer | Potency & Assay | Nationwide |