CLASS II Drug recall · Reported 22 Jan 2025 · FDA Enforcement Report
Cardura XL (doxazosin) extended release tablets 8 mg recalled by Viatris
Viatris is recalling Cardura XL (doxazosin) extended release tablets 8 mg, distributed nationwide in the US. The recall was initiated on 23 Dec 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-0203-2025
- FDA event ID
- 96036
- Recalling firm
- Viatris, Canonsburg, PA
- Brand
- Cardura
- Manufacturer
- Viatris Specialty LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Dec 2024
- FDA classified
- 16 Jan 2025
- Reported
- 22 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 23 Dec 2024 | Recall initiated by company | |
| 16 Jan 2025 | Classified by FDA | +24 days |
| 22 Jan 2025 | Published in enforcement report | +6 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: Out of specification results observed for the impurity compound B during stability testing.
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 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-079-93
Where it was distributed
USA nationwide.
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Which lots are affected?
Lot # 8181625, Exp 12/31/2025
Where was it sold?
USA 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 96036| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Cardura XL (doxazosin) extended release tablets 4 mg recalled by ViatrisCardura | 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 | 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 |
| Drug | CLASS II | Levothyroxine Sodium Tablets USP, 88 mcg recalled by ViatrisLevothyroxine Sodium | Viatris | Potency & Assay | Nationwide |
Other Doxazosin recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Doxazosin Tablets, USP, 4 mg recalled by Unichem Pharmaceuticals USADoxazosin Mesylate | Unichem Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Cardura XL (doxazosin) extended release tablets 4 mg recalled by ViatrisCardura | Viatris | Potency & Assay | Nationwide |
| Drug | CLASS II | Doxazosin Tablets, USP, 4mg recalled by Northwind PharmaceuticalsDoxazosin | Northwind Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Doxazosin 2 mg tablets, packaged in a) 30-count recalled by RemedyRepack | RemedyRepack | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Doxazosin Tablets, USP, 2 mg recalled by Preferred Pharmaceuticals | Preferred Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |