CLASS III Drug recall · Reported 6 Aug 2014 · FDA Enforcement Report
Cardura XL (doxazosin mesylate extended release tablets, 4 mg recalled
Pfizer is recalling Cardura XL (doxazosin mesylate extended release tablets, 4 mg, distributed nationwide in the US. The recall was initiated on 19 Jun 2014 and the FDA has classified it as Class III.
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-1485-2014
- FDA event ID
- 68639
- Recalling firm
- Pfizer, New York, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 19 Jun 2014
- FDA classified
- 28 Jul 2014
- Reported
- 6 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 19 Jun 2014 | Recall initiated by company | |
| 28 Jul 2014 | Classified by FDA | +39 days |
| 6 Aug 2014 | Published in enforcement report | +9 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: Product from this lot may not meet specifications for a product degradant.
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 mesylate extended release tablets, 4 mg, 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., New York, NY 10017, NDC 0049-2710-30
Where it was distributed
Nationwide (Continental USA and Puerto Rico). A portion of the bulk lot was supplied to Pfizer Germany for packaging into blisters for non- USA market. One of these lots in Germany was placed in stability having acceptable results, therefore are not part of the recall scope. Only the product distributed within US/PR market (bottles) is in the scope of this recall.
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant.
Which lots are affected?
Lot # V130822; Exp 01/15
Where was it sold?
Nationwide (Continental USA and Puerto Rico). A portion of the bulk lot was supplied to Pfizer Germany for packaging into blisters for non- USA market. One of these lots in Germany was placed in stability having acceptable results, therefore are not part of the recall scope. Only the product distributed within US/PR market (bottles) is in the scope of this recall.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
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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 II | Cardura XL (doxazosin) extended release tablets 8mg recalled by Viatris | Viatris | Potency & Assay | Nationwide |