CLASS II Drug recall · Reported 31 Oct 2012 · FDA Enforcement Report
Doxazosin Tablets, USP, 2 mg, labeled in part *** recalled
Mylan Pharmaceuticals is recalling Doxazosin Tablets, USP, 2 mg, labeled in part ***, distributed nationwide in the US. The recall was initiated on 7 Aug 2012 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-033-2013
- FDA event ID
- 63284
- Recalling firm
- Mylan Pharmaceuticals, Morgantown, WV
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Aug 2012
- FDA classified
- 25 Oct 2012
- Reported
- 31 Oct 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Blood Pressure Medication
Timeline
| 7 Aug 2012 | Recall initiated by company | |
| 25 Oct 2012 | Classified by FDA | +79 days |
| 31 Oct 2012 | 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
Cross Contamination w/Other Products: During stability testing chromatographic review revealed extraneous peaks identified as acetaminophen and codeine.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Doxazosin Tablets, USP, 2 mg, 100 count bottles, labeled in part ***Manufactured in Australia by: ALPHAPHARM PTY LTD, 15 Garnet Street***Rx Only*** Carole Park QLD 4300, Australia*** Manufactured for Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.SA ***
Where it was distributed
Nationwide.
Questions about this recall
Is Doxazosin Tablets, USP, 2 mg, labeled in part *** recalled?
Yes. Mylan Pharmaceuticals recalled Doxazosin Tablets, USP, 2 mg, labeled in part *** on 7 Aug 2012. The recall is Class II and its status is Terminated. Recall number D-033-2013.
Why was it recalled?
Cross Contamination w/Other Products: During stability testing chromatographic review revealed extraneous peaks identified as acetaminophen and codeine.
Which lots are affected?
Lot A 303M, Exp. June 2014
Where was it sold?
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 21 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 Doxazosin recalls
All 11| 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 | Cardura XL (doxazosin) extended release tablets 8 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 Tablets, USP, 2 mg recalled by Preferred Pharmaceuticals | Preferred Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |