Class III · Low risk
Doxazosin Tablets
Tablets/Capsules Imprinted with Wrong ID
Cardura XL
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
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
Affected NDC
0049-2710-30
Compare with the code on your package — it is the most precise check available.
Drug: Doxazosin
- Recalling firm
- Pfizer Inc.
- NDC code
- 0049-2710-30
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1485-2014 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Doxazosin recalls
See all
Class II · Moderate risk
Cardura XL
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Class II · Moderate risk
Cardura XL
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Class II · Moderate risk
Cardura XL
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Cardura XL
Failed Impurities/Degradation Specifications
Other recalls by Pfizer Inc.
All 2014 recalls
Class II · Moderate risk
Dopamine HCl Inj.
Lack of Assurance of Sterility
Class II · Moderate risk
Vial Label: 8.4% Sodium Bicarbonate Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Vial Label: Epinephrine Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Levoxyl (levothyroxine sodium tablets, USP)
Subpotent drug
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.