Pfizer Recalls Cardura XL Tablets Due to Degradation Specifications
Pfizer is recalling 22,461 bottles of Cardura XL 4 mg tablets because the product may not meet specifications for a product degradant.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, aligning with the Low severity criteria for documentation or minor specification issues.
Plain-English summary
Pfizer Inc. is recalling 22,461 bottles of Cardura XL (doxazosin mesylate extended release tablets, 4 mg, 30-count bottle). The recall is limited to Lot # V130822 with an expiration date of 01/15. The product is distributed by the Roerig Division of Pfizer Inc. in New York, NY.
The recall was initiated because the product from this lot may not meet specifications for a product degradant. This is a Class III recall, which indicates that the violation is not likely to cause adverse health consequences.
The affected product was distributed nationwide in the Continental USA and Puerto Rico. A portion of the bulk lot was supplied to Pfizer Germany for packaging into blisters for the non-USA market, but only the product distributed within the US/PR market in bottles is included in the scope of this recall. Consumers should check their medication for the specific lot number and expiration date and contact their healthcare provider or pharmacist for guidance if they have the affected product.
The recalled product
- Product
- 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
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 22,461
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # V130822
- Exp 01/15
Distribution
Related recalls
Same manufacturer · Pfizer Inc.
See all →- HighSodium bicarbonate injection vials recalled for lack of assurance of sterility
FDA (Drugs) · 2025-08-27
- HighEpinephrine injection vials recalled for lack of assurance of sterility
FDA (Drugs) · 2025-08-27
- HighBicillin L-A 2.4 million unit vials recalled after particulates found
FDA (Drugs) · 2025-08-06
- HighBicillin L-A penicillin vials recalled after particulates found during visual inspection
FDA (Drugs) · 2025-08-06
- ModerateDobutamine Injection Recall Due to Discoloration and Cracked Vials
FDA (Drugs) · 2025-07-02
Similar recalls
- HighCardura XL Tablets Recalled for Failed Impurities and Degradation Specifications
FDA (Drugs) · 2024-07-24
- HighCardura XL Extended Release Tablets Recalled for Failed Impurity Specifications
FDA (Drugs) · 2024-07-24
- HighPrescription Drug Cardura Recalled for Specification Failures in Manufacturing
FDA (Drugs) · 2025-01-22
- ModeratePrescription Drug Cardura XL Recalled for Out-of-Specification Impurity
FDA (Drugs) · 2025-01-22
- LowPfizer Recalls Glucotrol XL Tablets for Dissolution Specification Failure
FDA (Drugs) · 2014-02-12
- ModeratePfizer Recalls Glipizide XL Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2018-10-17