Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Only Made in Singapore, Distributed by Roer... — FDA record D-0603-2024

Reported completed

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Apr 30, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Only Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2080-10
Reason
Failed Impurities/Degradation Specifications
Classification
Class II
Recalling firm
Viatris Inc
Quantity
3,694 bottles
Agency-reported status
Completed
Source record identifier
D-0603-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityLot#: 8147041; Exp. June 2024 Lot#: 8163765; Exp. March 2025

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

U.S. Nationwide

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Jul 24, 2024
Recall initiation date
Apr 30, 2024
Center classification date
Jul 16, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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