FDA (Drugs) recall action 96036
The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
The agency’s own wording, quoted from the enforcement report.
Viatris is recalling Cardura XL (doxazosin) 4 mg extended-release tablets nationwide due to out-of-specification impurity results detected during stability testing.
Viatris Inc is recalling Cardura (doxazosin mesylate) XL 8 mg tablets due to failed stability testing revealing out-of-specification impurity levels. Approximately 1,215 bottles distributed nationwide are affected.