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3h ago

FDA Class II Recall Targets 580,000 Prazosin Bottles for Nitrosamine Overages

The FDA says certain Teva lots surpassed acceptable CPCA limits for a nitrosamine, a risk level judged unlikely to cause serious harm.

The logo of the US Food and Drug Administration (FDA) is seen on a sign outside the agency's White Oak campus in Silver Spring, Maryland, on July 17, 2025. (Photo by Issam AHMED / AFP) (Photo by ISSAM AHMED/AFP via Getty Images)
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Overview

  • Teva initiated the voluntary recall on Oct. 7, and the FDA classified it as Class II on Oct. 24 with enforcement reports listing affected lots and NDCs.
  • The impurity, identified as N-nitroso Prazosin impurity C, tested above the agency’s acceptable intake limits under its CPCA framework.
  • The action covers 580,844 bottles across three strengths: 1 mg (181,659), 2 mg (291,512) and 5 mg (107,673).
  • Amerisource Health Services reported related voluntary recalls of prazosin capsules distributed nationwide.
  • Patients are advised to verify lot numbers and consult their pharmacy or prescriber rather than stop therapy; Teva reports no relevant complaints to date and rated overall patient harm as medium.