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5h ago

Drugmakers Recall 580,844 Prazosin Bottles Over Cancer-Linked Impurity After FDA Class II Flag

Patients are urged to verify lot numbers and work with their pharmacists or prescribers for safe replacements rather than stopping treatment on their own.

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)
FILE - The Food and Drug Administration seal is seen at the Hubert Humphrey Building Auditorium in Washington, April 22, 2025. (AP Photo/Jose Luis Magana, File)

Overview

  • Teva Pharmaceuticals and distributor Amerisource Health Services initiated nationwide voluntary recalls of select prazosin hydrochloride capsules, with FDA classification posted Oct. 24.
  • Testing found N‑nitroso Prazosin impurity C above the FDA’s CPCA acceptable intake limits in certain lots across 1 mg, 2 mg and 5 mg strengths.
  • The FDA designated the action a Class II recall, indicating the likelihood of serious adverse health consequences is remote, and directed removal of affected lots from circulation.
  • A total of 580,844 bottles are impacted—181,659 (1 mg), 291,512 (2 mg) and 107,673 (5 mg)—spanning multiple bottle sizes, with specific NDCs, lots and expirations listed by the agency.
  • Teva said the recall was coordinated with the FDA and reported no related complaints to date; a California Board of Pharmacy memo cited the company’s assessment of overall risk as medium.