FILE - A U.S. Food and Drug Administration building is seen behind FDA logos at a bus stop on the agency’s campus in Silver Spring, Md., on Aug. 2, 2018. (AP Photo/Jacquelyn Martin, File ...

A recall which was issued across nine states has now been given the highest risk classification by the federal agency.

Just as the pressure to cut prices is building, a new strategy has emerged to help mitigate risk: breakthrough status. Last July, the FDA introduced a new process to speed up approvals for ...