Nearly 1 million bottles of heart and kidney medication recalled: FDA
Key Points:
- Nearly one million bottles of Amgen's heart and kidney medications, Corlanor and Sensipar, have been voluntarily recalled due to the presence of an unexpected foreign substance on the exterior surface of some tablets.
- The recall affects lots packaged in the AML Building 23 area and includes bottles distributed between October 28, 2021, and December 30, 2025.
- The California Board of Pharmacy and FDA state that the foreign matter does not pose a clinical risk, and overall patient safety risk is considered low, with no complaints reported so far.
- Corlanor (ivabradine) is used to treat chronic heart failure, while Sensipar (cinacalcet hydrochloride) is prescribed for overactive parathyroidism in chronic kidney disease patients.
- The recall covers multiple NDC presentations of both drugs, including various tablet strengths and bottle sizes.