Nearly 1 million bottles of heart and kidney medication recalled over foreign substance found on tablets
Key Points:
- Nearly one million bottles of Corlanor and Sensipar heart and kidney medications have been voluntarily recalled by Amgen, Inc. due to the presence of an unexpected foreign substance on the exterior surface of the tablets.
- The recall affects lots processed in the AML Building 23 packaging area and includes several specific presentations of Corlanor (ivabradine) and Sensipar (cinacalcet hydrochloride) distributed between October 28, 2021, and December 30, 2025.
- The California State Board of Pharmacy and FDA have stated 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 is used to treat chronic heart failure, while Sensipar is prescribed for overactive parathyroidism in chronic kidney disease patients.