Amgen recalls nearly 1M heart and kidney medication bottles over contamination concerns

California-based Amgen, Inc. has recalled nearly one million bottles of heart and kidney medication. The affected products include Corlanor and Sensipar tablets. The recall follows the discovery of potential foreign matter on some tablet surfaces. The company announced the recall of at least 944,142 bottles distributed between October 28, 2021, and December 30, 2025. The foreign matter was found on the exterior coating of tablets in one identified lot processed in AML Building 23 packaging area. As a precaution, all lots within expiry from this area have been recalled.

The recalled products cover various strengths and quantities of Corlanor and Sensipar. Despite the issue, no complaints have been reported so far. Hazard assessments confirmed that the foreign matter poses a low clinical risk to patients. The FDA has classified this as a Class II recall, meaning it could cause temporary or reversible health issues. Amgen has taken the step to ensure patient safety. The overall risk remains low, according to the company’s evaluation.