Nearly 1 million bottles of heart and kidney medication recalled over foreign substance

The U.S. Food and Drug Administration has issued a nationwide recall of nearly one million bottles of heart and kidney medication after the possibility of foreign material in reserve samples. The FDA classified the recall as Class II. California-based Amgen voluntarily recalled at least 944,142 bottles of Corlanor and Sensipar tablets following discovery of unexpected foreign matter localized on the exterior tablet surface over the coating, according to the California State Board of Pharmacy alert. The recall covers lots processed in an AML Building 23 packaging area where the condition occurred, affecting all lots within expiry. Hazard assessments found no clinical risk and overall patient safety risk is low, and there were no complaints. Corlanor (ivabradine) and Sensipar (cinacalcet hydrochloride) were distributed from Oct. 28, 2021 to Dec. 30, 2025.