Amgen recalls 1M heart and kidney drugs over foreign substance concerns

California-based Amgen, Inc. has voluntarily recalled nearly one million bottles of heart and kidney medication. The recall affects Corlanor and Sensipar tablets due to the presence of an unexpected foreign substance. The company confirmed no complaints have been received about the issue so far. The recall covers six different presentations of Corlanor and Sensipar. These tablets were distributed nationwide between 28 October 2021 and 30 December 2025. Corlanor treats chronic heart failure, while Sensipar is used for overactive parathyroidism in chronic kidney disease patients.

The foreign matter was found on the exterior surface of the tablets, over the coating. The FDA classified the recall as Class II, meaning the risk of serious harm is low. The substance does not pose a clinical risk to patients, and the overall patient safety risk remains minimal. Amgen has taken action to remove the affected lots from circulation. The company insists the issue does not threaten patient health. The recall remains precautionary, with no reports of adverse effects linked to the foreign matter.