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

Amgen, Inc. has recalled nearly one million bottles of medication used to treat heart and kidney conditions. The California-based company identified a potential issue with 'unexpected foreign matter' in reserve samples. The recall affects Corlanor and Sensipar tablets distributed across the US. The recall covers at least 944,142 bottles of Corlanor and Sensipar. These tablets were distributed between 28 October 2021 and 30 December 2025. The affected products include various strengths and quantities of both medications.

Corlanor is prescribed for chronic heart failure patients. Sensipar is used primarily for treating overactive parathyroidism in chronic kidney disease patients. The foreign matter was found on the tablet coating, not inside the medication itself.

The FDA classified the recall as Class II. This means the issue could cause temporary or reversible health problems. However, the risk to patients remains low, and no complaints have been reported so far. The foreign substance poses no clinical risk to patients, as it was only on the tablet surface. The recall aims to prevent any potential adverse effects. Amgen has taken action to ensure patient safety and compliance with regulations.