Amgen recalls nearly 1M bottles of heart and kidney drugs over foreign matter

California-based Amgen, Inc. has recalled nearly one million bottles of Corlanor and Sensipar tablets. The decision follows the discovery of unexpected foreign matter in one lot of the medication. The recall affects six different presentations of the tablets. The recalled tablets were distributed across the US between 28 October 2021 and 30 December 2025. The foreign matter was found on the exterior surface of the tablets, over the coating. According to the company, it does not pose a clinical risk to patients.

The FDA has classified the recall as Class II. This means the issue could cause temporary or reversible health problems, but the chance of serious harm is low. So far, no complaints related to the issue have been reported.

Corlanor is used to treat chronic heart failure. Sensipar is prescribed for patients with overactive parathyroidism linked to chronic kidney disease. The recall involves at least 944,142 bottles of medication. Amgen has stated that the overall patient safety risk remains low. The company continues to monitor the situation closely.