Amgen Inc. has initiated a voluntary recall of nearly one million bottles of heart and kidney medications nationwide due to the potential presence of a foreign substance on the tablets. The U.S. Food and Drug Administration (FDA) announced the recall of Corlanor and Sensipar tablets, affecting approximately 944,142 bottles.
The issue was discovered when "unexpected foreign matter" was found on the reserve sample of one of the identified lots. The substance was localized on the exterior tablet surface, over the coating. As a precautionary measure, all lots within expiry that were processed in a specific packaging area are being recalled.
According to the California state Board of Pharmacy, hazard assessments have indicated that the foreign matter does not present a clinical risk to patients, and the overall patient safety risk is considered low. No complaints related to this issue have been reported.
Corlanor, generically known as ivabradine, is prescribed for patients with chronic heart failure. Sensipar, or cinacalcet hydrochloride, is primarily used to manage hyperparathyroidism in patients with chronic kidney disease. The affected tablets were distributed between October 28, 2021, and December 30, 2025.
The recall includes specific presentations of Corlanor (5 mg) and Sensipar (30 mg, 60 mg, and 90 mg) tablets. The FDA has classified the recall as Class II, signifying that the products could cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote.