Amgen recalls nearly 1 million bottles of Corlanor and Sensipar

Patients taking Corlanor or Sensipar were told to check the lot number on their bottles after Amgen recalled 944,142 bottles of the two medicines nationwide. The guidance is simple but important: do not stop treatment on your own if you take either drug for heart failure or kidney-related disease; contact a pharmacist or physician first if a bottle matches the recall.

The recall covered Corlanor, the heart-failure drug also known as ivabradine, and Sensipar, which is used for chronic kidney disease and related conditions. The U.S. Food and Drug Administration classified both actions as Class II recalls, a category that means exposure may cause temporary or medically reversible health consequences and the chance of serious harm is considered remote.

California’s Board of Pharmacy said Amgen initiated the recall on June 5 and that it involved 63 lots of Corlanor and three lots of Sensipar. The products were distributed in the United States from October 28, 2021, through December 30, 2025. The board said the issue came from a low-frequency event involving unexpected foreign matter found in a reserve sample, with the material localized on the exterior tablet surface over the coating in Amgen’s AML Building 23 packaging area.

The company said the foreign substance was discovered during inspection, when unexpected foreign matter was found on the surface of some tablets. Amgen said the recall was voluntary and was being carried out out of an abundance of caution to protect patient safety. The health hazard assessment concluded the overall patient safety risk was low, and both the FDA and California regulators said there had been no product complaints tied to the condition.

The scale of the recall matters because both medicines are tied to serious chronic illness. Corlanor, first approved by the FDA in April 2015, is indicated to reduce hospitalization risk in adults with stable, symptomatic chronic heart failure with reduced ejection fraction, and its label also includes a pediatric use for stable symptomatic heart failure due to dilated cardiomyopathy. Sensipar, initially approved in 2004, is indicated for secondary hyperparathyroidism in adults with chronic kidney disease on dialysis.

FDA guidance says Class II recalls are generally handled at the retail level and that patients may continue taking the medicine unless a clinician tells them otherwise. The agency also advises patients to compare the lot number on the label against the recall notice, a small step that can prevent confusion in pharmacies and help keep treatment plans intact for people already managing complex heart and kidney disease.