Nearly 1 million bottles of heart, kidney medications recalled nationwide over 'foreign substance'

Testing that raised concerns about possible foreign contamination has triggered a recall in the United States of nearly 1 million bottles of two prescription drugs taken by heart and kidney patients.

Amgen, Inc. said the affected products are Corlanor and Sensipar tablets, and officials have indicated the danger to patients appears limited.

What happened?

Amgen and state pharmacy officials said at least 944,142 bottles are being recalled after reserve-sample testing tied to one lot revealed "unexpected foreign matter." The California State Board of Pharmacy said the material was detected on the outside of a tablet.

According to Fox Business, Corlanor is the brand name for ivabradine, a medication used to treat chronic heart failure, while Sensipar is cinacalcet hydrochloride, used to treat overactive parathyroidism in patients with chronic kidney disease.

Those tablets were distributed between Oct. 28, 2021, and Dec. 30, 2025. Because the issue was tied to a particular packaging area, the California State Board of Pharmacy said a precautionary recall was expanded to include all unexpired lots from that location.

Why does it matter?

In its hazard review, the California State Board of Pharmacy said the issue presents no clinical risk to patients and that the "overall patient safety risk is low."

The U.S. Food and Drug Administration placed the action in its Class II recall category, meaning the products could "cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."

What's being done?

Amgen has already initiated the recall, and the FDA has formally classified it, providing pharmacies, health systems, and patients with a clearer framework for responding. State and federal agencies typically use these notices to help distributors remove affected lots and prevent further dispensing.

Anyone who takes these medications should check the recall, review the batch number and expiration date, and contact their pharmacist, prescribing doctor, or health care provider for guidance if they have an affected product.

Get TCD's free newsletters for easy tips, smart advice, and a chance to earn $5,000 toward home upgrades. To see more stories like this one, change your Google preferences here.