Amgen Voluntarily Recalls Nearly 1 Million Bottles of Heart and Kidney Medications After Foreign Substance Found on Tablets

California-based Amgen, Inc. has voluntarily recalled 944,142 bottles of two prescription medications — Corlanor (ivabradine) and Sensipar (cinacalcet hydrochloride) — after unexpected foreign matter was found on tablets from one of its production lots.

The California State Board of Pharmacy issued an alert on the recall. The foreign substance was located on the exterior surface of the tablets, over the coating. It was not inside the tablets themselves. Amgen's investigation traced the contamination to the AML Building 23 packaging area at one of its facilities, and as a precaution the company pulled all lots within expiry that were processed in that space.

Who Uses These Drugs

Corlanor is prescribed to treat chronic heart failure. Sensipar is used primarily to manage overactive parathyroidism in patients with chronic kidney disease. Both patient populations tend to be medically vulnerable, which is why a recall of this scale draws attention even when the assessed risk is low.

The recalled tablets were distributed between October 28, 2021, and December 30, 2025 — a span of over four years. The recall covers three dosage strengths of Sensipar (30 mg, 60 mg, and 90 mg, each in 30-tablet bottles) and two bottle configurations of Corlanor 5 mg (14-tablet and 60-tablet bottles), across three National Drug Code numbers.

The Risk Assessment

According to the California State Board of Pharmacy, hazard assessments have concluded the foreign matter does not present a clinical risk to patients, and the overall patient safety risk is classified as low. As of the recall announcement, no complaints from patients or providers have been filed.

Amgen chose to pull the product rather than wait for complaints. That is standard practice under FDA voluntary recall protocols. The FDA's involvement and the California board's public alert confirm this is being handled through normal regulatory channels.

Heart failure and kidney disease patients are often elderly, immunocompromised, or on complex multi-drug regimens. Even a contaminant assessed as low-risk at the population level could theoretically affect a more sensitive individual. Critics of pharmaceutical self-regulation reasonably point out that companies conducting their own hazard assessments have an inherent interest in minimizing alarm. The California Board of Pharmacy's alert does not identify what the foreign substance actually was, which limits any independent verification of the low-risk conclusion.

The available facts show the substance was isolated to the exterior coating surface and did not penetrate the tablet. No adverse events have been reported across a distribution window spanning more than four years. The FDA and the California board, both independent of Amgen, have not escalated the classification beyond a precautionary voluntary recall.

What Patients Should Do

Anyone currently taking Corlanor or Sensipar should check whether their bottles fall under one of the recalled NDC numbers listed by the California State Board of Pharmacy. The specific codes are:

• Corlanor 5 mg, 60 tablets: NDC 55513-800-60
• Corlanor 5 mg, 14 tablets: NDC 55513-800-99
• Corlanor 5 mg, 60 tablets: NDC 55513-810-60
• Sensipar 30 mg, 30 tablets: NDC 55513-073-30
• Sensipar 60 mg, 30 tablets: NDC 55513-074-30
• Sensipar 90 mg, 30 tablets: NDC 55513-075-30

Neither Amgen nor the California board have publicly specified a return or disposal process in the available alert language. Patients on either medication — particularly those managing heart failure or kidney disease — should contact their prescribing physician or pharmacist before stopping or modifying their doses based on the recall, since abrupt discontinuation of either drug can carry its own medical risks.

Amgen has not publicly identified what the foreign substance was. Until that information is disclosed, neither patients nor independent reviewers can fully evaluate whether the low-risk classification is accurate.