According to the Food and Drug Administration (FDA), nearly one million bottles of a medication used to reduce the risk of hospitalization in patients with heart failure have been recalled.

California-based Amgen, Inc. voluntarily recalled at least 944,142 bottles of Corlanor and Sensipar tablets after “unexpected foreign matter” was found “in the reserve sample of one of the identified lots,” an alert read.

The Hill shared further:

The recalled medication includes 5 mg Corlanor (ivabradine) tablets provided in both 14-tablet and 60-tablet bottles by prescription only. An undisclosed number of 7.5 mg tablets sold in 60-tablet bottles was also included in the recall, the FDA indicated.

Lot codes and expiration dates for each type of bottle can be found in the agency’s enforcement report.

A spokesperson for Amgen, Inc. said the company discontinued the medication and that only a limited amount of product is expected to remain in retail distribution.

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The recall, which was initiated on June 4, has since been categorized as a Class II recall, meaning that use or exposure to the medication may cause temporary or reversible adverse health effects, according to the FDA.

“The unexpected foreign matter was localized on the exterior tablet surface, over the coating,” the California state Board of Pharmacy said, according to Fox Business.

“Therefore, as a precautionary measure, all lots within expiry that were processed in AML Building 23 packaging area, where the condition occurred, are being recalled,” it continued.

Fox Business has more:

The board added that hazard assessments have found it doesn’t present a clinical risk to patients and “overall patient safety risk is low.”

There have been no complaints about the issue.

Corlanor, which is also known by the generic name ivabradine, is prescribed to treat patients with chronic heart failure and Sensipar, also known as cinacalcet hydrochloride, is mainly used to treat overactive parathyroidism in chronic kidney disease patients.

The tablets were distributed between Oct. 28, 2021 and Dec. 30, 2025.

The recall includes the following presentations, according to the board:

  • Corlanor® (ivabradine) 5 mg, 60 tablets in 1 bottle; NDC 55513-800-60
  • Corlanor® (ivabradine) 5 mg, 14 tablets in 1 bottle; NDC 55513-800-99
  • Corlanor® (ivabradine) 5 mg, 60 tablets in 1 bottle; NDC 55513-810-60
  • Sensipar® (cinacalcet hydrochloride) 30 mg, 30 tablets in 1 bottle; NDC 55513-073- 30
  • Sensipar® (cinacalcet hydrochloride) 60 mg, 30 tablets in 1 bottle; NDC 55513-074- 30
  • Sensipar® (cinacalcet hydrochloride) 90 mg, 30 tablets in 1 bottle; NDC 55513-075- 30
 

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