Nearly 1 million bottles of heart and kidney medication recalled over foreign substance
The FDA has characterized the medication recall as Class II. (Sarah Silbiger/Getty Images, File)
Nearly one million bottles of heart and kidney medication have been recalled nationwide over the possibility of a "foreign substance," according to the U.S. Food and Drug Administration.
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," the California state Board of Pharmacy said in an alert.
"The unexpected foreign matter was localized on the exterior tablet surface, over the coating," the board said. "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."
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.
Amgen's headquarters in Thousand Oaks, Calif. (Paul Harris/Getty Images, File)
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
The FDA has characterized the recall as Class II, meaning it could "cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."