Pharmaceutical workers inspect recalled medication bottles on a production line.
Amgen, Inc. has initiated a voluntary recall affecting nearly one million bottles of its heart and kidney medications, Corlanor and Sensipar. The recall was prompted by the discovery of unexpected foreign matter on the surface of the tablets during routine sampling.
The issue was identified in the reserve sample of one of the affected lots. While the foreign matter was localized on the exterior coating of the tablets, Amgen is recalling all lots within their expiry date that were processed in the specific packaging area where the condition occurred as a precautionary measure.
According to the California state Board of Pharmacy, hazard assessments have indicated that the foreign matter does not present a significant clinical risk to patients, and the overall patient safety risk is considered low. No complaints related to this issue have been reported.
Corlanor (generic name: ivabradine) is prescribed for patients with chronic heart failure. Sensipar (generic name: cinacalcet hydrochloride) is primarily used to treat overactive parathyroidism in individuals with chronic kidney disease.
The recalled medications were distributed between October 28, 2021, and December 30, 2025. The U.S. Food and Drug Administration (FDA) has classified this recall as Class II, signifying that the affected products could cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote.
The recall includes specific presentations of Corlanor and Sensipar, detailed by their respective National Drug Codes (NDCs):
- 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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