Amgen Recalls Nearly 1 Million Bottles of Corlanor and Sensipar Over Foreign Matter Contamination
核心洞察
Amgen has voluntarily recalled approximately 944,000 bottles of heart failure drug Corlanor (ivabradine) (搜索) and kidney disease drug Sensipar (cinacalcet hydrochloride) (搜索) after unexpected foreign matter was discovered on tablet surfaces.
The foreign material was localized on the exterior coating of tablets and was identified during inspection of a reserve sample from one of the affected lots.
The FDA has classified the recall as Class II, indicating a low probability of serious adverse health consequences, and no patient complaints have been reported.
Amgen, Inc. has initiated a voluntary nationwide recall of more than 900,000 bottles of its prescription heart and kidney medications after an inspection revealed "unexpected foreign matter" on the surface of some tablets. The recall, announced by the California State Board of Pharmacy, encompasses multiple formulations of Corlanor (ivabradine) (搜索) and Sensipar (cinacalcet hydrochloride) (搜索).
According to the recall announcement, the contamination was discovered during an inspection of a "reserve sample" from one of the identified lots. "The unexpected foreign matter was localized on the exterior tablet surface, over the coating," the Thousand Oaks, California-based company stated. "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 recall covers approximately 944,142 bottles distributed across the United States between October 28, 2021, and December 30, 2025. The FDA has classified the action as a Class II recall, which the agency defines as a situation where "use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."
Medications Affected
Corlanor, known generically as ivabradine, is prescribed to adults with chronic heart failure (搜索) to reduce the risk of hospitalization for worsening heart failure. Sensipar (cinacalcet hydrochloride) (搜索) is used in patients with chronic kidney disease (搜索) who have high levels of calcium in the blood related to parathyroid gland conditions.
The recalled Corlanor products include 5 mg tablets in bottles of 60 and 14 tablets, with more than two dozen lot numbers and expiration dates ranging from July 2026 to December 2028. The Sensipar recall involves 30 mg, 60 mg, and 90 mg tablets, each packaged with 30 tablets per bottle.
Risk Assessment and Company Response
An Amgen spokesperson told PEOPLE that the foreign matter was identified in a "small number of units" and emphasized the precautionary nature of the recall. "While Amgen has determined that the presence of the foreign matter represents a low potential health risk to patients, some tablets may not meet internal quality standards for appearance," the spokesperson said.
The California State Board of Pharmacy noted that hazard assessments have found the contamination does not present a clinical risk to patients and that "overall patient safety risk is low." No complaints related to the issue have been reported to date.
Patients currently taking Corlanor or Sensipar can consult the full list of recalled lot numbers on the FDA website. The specific lot numbers identified include 1156858, 1157055, and 1157056, with expiration dates ranging from December 2027 to February 2028.