The tablets involved in the recall were distributed in the U.S. from Oct. 28, 2021, to Dec. 30, 2025
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NEED TO KNOW
- A pharmaceutical company has recalled more than 900,000 bottles of prescription heart and kidney medications
- Amgen, Inc. shared that several different forms of tablets of Corlanor and Sensipar were recalled after “an unexpected foreign matter” was found in some bottles
- The tablets involved in the recall were distributed in the U.S. from Oct. 28, 2021, to Dec. 30, 2025
A pharmaceutical company has recalled more than 900,000 bottles of prescription heart and kidney medications after reports of "unexpected foreign matter" in some of the bottles.
In a recall announcement shared by the California State Board of Pharmacy, Amgen, Inc. initiated the recall after several different types of Corlanor and Sensipar tablets were found to have been contaminated with an "unexpected foreign matter." The company said that it recalled the tablets after informing the Food and Drug Administration (FDA).
"The unexpected foreign matter was localized on the exterior tablet surface, over the coating," the Thousand Oaks, Calif.-based company wrote in its announcement. "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."
Credit: Mario Tama/Getty
Corlanor, also known by the generic name ivabradine, is used to treat adults who have chronic heart failure to reduce their risk of hospitalization for worsening heart failure, per the Mayo Clinic.
Sensipar, which is also sold under the generic name cinacalcet hydrochloride, is prescribed to patients with chronic kidney disease and high levels of calcium in the blood related to parathyroid gland conditions, according to the Cleveland Clinic.
The company initiated the recall following inspection of a "reserve sample," at which time the "unexpected foreign matter" was identified in a "small number of units," an Amgen spokesperson told PEOPLE in a statement.
"As a precaution, Amgen is voluntarily recalling all lots of Corlanor® and Sensipar® Tablets within expiry from retail pharmacies in the United States," the spokesperson said. "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."
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The tablets involved in the recall were distributed in the U.S. from Oct. 28, 2021, to December 30, 2025.
Lot numbers include 1156858, 1157055 and 1157056, and expiration dates range from December 2027 to February 2028.
Amgen shared that the recalled Corlanor came in two forms — 5 mg tablets with 60 tablets per bottle and 5 mg tablets with 14 tablets per bottle. The tablets were labeled with more than two dozen lot numbers and expiration dates ranging from July 2026 to December 2028.
The recalled Sensipar tablets came in the form of 30 mg tablets with 30 tablets in 1 bottle; 60 mg tablets with 30 tablets per bottle; and 90 mg tablets with 30 tablets per bottle.
Patients can view the full list of recalled lots on the FDA website.
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