A California-based drug company said it is recalling hundreds of thousands of bottles of heart, kidney, and thyroid medications, according to the notice published by the Food and Drug Administration (FDA) this week.
Amgen is recalling more than 900,000 bottles of Corlanor and Sensipar medications across the United States due to the “presence of [a] foreign substance” and “CGMP deviations,” according to the notice. The FDA says CGMP deviations occur when a company does not follow “current good manufacturing practices” when the drug or product is made.
The FDA on June 23 classified the recall as Class II, or what the agency said is “a situation in which 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.” The drugs were recalled on June 4 by Amgen.
In a separate notice published by the California Board of Pharmacy, the company recalled the medications due to “a low frequency event of an unexpected foreign matter in the reserve sample of one of the identified lots.”
“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 notice said, adding that “medical impact and physical hazard associated with the identified foreign material do not pose a clinical risk to patients, and the overall patient safety risk is low.”
It added that the company has not received any reports of complaints associated with this product. Neither the FDA nor the California agency provided details on the foreign substance or the current good manufacturing practices that were not followed.
Sensipar, or cinacalcet, is a prescription drug that lowers parathyroid hormone, calcium, and phosphorus levels in the blood, according to the National Library of Medicine. It can be used for patients with chronic kidney disease, people on dialysis, and people with parathyroid cancer, among other conditions.
Corlanor, or ivabradine, is a prescription medication that can be taken to lower the heart rate without causing blood pressure to also decline, according to the Mayo Clinic.
List of Medications Under Recall
Several dozen lots of Corlanor and Sensipar are under recall across the United States. They were distributed between Oct. 28, 2021, and Dec. 30, 2025.
Corlanor (ivabradine) 5-milligram tablets, 14-count bottles with the NDC 55513-800-99, made in Italy.
Corlanor (ivabradine) 5-milligram tablets, 60-count bottles with the NDC 55513-800-60 1138201, made in Italy
Corlanor (ivabradine) 7.5-milligram tablets, 60-count bottles with the NDC 55513-810-60, made in Italy
Sensipar (cinacalcet) 30-milligram tablets, 30-count bottles with the NDC 55513-073-30, made in Japan
Sensipar (cinacalcet) 60-milligram tablets, 30-count bottles with the NDC 55513-074-30, made in Japan
Sensipar (cinacalcet) 90-milligram tablets, 30-count bottles, with the NDC 55513-075-30, made in Japan
A full list of the recalled products’ lots and expiration dates can be accessed via the FDA’s website.
The recall notices from either the California board or the FDA did not say whether people should stop taking the medications. No press release was issued by the manufacturer.
No other medications are included in the recall. People with questions can contact the FDA by calling its number, 1-888-INFO-FDA.
