Nearly 1 Million Bottles of Heart and Kidney Medication Recalled over Foreign Substance
Amgen recalled 944,142 bottles after unexpected foreign matter was found in one lot, and the Food and Drug Administration classified the action as Class II.
- California-Based Amgen voluntarily recalled nearly 1 million bottles of Corlanor and Sensipar tablets nationwide after detecting "unexpected foreign matter" in a reserve sample of one identified lot.
- The company pulled all lots processed in AML Building 23 packaging area as a precautionary measure after the foreign matter was found on tablet exteriors during quality checks.
- At least 944,142 bottles of the heart and kidney medications are affected, with the FDA classifying the recall as Class II, meaning it could "cause temporary or medically reversible adverse health consequences."
- Hazard assessments indicate "overall patient safety risk is low," the California Board of Pharmacy said, and authorities have received no complaints regarding the affected tablets to date.
- The affected tablets were distributed between October 28, 2021, and December 30, 2025, spanning nearly four years of supply as Amgen manages the nationwide logistics of the voluntary return.
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NBC Chicago
NBC Dallas-Fort WorthWidely used heart, kidney medications recalled due to 'foreign substance'
Nearly one million bottles of common heart and kidney prescription medication have been voluntarily recalled due to “presence of a foreign substance,” according to a Food and Drug enforcement report. The recall was issued by California drugmaker Amgen June 4, the report said. In total, more than 944,000 bottles were recalled, with the prescription pills distributed to patients nationwide. One of the medications recalled was Coloranor (generic na…
Nearly 1 million bottles of heart and kidney medication recalled over foreign substance
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.
Fox Business
Nearly 1 million bottles of heart and kidney medication recalled over foreign substance found on tablets
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.…
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