A significant recall has been initiated by Amgen, Inc., affecting over 900,000 bottles of heart and kidney medications distributed across the United States. The decision follows the discovery of “unexpected foreign matter” in certain batches of the company’s Corlanor and Sensipar tablets.
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The recall was officially announced by the California State Board of Pharmacy, which revealed that the recall includes several varieties of these prescription medications. The contamination was identified during an inspection of a reserve sample, leading Amgen to take precautionary measures by notifying the Food and Drug Administration (FDA) and issuing the recall.
Amgen explained that the foreign matter was detected on the exterior surface of the tablets, specifically located over the coating. To ensure patient safety, the company called for the recall of all lots still within their expiry date that were processed in a specific packaging area where the contamination issue emerged.
Corlanor, generically named ivabradine, is primarily prescribed for adults suffering from chronic heart failure. The medication aims to decrease the risk of hospitalisation due to worsening heart failure. In parallel, Sensipar, known as cinacalcet hydrochloride, is administered to individuals with chronic kidney disease who have elevated calcium levels in the blood linked to conditions of the parathyroid gland.
Despite the low risk presented by the presence of this foreign matter, which may not conform to Amgen’s stringent internal quality standards, the company prioritised patient safety. An Amgen spokesperson stated that while the contamination poses a minimal health risk, the products do not meet the company’s quality expectations regarding appearance.
The recalled tablets were distributed between 28 October 2021 and 30 December 2025, encompassing lot numbers such as 1156858, 1157055, and 1157056, with expiry dates ranging from December 2027 to February 2028. The Corlanor tablets are available in two presentations: 5 mg tablets, sold with 60 tablets per bottle, and 5 mg tablets in bottles containing 14 tablets. Each of these products bears a distinct set of lot numbers with expiration dates extending to between July 2026 and December 2028.
Additionally, Sensipar tablets were affected, available in various strengths: 30 mg tablets in bottles of 30, 60 mg tablets in similar packaging, and 90 mg tablets also containing 30 tablets per bottle.
Patients who may have purchased these medications are urged to check the lot numbers and expiry dates to ensure their products are not affected by the recall. A complete list of the recalled tablet lots can be accessed through the FDA’s official website.
As this situation unfolds, authorities stress the importance of patient awareness regarding medication safety and quality. Amgen’s proactive approach in recalling its products showcases a commitment to maintaining rigorous quality controls and prioritising healthcare outcomes for patients reliant on these essential medicines.