Amgen has voluntarily recalled nearly one million bottles of its heart medication Corlanor (ivabradine) after the possible presence of a foreign substance was identified. According to U.S. Food and Drug Administration records, the company initiated the nationwide recall on June 4, 2026, and the agency classified it as a Class II recall on June 23.
The FDA issued two separate recall notices covering Corlanor. One notice applies to 934,577 bottles of the 5 mg tablets packaged in both 14-count and 60-count containers. A second notice covers an undisclosed number of 7.5 mg tablets packaged in 60-count bottles. According to the FDA, all of the affected Corlanor products were manufactured in Italy.
Corlanor Recall Affects Multiple Lots Distributed Across the United States
Corlanor is prescribed to treat chronic heart failure in adults and is also indicated for children aged six months or older with stable heart failure symptoms caused by an enlarged heart. The FDA classified the recall as a Class II action, a designation used for situations in which exposure to a recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is considered remote.
According to the FDA recall listing, the affected 7.5 mg, 60-count bottles carry National Drug Code 55513-810-60 and include lots 1138203 and 1142065 with an expiration date of July 31, 2026; lots 1145151, 1145152, and 1145153 expiring February 28, 2027; lots 1148908 and 1148909 expiring May 31, 2027; lots 1162845 and 1162846 expiring November 30, 2027; lots 1166471, 1166472, and 1166473 expiring May 31, 2028; and lot 1170615 expiring August 31, 2028. The FDA lists the recall as ongoing, with distribution taking place nationwide within the United States. No press release was issued for the recall.
Separate Sensipar Recalls Announced as Amgen Faces Additional Regulatory Developments
Amgen also initiated a nationwide recall involving 9,565 bottles of Sensipar (cinacalcet) 30 mg tablets packaged in 30-count bottles. The medication is used to treat hyperparathyroidism in dialysis patients as well as elevated blood calcium associated with parathyroid cancer or severe primary hyperparathyroidism.
According to FDA records, the company also recalled an undisclosed number of Sensipar 60 mg and 90 mg tablets packaged in 30-count bottles because of manufacturing deviations. Those recalls were also classified as Class II actions, and all of the recalled Sensipar tablets were manufactured in Japan. The FDA records show the recall dates posted for Sensipar are the same as those for Corlanor.
The recalls come as Amgen also faces regulatory developments involving Tavneos, a treatment for ANCA-associated vasculitis. According to the reported information, European Union regulators recommended that the drug lose its marketing authorization after a review concluded that its benefits were no longer proven to outweigh its risks. A final decision from the European Commission was expected soon, while the company was also preparing for an FDA hearing addressing efficacy and safety concerns related to the same medicine.
