A Heart Medication Has Been Recalled Nationwide, Reports FDA

Amgen is a pharmaceutical manufacturer name you might recognize—and if you take this heart medication, it’s worth checking the details on your supply.

A new report from the U.S. Food and Drug Administration (FDA) shares that the Thousand Oaks, California offices of the company executed a voluntary nationwide recall, starting June 4, on two ivabradine medications by the brand name of Corlanor. (The Cleveland Clinic says ivabradine “treats heart failure. It works by decreasing your heart rate, which decreases the amount of work your heart has to do. This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.”)

Five-milligram and 7.5-milligram dosages of Corlanor tablets were recalled due to what the report calls “Presence of Foreign Substance.” No further details about the apparent issue are given.

The FDA report lists the following information for identifying recalled Corlanor. It says all were produced in Italy:

CORLANOR (ivabradine) 5 mg

Available in 14-tablet bottles (NDC 55513-800-99) or 60-tablet bottles (NDC 55513-800-60)

Check your lot number—if it appears on this list, your prescription is likely affected:

14-tablet bottles:

Affected lot numbers and expiration dates: Lot # 1138901, Exp. Date 08/31/2026; 1149846, Exp. Date 04/30/2027

60-tablet bottles:

Affected lot numbers and expiration dates: Lot #1138201, 1138202, 08/31/2026, 1138900, 1141143, Exp. Date 08/31/2026; 1140280, 1140281, 1142063, Exp. Date 10/31/2026; 1142062, 1142942, 1142943, Exp. Date 11/30/2026; 1144081, 1144104, Exp. Date 12/31/2026; 1146373, 1146374, Exp. Date 01/31/2027; 1147491, 1147492, 1149843, Exp. Date 03/31/2027; 1151113, 1151890, 1153401, Exp. Date 07/31/2027; 1151114, 1151115, Exp. Date 09/30/2027; 1152412, 1153399, 1153400, Exp. Date 06/30/2027; 1155834, 1155835, Exp. Date 04/30/2027; 1155836, Exp. Date 09/30/2027; 1158480, 1158481, 1158482, Exp. Date 10/31/2027; 1160354, 1160355, Exp. Date 03/31/2028; 1161593, 1161594, 1161595, Exp. Date 04/30/2028; 1164097, 1164098, 1164099, Exp. Date 06/30/2028; 1165078, 1165079, Exp Date 07/31/2028; 1165080, Exp. Date 02/29/2028;1168005, 1168006, 1168007, Exp. Date 09/30/2028; 1169288, 1169289, Exp. Date 10/31/2028; 1172885, Exp. Date 12/31/2028

CORLANOR (ivabradine) 7.5 mg

60-tablet bottles only (NDC 55513-810-60)

Affected lot numbers and expiration dates: Lot #: 1138203, 1142065, Exp. Date 07/31/2026; 1145151, 1145152, 1145153, Exp. Date 2/28/2027; 1148908, 1148909, Exp. Date 05/31/2027; 1162845, 1162846, Exp. Date 11/30/2027; 1166471, 1166472, 1166473, Exp. Date 05/31/2028; 1170615, Exp. Date 08/31/2028

As with most prescriptions, it’s advisable to reach out to your doctor or a pharmacist immediately to inquire about a replacement product.

On June 23, the FDA named this a Class II recall, suggesting exposure “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

Interestingly, the report also lists another medication, Sensipar (cinacalcet), which the Cleveland Clinic says is prescribed to help treat “chronic kidney disease (dialysis) and high levels of calcium in your blood if you have parathyroid gland conditions.” The Sensipar is being recalled for a separate reason (CGMP Deviations), and additional details can be found at the above FDA link.

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