Amgen has voluntarily recalled specific lots of Corlanor (ivabradine) tablets nationwide after the FDA detected a foreign substance in some 5 mg and 7.5 mg packages produced in Italy. The recall—effective June 4—includes selected 14-tablet and 60-tablet bottles; the FDA classified it as a Class II recall on June 23. Patients taking Corlanor should check their lot numbers against the affected list and contact their doctor or pharmacist for replacement guidance. A separate recall of Sensipar (cinacalcet) for CGMP deviations was also noted by the FDA.
Amgen Issues Nationwide Recall of Corlanor (ivabradine) Tablets — Check Your Lot Number
Lilit Amirkhanian/Getty Images(Lilit Amirkhanian/Getty Images)
Amgen has initiated a voluntary nationwide recall of specific lots of Corlanor (ivabradine) tablets, the U.S. Food and Drug Administration (FDA) reported. The recall began on June 4 and affects certain 5 mg and 7.5 mg tablets manufactured in Italy after detection of a foreign substance in some packages.
What You Need To Know
Ivabradine (brand name Corlanor) is prescribed to help treat heart failure by lowering the heart rate and reducing the heart's workload. If you take Corlanor, check the lot number and expiration date on your bottle against the affected lots below and contact your prescriber or pharmacist immediately for guidance and replacement options.
Corlanor (ivabradine) 5 mg
Available in 14-tablet bottles (NDC 55513-800-99) and 60-tablet bottles (NDC 55513-800-60). All affected units were produced in Italy.
14-tablet bottles — Affected Lot Numbers and Expiration Dates
- Lot 1138901 — Exp. 08/31/2026
- Lot 1149846 — Exp. 04/30/2027
60-tablet bottles — Affected Lot Numbers and Expiration Dates
- Lots 1138201, 1138202 — Exp. 08/31/2026
- Lots 1138900, 1141143 — Exp. 08/31/2026
- Lots 1140280, 1140281, 1142063 — Exp. 10/31/2026
- Lots 1142062, 1142942, 1142943 — Exp. 11/30/2026
- Lots 1144081, 1144104 — Exp. 12/31/2026
- Lots 1146373, 1146374 — Exp. 01/31/2027
- Lots 1147491, 1147492, 1149843 — Exp. 03/31/2027
- Lots 1151113, 1151890, 1153401 — Exp. 07/31/2027
- Lots 1151114, 1151115 — Exp. 09/30/2027
- Lots 1152412, 1153399, 1153400 — Exp. 06/30/2027
- Lots 1155834, 1155835 — Exp. 04/30/2027
- Lot 1155836 — Exp. 09/30/2027
- Lots 1158480, 1158481, 1158482 — Exp. 10/31/2027
- Lots 1160354, 1160355 — Exp. 03/31/2028
- Lots 1161593, 1161594, 1161595 — Exp. 04/30/2028
- Lots 1164097, 1164098, 1164099 — Exp. 06/30/2028
- Lots 1165078, 1165079 — Exp. 07/31/2028
- Lot 1165080 — Exp. 02/29/2028
- Lots 1168005, 1168006, 1168007 — Exp. 09/30/2028
- Lots 1169288, 1169289 — Exp. 10/31/2028
- Lot 1172885 — Exp. 12/31/2028
Corlanor (ivabradine) 7.5 mg
Available only in 60-tablet bottles (NDC 55513-810-60). Affected lots include:
- Lots 1138203, 1142065 — Exp. 07/31/2026
- Lots 1145151, 1145152, 1145153 — Exp. 02/28/2027
- Lots 1148908, 1148909 — Exp. 05/31/2027
- Lots 1162845, 1162846 — Exp. 11/30/2027
- Lots 1166471, 1166472, 1166473 — Exp. 05/31/2028
- Lot 1170615 — Exp. 08/31/2028
FDA Classification And What It Means
On June 23 the FDA designated this a Class II recall, indicating that exposure may cause temporary or medically reversible health effects, or that serious adverse consequences are unlikely. Patients should not stop taking prescribed medication without first consulting their clinician.
Other Notes
The FDA notice also references a separate recall of Sensipar (cinacalcet) related to CGMP (current good manufacturing practice) deviations; that action is unrelated to the Corlanor foreign-substance recall. For the full FDA posting and the most up-to-date information, consult the FDA recall announcement or contact your pharmacy.
Action Steps: Check the lot number and expiration date on your Corlanor bottle against the lists above. If your lot is affected, contact your prescribing clinician or pharmacist immediately for instructions and replacement options.
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