Corlanor recall (Amgen, Inc.)
DrugClass IIOngoing
Summary: Amgen, Inc. is recalling Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99), and b) 60 tablet bottles (NDC 55513-800-60), Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy.. Reason: Presence of Foreign Substance.
What is being recalled
Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99), and b) 60 tablet bottles (NDC 55513-800-60), Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy.
Why
Presence of Foreign Substance.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide within the United States
How to tell if yours is affected
a) Lot # 1138901, Exp. Date 08/31/2026; 1149846, Exp. Date 04/30/2027 b) 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.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0612-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 4, 2026 |
| Reported | July 1, 2026 |
| Company | Amgen, Inc. |
| Company location | Thousand Oaks, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 934577 bottles |
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