⚠ Data freshness notice: the most recent refresh of NHTSA was incomplete, so a
very recent recall may be missing. Everything shown is accurate as of the last checked time on this page —
for anything time-critical, confirm with the official sources linked below.
FDAClass II · Drug · Recalled July 1, 2026
Corlanor (ivabradine) tablets recall — Amgen, Inc.
Hazard: Presence of Foreign Substance.
Class II: may cause temporary or medically reversible health consequences.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- D-0612-2026
- Brand
- Amgen
- Classification
- Class II
- Units affected
- 934577 bottles
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
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.
Affected products
Companies & origin
- Recalling firm location
- Thousand Oaks, CA, United States
- Firm address
- 1 Amgen Center Dr, N/A, 91320-1730
Identifying details (verbatim from the notice)
- Product codes / lots
- 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.
- Distribution
- Nationwide within the United States
- Firm notified the public via
- Letter
- FDA event ID
- 99077
- Recall initiated
- June 4, 2026
- FDA classified
- June 23, 2026
- FDA report date
- July 1, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.
Report a data error on this page