Corlanor — Class II drug recall D-0612-2026
Ongoing recall by Amgen, Inc., reported 2026-07-01, distributed nationwide. Presence of Foreign Substance.
| Recall number | D-0612-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amgen, Inc., Thousand Oaks, CA, United States |
| Recall initiated | 2026-06-04 |
| Classified | 2026-06-23 |
| Reported by FDA | 2026-07-01 |
| Distributed | Nationwide (US) |
| Quantity | 934,577 bottles |
| NDC | 55513-0800, 55513-0800-60, 55513-0800-99, 55513-0810, 55513-0810-60, 55513-0813, 55513-0813-01, 55513-0813-28 |
| Lot numbers | 1138201, 1138202, 1138900, 1138901, 1140280, 1140281, 1141143, 1142062, 1142063, 1142942, 1142943, 1144081, 1144104, 1146373, 1146374, 1147491, 1147492, 1149843, 1149846, 1151113, 1151114, 1151115, 1151890, 1152412, 1153399, 1153400, 1153401, 1155834, 1155835, 1155836, 1158480, 1158481, 1158482, 1160354, 1160355, 1161593, 1161594, 1161595, 1164097, 1164098 and 10 more |
| Expiration dates | 2026-08-31, 2026-10-31, 2026-11-30, 2026-12-31, 2027-01-31, 2027-03-31, 2027-04-30, 2027-06-30, 2027-07-31, 2027-09-30, 2027-10-31, 2028-02-29, 2028-03-31, 2028-04-30, 2028-06-30, 2028-07-31, 2028-09-30, 2028-10-31, 2028-12-31 |
Product
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 for recall
Presence of Foreign Substance.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0612-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.