FDA DrugsClass II
Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 5551...
Published: July 1, 2026Recall ID: D-0612-2026Category: drugsCountry: US
Reason for Recall / Hazard
Presence of Foreign Substance.
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Thousand Oaks |
| State | CA |
| Openfda › Upc › 1 | 0355513800600 |
| Openfda › Upc › 2 | 0355513810609 |
| Openfda › Unii | TP19837BZK |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 1649485 |
| Openfda › Rxcui › 2 | 1649491 |
| Openfda › Rxcui › 3 | 1649493 |
| Openfda › Rxcui › 4 | 1649495 |
| Openfda › Rxcui › 5 | 2168592 |
| Openfda › Rxcui › 6 | 2168596 |
| Openfda › Spl id | 8ab000cd-0258-489a-b1bb-4cc1ca359d6c |
| Openfda › Brand name | CORLANOR |
| Openfda › Spl set id | 92018a65-38f6-45f7-91d4-a34921b81d0d |
| Openfda › Package ndc › 1 | 55513-800-60 |
| Openfda › Package ndc › 2 | 55513-800-99 |
| Openfda › Package ndc › 3 | 55513-810-60 |
| Openfda › Package ndc › 4 | 55513-813-01 |
| Openfda › Package ndc › 5 | 55513-813-28 |
| Openfda › Product ndc › 1 | 55513-800 |
| Openfda › Product ndc › 2 | 55513-810 |
| Openfda › Product ndc › 3 | 55513-813 |
| Openfda › Generic name | IVABRADINE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | IVABRADINE HYDROCHLORIDE |
| Openfda › Manufacturer name | Amgen Inc |
| Openfda › Application number | NDA206143 |
| Openfda › Is original packager | true |
| Event id | 99077 |
| Address 1 | 1 Amgen Center Dr |
| Address 2 | N/A |
| Code info | 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. |
| Postal code | 91320-1730 |
| Report date | 20260701 |
| Product type | Drugs |
| Product quantity | 934577 bottles |
| Reason for recall | Presence of Foreign Substance. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260604 |
| Initial firm notification | Letter |
| Center classification date | 20260623 |
Overview
- Recalling FirmAmgen, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide within the United States