FDA DrugsClass II
Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Tho...
Published: July 1, 2026Recall ID: D-0615-2026Category: drugsCountry: US
Reason for Recall / Hazard
Presence of Foreign Substance.
Product Description & Identification
Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC 55513-810-60
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 | Lot #: 1138203, 1142065, Exp. Date 07/31/2026; 1145151, 1145152, 1145153, Exp. Date 2/28/2027; 1148908, 1148909, Exp. Date 05/31/2027; 1162845, 1162846, Exp. Date 11/30/2027; 1166471, 1166472, 1166473, Exp. Date 05/31/2028; 1170615, Exp. Date 08/31/2028 |
| Postal code | 91320-1730 |
| Report date | 20260701 |
| Product type | Drugs |
| Product quantity | N/A |
| 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