FDA Drug recall D-0615-2026
Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy
- FDA Drug
- Class II
- ongoing
- Published 2026-07-01
On 2026-07-01 the FDA classified a Class II recall of Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy by Amgen, citing presence of Foreign Substance.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0615-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-04 |
| Published | 2026-07-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Amgen |
| Distribution | US |
Product
Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC 55513-810-60
Reason
Presence of Foreign Substance.
Identifiers
| ndc | 55513-800-60 |
|---|---|
| ndc | 55513-800-99 |
| ndc | 55513-810-60 |
| ndc | 55513-813-01 |
| ndc | 55513-813-28 |
| code_info | Lot #: 1138203, 1142065, Exp. Date 07/31/2026; 1145151, 1145152, 1145153, Exp. Date 2/28/2027; 1148908, 1148909, Exp. D…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 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by Amgen
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FDA Drug · Class II · 2026-07-01 · Amgen - Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799,…
FDA Drug · Class II · 2026-07-01 · Amgen - Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799,…
FDA Drug · Class II · 2026-07-01 · Amgen - 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…
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FDA Drug · Class II · 2025-03-26 · Amgen
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0615-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.