CLASS II ONGOING Drug recall · Reported 1 Jul 2026 · FDA Enforcement Report
Corlanor (ivabradine) tablets, 7.5mg recalled by Amgen
Amgen is recalling Corlanor (ivabradine) tablets, 7.5mg, distributed nationwide in the US. The recall was initiated on 4 Jun 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0615-2026
- FDA event ID
- 99077
- Recalling firm
- Amgen, Thousand Oaks, CA
- Brand
- Corlanor
- Manufacturer
- Amgen Inc
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Jun 2026
- FDA classified
- 23 Jun 2026
- Reported
- 1 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 4 Jun 2026 | Recall initiated by company | |
| 23 Jun 2026 | Classified by FDA | +19 days |
| 1 Jul 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance.
Product as listed by the FDA
Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC 55513-810-60
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Presence of Foreign Substance.
Which lots are affected?
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
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 99077| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Corlanor (ivabradine) tablets, 5 mg recalled by AmgenCorlanor | Amgen | Packaging Defects | Nationwide | |
| CLASS II | Sensipar (cinacalcet) Tablets, 60mg recalled by AmgenSensipar | Amgen | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Sensipar (cinacalcet) Tablets, 90mg recalled by AmgenSensipar | Amgen | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Sensipar (cinacalcet) Tablets, 30mg recalled by AmgenSensipar | Amgen | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Amgen
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sensipar (cinacalcet) Tablets, 30mg recalled by AmgenSensipar | Amgen | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Sensipar (cinacalcet) Tablets, 90mg recalled by AmgenSensipar | Amgen | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Sensipar (cinacalcet) Tablets, 60mg recalled by AmgenSensipar | Amgen | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Corlanor (ivabradine) tablets, 5 mg recalled by AmgenCorlanor | Amgen | Packaging Defects | Nationwide |
| Drug | CLASS II | Neupogen (filgrastim) For Injection, 480 mcg recalled by AmgenNeupogen | Amgen | Potency & Assay | Nationwide |
Other Ivabradine recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Corlanor (ivabradine) tablets, 5 mg recalled by AmgenCorlanor | Amgen | Packaging Defects | Nationwide |