Amgen Recalls Corlanor 7.5mg Tablets Due to Foreign Substance
Amgen recalls 7.5mg Corlanor tablets with foreign substance. Affected lots expire through 2028. No remedy specified in recall notice.
Recall notice
Presence of Foreign Substance.
Contact the company
What happened, in plain English
Amgen is recalling 7.5mg Corlanor (ivabradine) tablets that may contain a foreign substance. This recall affects specific lots of the medication, which were manufactured in Italy and expire through 2028. The presence of a foreign substance could pose a risk to users. Read more at govinfonow.com/recall/31219-amgen-recalls-corlanor-7-5mg-tablets-due-to-foreign-substance.
Source Summary by GovInfoNow · govinfonow.com/recall/31219-amgen-recalls-corlanor-7-5mg-tablets-due-to-foreign-substance · Updated August 10, 2026 · FDA enforcement record: FDA #D-0615-2026
Cite this page
“Amgen Recalls Corlanor 7.5mg Tablets Due to Foreign Substance.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/31219-amgen-recalls-corlanor-7-5mg-tablets-due-to-foreign-substance. Based on FDA recall #D-0615-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0615-2026%22&limit=1).
Why it’s dangerous
The recall states that the tablets may contain a foreign substance. While the exact nature of the foreign substance isn't specified, it could potentially cause harm when taken as directed. This is a medication recall for safety reasons.
Who’s affected
Prescription medication users who have the specific lots of Corlanor tablets listed in the recall. Patients with heart conditions requiring ivabradine therapy are most at risk.
How to tell if you have this one
Check the product label for the NDC code 55513-810-60 and lot numbers listed: 1138203, 1142065, 1145151-1145153, 1148908-1148909, 1162845-1162846, 1166471-1166473, 1170615. The tablets are prescription-only and expire through 2028.
- Brand
Amgen- Category
Drug
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Nationwide within the United States
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0612-2026 | 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.; 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. | 934577 bottles | 55513-800-60, 55513-800-99, 55513-810-60, 55513-813-01, 55513-813-28 |
| D-0613-2026 | Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-073-30; Lot#: 1156858, Exp. Date 12/31/2027. | 9565 bottles | 55513-073-30, 55513-074-30, 55513-075-30 |
| D-0614-2026 | Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-074-30; Lot #: 1157055, Exp. Date 1/31/2028 | N/A | 55513-073-30, 55513-074-30, 55513-075-30 |
| D-0615-2026 | Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC 55513-810-60; 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 | N/A | 55513-800-60, 55513-800-99, 55513-810-60, 55513-813-01, 55513-813-28 |
| D-0616-2026 | Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks, CA 91320-1799, Made in Japan. NDC 55513-075-30; Lot #: 1157056, Exp. Date 02/29/2028 | N/A | 55513-073-30, 55513-074-30, 55513-075-30 |
What to do — step by step
Check Product Label
Look for the NDC code 55513-810-60 and lot numbers listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 27 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0615-2026 (June 4, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0615-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.