Amgen Recalls Corlanor 7.5mg Tablets Due to Foreign Substance

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Recalling firmAmgen, Inc.1 Amgen Center Dr, N/A · Thousand Oaks, CA 91320-1730

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✎ GovInfoNow plain-language explainer

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.

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

Based on the official FDA remedy

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.

✎ GovInfoNow

Questions people ask

Is this medication safe to use?

The recall states that the tablets may contain a foreign substance, so they are not safe to use as recalled. No remedy is specified in the notice.

What should I do if I have the recalled product?

The recall does not specify a remedy, so you should contact Amgen directly for guidance.

How can I tell if I have the recalled product?

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.

Take action

Contact Amgen

We’ve drafted a message you can send Amgen to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall D-0615-2026 — Amgen Amgen

Hello,

I own a Amgen that is covered by recall D-0615-2026 from Amgen.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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.

Amgen, Inc. recalls Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC

Recall notice