HIGHFDA DRUG

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.

CORLANORAmgen IncHealth & Personal CareDrugs & Medicationsa) Lot # 1138901Exp. Date 08/31/20261149846

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
June 4, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
June 4, 2026
Hazard Level
HIGH
Brands
CORLANOR, Amgen Inc
Geographic Scope
1 states

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
CORLANOR, Amgen Inc
Model numbers
a) Lot # 1138901, Exp. Date 08/31/2026, 1149846, Exp. Date 04/30/2027 b) Lot #1138201, 1138202, 08/31/2026, 1138900, 1141143 +12 more
UPC codes
55513-800, 55513-810, 55513-813, 55513-800-60, 55513-800-99, 55513-810-60, 55513-813-01, 55513-813-28
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    June 4, 2026

  2. Reported by FDA DRUG

    July 1, 2026

  3. RecallRadar source check

    July 7, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Presence of Foreign Substance.

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Amgen, Inc. or your healthcare provider for guidance. Notification method: Letter

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Full Description

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.. Generic: IVABRADINE; Brand: CORLANOR. Reason: Presence of Foreign Substance.. Classification: Class II. Quantity: 934577 bottles. Distribution: Nationwide within the United States

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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