Warning
Amgen Recalls Corlanor (ivabradine) tablets
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0612-2026Drug / Pharmaceutical
Amgen Recalls Corlanor (ivabradine) tablets
Amgen, Inc. · Class II — Moderate Risk
Product 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.
Reason for Recall
Presence of Foreign Substance.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Nationwide within the United States
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
A Class II FDA recall has been issued for a pharmaceutical product from Amgen, Inc., initiated on June 4, 2026. Presence of Foreign Substance. This recall covers 934577 bottles, distributed nationwide. While not the highest severity, consumers should exercise caution and stop using the product until the recall is resolved.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.