Recall: D-0612-2026

Class II - Potentially Harmful

Class IIClassification

2026-06-04Initiated

OngoingStatus

Amgen, Inc.Firm

Product

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

Presence of Foreign Substance.

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.