FDA recall D-0612-2026

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 for recall

Presence of Foreign Substance.

Distribution

Nationwide within the United States

Key facts

Status

Ongoing

Initiation date

2026-06-04

Report date

2026-07-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Thousand Oaks, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0612-2026