FDA-Drug2026-07-01Class IIPROCESSING DEFECT

Amgen Corlanor (ivabradine) 5 mg tablets recalled for foreign substance contamination

Nationwide distribution

Amgen Corlanor heart medication recalled for foreign substance

Amgen has recalled multiple lots of Corlanor (ivabradine) 5 mg tablets due to the presence of a foreign substance in some bottles. The affected tablets are packaged in 14-tablet and 60-tablet bottles distributed nationwide. No injuries have been reported.

  • Check if your Corlanor matches one of the recalled lot numbers and expiration dates listed on the FDA website.
  • Contact your pharmacy or doctor if you have an affected bottle.
  • Do not use recalled tablets; return them to your pharmacy.
  • Continue taking your heart medication as prescribed — talk to your doctor about next steps if your supply is affected.
Hazard

Presence of Foreign Substance.

Sold states
Nationwide within the United States
Affected count
934577 bottles
Manufactured in
1 Amgen Center Dr, N/A, Thousand Oaks, CA, United States
Products
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.

Official notice

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

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