FDA-Drug2026-07-01Class IIPROCESSING DEFECT
Amgen Corlanor (ivabradine) 5 mg tablets recalled for foreign substance contamination
Nationwide distributionDrugs
What this means
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.
The agency's original wording
Hazard
Presence of Foreign Substance.
Intended for
Adults
Illnesses reported
None reported
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-0612-2026Want us to check the next one for you?
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