FDA-Drug2026-07-01Class IIPACKAGING DEFECT

Amgen Corlanor (ivabradine) 7.5mg tablets recalled for foreign substance

Nationwide distributionDrugs

What this means

Amgen is recalling specific lots of Corlanor (ivabradine) 7.5mg tablets due to the presence of a foreign substance in some bottles. The affected lots were distributed nationwide. No injuries have been reported.

  • Check if your Corlanor matches one of the recalled lot numbers (1138203, 1142065, 1145151, 1145152, 1145153, 1148908, 1148909, 1162845, 1162846, 1166471, 1166472, 1166473, or 1170615).
  • Contact your pharmacist or doctor if you have a recalled lot; do not stop taking your medication without medical guidance.
  • Return the recalled bottles to your pharmacy.
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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
N/A
Manufactured in
1 Amgen Center Dr, N/A, Thousand Oaks, CA, United States
Products
Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC 55513-810-60

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0615-2026

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