FDA RECALL: Class II Recall Issued for Corlanor Heart‑Failure Meds

A nationwide Class II recall has been issued for Corlanor (ivabradine), a prescription medication used to treat chronic heart failure, after routine quality checks identified a foreign substance on certain tablets.

FDA RECALL:  Amgen recall affects more than 944,000 bottles distributed across the United States.

Impacted products include:

• Corlanor 5 mg — 14‑count and 60‑count bottles
• Corlanor 7.5 mg — 60‑count bottles
• Multiple lot numbers manufactured and shipped nationwide

The FDA classified the action as Class II, meaning exposure could cause temporary or medically reversible health effects, but the likelihood of serious injury is considered low.

Patients should not stop taking Corlanor abruptly, as ivabradine directly affects heart rhythm.

The FDA advises checking the NDC and lot number on the bottle and contacting a pharmacist or prescriber for guidance if the product matches a recalled lot.

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