Why This Matters
If you or a family member takes Corlanor for heart failure, it is time to check the lot number on your bottle.
Amgen, Inc. initiated a voluntary nationwide recall of at least 934,577 bottles of Corlanor (ivabradine) tablets on June 4, 2026, after quality inspection identified unexpected foreign matter on the exterior coating surface of tablets in a reserve sample from one of the affected production lots. The U.S. Food and Drug Administration classified the recall as Class II on June 23, 2026, meaning that while the probability of serious adverse health consequences is low, some exposure to the foreign substance could result in temporary or medically reversible adverse health effects.
The recall covers 5 mg and 7.5 mg tablets manufactured in Italy, distributed across the United States in 14-tablet and 60-tablet bottles. Expiration dates on affected lots range from July 2026 through December 2028, meaning some affected bottles are still within their expiration window and still in patients' homes.
What We Know So Far
Amgen confirmed that the foreign matter was identified in the exterior coating of tablets during inspection of a reserve sample from one affected production lot. The substance was localized on the outer coating surface, not within the tablet core. An Amgen spokesperson told multiple outlets that the company "determined that the presence of the foreign matter represents a low potential health risk to patients," though some tablets may not meet internal quality standards for appearance.
No patient complaints or adverse events attributed to the recalled lots had been reported at the time of the recall initiation, according to Fierce Pharma.
The FDA's Class II classification is consistent with Amgen's assessment: a low but non-zero risk that is "medically reversible" rather than life-threatening in nature.
The recall covers the following specific products:
5 mg Corlanor (ivabradine) tablets:
- 14-tablet bottles (NDC 55513-800-99)
- 60-tablet bottles (NDC 55513-800-60)
Affected lot numbers and expiration dates (5 mg lots):
- Lot 1138901, Exp. 08/31/2026
- Lot 1149846, Exp. 04/30/2027
- Lots 1138201 and 1138202, Exp. 08/31/2026
- Lot 1138900, Exp. 08/31/2026
- Lot 1141143, Exp. 08/31/2026
- Lots 1140280 and 1140281, Exp. 10/31/2026
- Lots 1142062 and 1142063, Exp. 11/30/2026
- Lots 1142942 and 1142943, Exp. 11/30/2026
- Lots 1144081 and 1144104, Exp. 12/31/2026
- Lots 1146373 and 1146374
7.5 mg Corlanor (ivabradine) tablets:
- An undisclosed quantity of 60-tablet bottles is also included in the recall; patients should check the FDA recall notice for the complete 7.5 mg lot number listing.
This recall does not affect generic ivabradine sold under other brand names or from other manufacturers. It is specific to Amgen's Corlanor brand lots manufactured in Italy during the affected period.
The same recall action also covers Sensipar (cinacalcet hydrochloride) tablets, an Amgen product used to treat hyperparathyroidism in patients with chronic kidney disease. If you take Sensipar, check the FDA recall page for affected Sensipar lots separately.
Where the Affected Medication Was Distributed
According to Amgen and FDA records, the recalled tablets were distributed by Amgen across the United States between October 28, 2021, and December 30, 2025, according to Fox Business reporting. The wide distribution window and the volume of 934,577+ bottles mean affected lots may be in patients' homes in all 50 states.
What Doctors and Experts Say
Corlanor (ivabradine) is approved by the FDA to reduce the risk of hospitalization for worsening heart failure in adults with stable, symptomatic chronic heart failure. It works by selectively reducing the heart rate in patients with elevated resting heart rates. It is also prescribed off-label by some cardiologists for postural orthostatic tachycardia syndrome (POTS), a condition involving abnormal heart rate increases when moving from a lying to standing position, though this is not an FDA-approved indication for the drug.
The Mayo Clinic describes ivabradine as working by "slowing the electrical impulses in the heart." Abruptly stopping the medication can cause heart rate to rebound above pre-treatment levels, a phenomenon that can worsen heart failure symptoms or trigger a rapid heart rate episode in susceptible patients.
Cardiologists contacted by multiple outlets have uniformly advised the same response: check your lot number, contact your prescribing cardiologist or pharmacist, and do not stop or modify the medication without medical guidance.
What the Evidence Shows and What It Does Not
The foreign matter in the recall is described as a surface coating contaminant, not a chemical contamination of the active drug itself. The specific nature of the foreign substance has not been publicly identified by Amgen. The FDA's Class II classification means the agency has determined the substance poses a low probability of causing serious adverse health consequences but that temporary or reversible effects are possible.
No clinical evidence of patient harm from the affected lots has been published or reported as of this writing.
MedicalDaily Evidence Check
- Source: FDA recall classification June 23, 2026; Amgen voluntary recall initiated June 4, 2026; Fierce Pharma; The Hill; Cardiovascular Business; PIX11 / The Healthy (lot numbers)
- What it shows: 934,577+ bottles of 5 mg Corlanor recalled; undisclosed quantity of 7.5 mg Corlanor recalled; FDA Class II classification; foreign matter on exterior tablet coating; no patient complaints or adverse events reported at recall initiation
- What it does not prove: That any patient was harmed; the specific composition of the foreign substance
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What readers should know: Check your lot number; contact your pharmacist or cardiologist; do not stop the medication without medical guidance
Who Is Affected?
Adults with chronic heart failure who were prescribed Corlanor (ivabradine 5 mg or 7.5 mg) and received their medication from any U.S. pharmacy between late October 2021 and December 2025 may have affected lots. The broad distribution window means patients who filled their prescription months ago may still have affected tablets at home.
Corlanor is also approved for children aged 6 months and older with stable, symptomatic heart failure caused by dilated cardiomyopathy. Parents of children taking Corlanor should check lot numbers equally carefully.
Symptoms and Warning Signs to Watch For
The foreign matter in the recall is described as a surface coating issue with low health risk potential. Patients who have taken affected lots and experience any of the following should contact their healthcare provider:
- Unusual taste, smell, or visual appearance of tablets not previously noticed
- Any new unexplained symptoms that arose after taking medication from the potentially affected lot
Separately, patients who miss doses or run low on medication while awaiting a replacement should watch for worsening heart failure symptoms:
- Increased shortness of breath, particularly when lying flat
- Swelling in the ankles, feet, or legs
- Unusual fatigue or weakness
- Rapid or irregular heartbeat
These symptoms require prompt medical evaluation and should prompt immediate contact with a cardiologist.
What You Can Do Now
- Find your Corlanor bottle and locate the lot number, printed on the label or side panel of the bottle.
- Compare your lot number against the list above or against the complete FDA recall notice at FDA.gov recalls .
- If your lot number is included in the recall, contact your pharmacist. Many pharmacies can facilitate an exchange for non-recalled product or arrange a bridge prescription while the situation is resolved.
- Contact your cardiologist to discuss the situation and confirm the appropriate plan. Do not stop or skip doses of Corlanor without medical guidance; missing doses of a heart failure medication can worsen your condition.
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Patients can also contact Amgen Medical Information directly at 1-800-772-6436 (800-77-AMGEN) for specific questions about the recall.
Cost and Access: What Patients Should Know
Recalled medication should be exchanged at no additional cost through your pharmacy. If you have difficulty accessing a replacement, contact your cardiologist's office for an emergency prescription or alternative supply guidance. If you are uninsured or underinsured, federally qualified health centers and hospital outpatient cardiology programs may be able to provide a bridge supply.
Corlanor is currently available only as a brand-name product; there is no FDA-approved generic ivabradine from alternative manufacturers available in the United States as of this writing. This limits the immediate substitution options to obtaining non-recalled lots of the same product.
What Happens Next
Amgen is working with pharmacies, hospitals, and distributors to facilitate the return and replacement of recalled lots. The FDA's complete lot-number listing is maintained on the FDA enforcement reports page and will be updated as additional information becomes available.
MedicalDaily will report if additional lots are added to the recall or if new information about the foreign substance is released.
The Bottom Line
Nearly one million bottles of Corlanor (ivabradine), a heart failure medication manufactured in Italy by Amgen, were recalled beginning June 4, 2026, after foreign matter was found on the exterior coating of some tablets. The FDA classified this as Class II, meaning the risk is real but low and reversible. Patients who take Corlanor should check their lot numbers against the FDA recall list, contact their pharmacist for an exchange, and speak with their cardiologist before making any changes to how they take the medication. Do not stop Corlanor abruptly — heart failure medications require medical supervision to adjust safely.
