Nearly 1 Million Bottles of Heart and Kidney Medications Recalled Nationwide

Nearly one million bottles of two commonly prescribed medications used to treat chronic heart failure and complications related to chronic kidney disease have been voluntarily recalled after an unexpected foreign substance was discovered on some tablets.

The recall was initiated by Amgen and affects approximately 944,000 bottles of the medications after foreign material was identified on the outer coating of tablets during routine quality testing. The contamination appears to have been isolated to a packaging area within one manufacturing facility, and officials say the overall risk to patients remains low. No injuries or adverse events related to the issue have been reported.

Which Medications Have Been Recalled?

The recall includes the following prescription medications:

• Corlanor (ivabradine) — a medication used to help reduce hospitalizations in adults living with certain forms of chronic heart failure.
• Sensipar (cinacalcet hydrochloride) — a medication commonly prescribed to patients with chronic kidney disease who develop secondary hyperparathyroidism, also known as overactive parathyroid glands.

Several dosage strengths and lot numbers of both medications are included in the recall (listed below), with products distributed throughout the United States between October 2021 and December 2025. The FDA has classified the action as a Class II recall, meaning exposure to the affected medications could potentially cause temporary or medically reversible health problems, although the chance of serious injury is considered low.

The recall includes the following presentations, according to the board:

• Corlanor® (ivabradine) 5 mg, 60 tablets in 1 bottle; NDC 55513-800-60

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• Corlanor® (ivabradine) 5 mg, 14 tablets in 1 bottle; NDC 55513-800-99

• Corlanor® (ivabradine) 5 mg, 60 tablets in 1 bottle; NDC 55513-810-60

• Sensipar® (cinacalcet hydrochloride) 30 mg, 30 tablets in 1 bottle; NDC 55513-073- 30

• Sensipar® (cinacalcet hydrochloride) 60 mg, 30 tablets in 1 bottle; NDC 55513-074- 30

What Should You Do If You Have One of the Recalled Bottles?

If you currently take Corlanor or Sensipar:

1. Check the lot number and expiration date on your prescription bottle against the FDA recall list.
2. Do not stop taking your medication abruptly unless instructed by your physician. Suddenly stopping heart failure or kidney medications can lead to worsening symptoms or hospitalization.
3. Contact your pharmacist or prescribing healthcare provider to determine whether your bottle is affected and to arrange for a replacement medication if necessary.
4. Follow your pharmacy’s instructions regarding returns or disposal. Many pharmacies can exchange recalled medications or direct patients to approved medication take-back programs.

Symptoms of Heart Failure to Watch For

Corlanor is prescribed to patients with chronic heart failure, a condition in which the heart cannot pump blood efficiently enough to meet the body’s needs.

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Common symptoms include:

• Shortness of breath during activity or while lying down
• Persistent fatigue or weakness
• Swelling in the feet, ankles, legs, or abdomen
• Rapid or irregular heartbeat
• Persistent coughing or wheezing
• Sudden weight gain from fluid retention
• Difficulty exercising or performing daily activities
• Reduced appetite or nausea
• Difficulty concentrating or confusion in older adults

Seek immediate medical attention if you experience severe shortness of breath, chest pain, fainting, or sudden swelling that worsens quickly.

Symptoms of Overactive Parathyroidism in Chronic Kidney Disease Patients

Sensipar is frequently prescribed to treat secondary hyperparathyroidism, a condition that develops when damaged kidneys are unable to properly regulate calcium, phosphorus, and vitamin D levels. In response, the parathyroid glands produce excessive amounts of parathyroid hormone (PTH).

Symptoms can include:

• Bone pain or frequent fractures
• Muscle weakness
• Joint pain
• Itching skin
• Fatigue and low energy
• Loss of appetite
• Nausea or vomiting
• Difficulty concentrating or memory problems
• Depression or mood changes
• Muscle cramps
• Elevated calcium or phosphorus levels on blood tests

If left untreated, secondary hyperparathyroidism can contribute to cardiovascular disease, calcification of blood vessels, and severe bone disease in patients with chronic kidney disease. Early treatment and regular monitoring of calcium, phosphorus, and PTH levels are important for preventing complications.

What To Do If You Have the Recalled Bottles

Patients who believe they may have an affected medication should contact their pharmacist, nephrologist, cardiologist, or primary care provider for guidance rather than discontinuing treatment on their own.