Amgen has recalled nearly one million bottles of Corlanor and Sensipar tablets nationwide after unexpected foreign matter was found on the surface of some tablets during product sampling.
The voluntary recall involves heart and kidney-related medications distributed in the United States between October 28, 2021, and December 30, 2025. The affected products include Corlanor (ivabradine) and Sensipar (cinacalcet hydrochloride).
Recall Covers Corlanor and Sensipar
The recall affects at least 944,142 bottles of prescription medication. Amgen, based in Thousand Oaks, California, initiated the action after foreign matter was detected in a reserve sample from one identified lot.
The products were processed in the same packaging area where the issue occurred. Amgen expanded the recall to all in-date lots from that area as a precaution.
The June 5 recall alert listed 63 lots of U.S. Corlanor and three lots of U.S. Sensipar. The affected Corlanor tablets include 5 mg and 7.5 mg presentations. Sensipar products covered by the recall include 30 mg, 60 mg, and 90 mg tablets. Each recalled Sensipar product was packaged in 30-count bottles.
Foreign Matter Was Found on Tablet Surfaces
The foreign matter was found on the exterior tablet surface, over the coating. Public recall details did not identify the substance. The recall notice said the issue was found during reserve sample review. Reserve samples are retained by drugmakers for quality checks after production and distribution.
The notice described the event as low frequency. It also said no product complaints linked to the issue had been reported at the time of the recall.
Amgen’s hazard assessment found that the foreign material did not pose a clinical risk to patients. The company also described the overall patient safety risk as low.
FDA Classification Signals Limited Risk
The recall has been listed as a Class II recall category, which applies when a product may cause temporary or medically reversible adverse health consequences. It also applies when the chance of serious harm is remote. Class II recalls are not the FDA’s highest risk category. Class I recalls are used when a product may cause serious injury or death.
The classification still requires attention from pharmacies, patients, and prescribers. The affected drugs are used by patients with chronic medical conditions.
Patients should not stop taking prescribed medication without professional guidance. A sudden interruption may create separate health risks, especially for people being treated for heart failure or kidney disease.
Corlanor Is Used in Heart Failure Care
Corlanor is a prescription medicine used for certain patients with chronic heart failure. It helps reduce the risk of hospitalization for worsening heart failure in patients who meet specific treatment criteria.
The Corlanor heart failure indication covers selected adults with stable, symptomatic chronic heart failure and an elevated resting heart rate. The drug is also approved for certain pediatric patients with stable symptomatic heart failure due to dilated cardiomyopathy. The recalled Corlanor products include 5 mg tablets in 60-count bottles with NDC 55513-800-60. They also include 5 mg tablets in 14-count bottles under the NDC 55513-800-99.
The recall also covers 7.5 mg Corlanor tablets in 60-count bottles under NDC 55513 810 60. Expiration dates for affected Corlanor lots extend from 2026 through 2028.
Patients taking Corlanor should compare the label on their bottle with the recalled drug name, strength, NDC, and lot information. If the lot number is not visible, the dispensing pharmacy can help verify whether the medication is included.
Sensipar Is Used in kidney-related conditions.
Sensipar is used to treat conditions involving parathyroid hormone and calcium levels. It is commonly prescribed for adult patients with chronic kidney disease who are on dialysis.
The Sensipar kidney disease use includes secondary hyperparathyroidism in adult patients with chronic kidney disease on dialysis. It is also used for certain patients with parathyroid carcinoma or primary hyperparathyroidism when clinically appropriate. The recalled 30 mg Sensipar product has NDC 55513-073-30. The affected lot is 1156858, with an expiration date of December 31, 2027.
The recalled 60 mg Sensipar product has NDC 55513-074-30. The affected lot is 1157055, with an expiration date of January 31, 2028.
The recalled 90 mg Sensipar product has NDC 55513-075-30. The affected lot is 1157056, with an expiration date of February 29, 2028.
Patients Should Check Bottles Before Acting
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Patients should check the medication name, strength, NDC, lot number, and expiration date on their prescription bottle. Those details are needed to confirm whether a specific bottle is affected.
Some patients may not see the original manufacturer lot number if the medicine was placed into a pharmacy bottle. In that case, the pharmacy may be able to trace the product through dispensing records.
Patients with a matching bottle should contact their pharmacy for instructions on replacement or return. They should also contact their prescriber before stopping, skipping, or changing any dose. People who experience symptoms or have concerns after taking the medication should seek medical advice. Adverse events or quality problems may also be reported through federal drug safety reporting channels.
Pharmacies Review Affected Inventory
Pharmacies are expected to review their inventory and recall procedures for the affected Amgen products. That review may include shelf stock, returned stock, and records of previously dispensed medication.
The recall can also affect hospitals, clinics, and long-term care pharmacies that stocked or dispensed the products during the distribution window. Facilities may need to identify affected lots and remove them from use.
The latest public status shows the recall remains active for the listed Corlanor and Sensipar lots. Patients with affected medication should contact a pharmacist or prescriber for the safest next step.
Roselydah Eunice is a writer and sports professional. Since 2016, she has specialized in creating engaging social media content, authentic journal-style reflections, and persuasive commentary designed to spark meaningful discussions. A former professional player in the FKF Women's Premier League and a certified football coach, Roselydah uniquely blends her passion for sports leadership with a gift for clear storytelling. Her goal is always to build authentic connections and write content that resonates deeply with her readers.
