Drug Recall: Amgen Pulls Nearly 1 Million Bottles of Corlanor and Sensipar Over Foreign Matter Contamination

Amgen, Inc., the maker of two important prescription drugs, has issued a voluntary recall of nearly a million bottles of the products after quality-control inspectors discovered a foreign substance on the surface of some tablet coatings. The drug recall was officially published on the California State Board of Pharmacy and the U.S. Food and Drug Administration (FDA) enforcement reports database.

The recall involves patients in the United States who are depending on these drugs to control more serious chronic diseases such as kidney disease and heart failure. The overall risk to patient safety is estimated to be low, but the extent of the recall, involving nearly a million bottles over 4 years, has attracted much interest.

What Caused the Drug Recall?

The problem was first discovered during “routine” examination of a “reserve sample” taken from one of the manufacturing batches,” said Amgen in a statement announcing the recall. At the company’s AML Building 23 packaging site, investigators discovered foreign material on the tablet’s outer coating, but not inside.

Even though only a few units were found to be contaminated, Amgen decided to consider all lots processed in that specific packaging area and still within their expiration dates as potentially contaminated and recalled. The foreign matter poses a “low potential health risk,” but some of the affected tablets may not meet Amgen’s in-house quality standards for appearance, the company said in a statement.

FDA Class II

This drug recall was rated as Class II, in which “exposure to the affected product is likely to cause temporary or medically reversible adverse health consequences, but the risk of serious health consequences is remote. There are no patient complaints or illnesses reported related to this recall.

Medications Affected by the Recall

The two prescription medicines made by Amgen are for the treatment of different but serious chronic diseases:

Corlanor® (Ivabradine) – Heart Failure Medication

Corlanor (generic name: ivabradine) is a prescription drug to lower the chance of hospitalization in adults with chronic heart failure whose heart rate is too rapid. It acts by modulating heart rate, without impacting blood pressure, via a unique mechanism. It is used to treat patients who don’t get better with other heart failure medications.

Sensipar® (Cinacalcet Hydrochloride) – Kidney Disease Medication

Sensipar, the trade name for cinacalcet hydrochloride, is used mainly to help control secondary hyperparathyroidism in people who have chronic kidney disease and are on dialysis. Lowering parathyroid hormone levels helps control high blood calcium levels, which is a serious problem in dialysis.

Scale and Distribution of the Recall

Patients who have been on these medications for a long time could have received affected bottles at any time between October 28, 2021, and December 30, 2025. The recall includes several different lot numbers, and some of the recalled product could still be in circulation or in patients’ medicine cabinets, with expiration dates ranging from July 2026 through December 2028.

This is one of the largest drug recalls in recent months, in total counting 944,142 bottles, and the need to communicate broadly to patients and have traceability at the pharmacy level.

Risk assessment: what patients need to know?

The California State Board of Pharmacy, which authorized the recall announcement, said it confirmed that Amgen conducted hazard assessments showing no clinical risk to patients from the contamination found. The foreign material was restricted to the tablet surface coating and was not present in the tablet core, where the active pharmaceutical ingredient is located.

Health authorities have said that patients should not discontinue Corlanor or Sensipar without talking to their doctor because sudden withdrawal of a heart failure or kidney failure drug can be hazardous. It is thought that the risk from such patients is higher than the risk from the recalled product.

What should patients do?

• Don’t stop using Corlanor or Sensipar without talking with your doctor or pharmacist.
• Look at the lot number on the bottle of the medicine you are taking and compare it with the complete list of recalled lots on the FDA’s website (accessdata.fda.gov).
• Ask your pharmacist if your medication is from an affected lot and ask for the medication to be replaced if necessary.
• Report any adverse effects or quality concerns to the FDA’s MedWatch program for reporting medication safety information: 1-800-FDA-1088.
• Patients who have concerns about Corlanor call Amgen’s medical information line, and patients with concerns about Sensipar call the medical information line.

Amgen’s Response and Next Steps

Amgen has called the recall a “precautionary measure” based on its “commitment to product quality” and not an effort to address patient harm. This foreign object, which was discovered during internal quality surveillance, is part of a normal procedure to detect problems before they can affect patients on a large scale, the company said. As of the date of the recall, no complaints regarding the contamination have been received from either healthcare practitioners or patients.

Pharmacies and healthcare distributors that have received the impacted product should isolate it and return it via Amgen’s regular product recall logistics system. Healthcare professionals who prescribe these drugs are advised to check the lot numbers and engage in proactive dialogue with their patients.

Understanding FDA Drug Recall Classifications

The FDA’s recall classification system helps consumers and healthcare professionals understand the relative risk level of a given recall. Class I is the most serious, reserved for situations where there is a reasonable probability that using the product will cause serious adverse health consequences or death. Class II, the classification applied to this Amgen recall, covers situations where the product may cause temporary or reversible health effects, with a remote chance of serious consequences. Class III is for products unlikely to cause any adverse health consequences at all.

The Class II classification in this case reflects the FDA’s determination that, although the foreign-matter contamination constitutes a genuine quality violation warranting a drug recall, it does not represent an acute health emergency for patients currently using these medications.

Source 1: Drug Recalls
Source 2: Drug recall: An incubus for pharmaceutical companies and most serious drug recall of history