Amgen, Inc. has initiated a voluntary recall of nearly one million bottles of Corlanor and Sensipar tablets after discovering foreign matter in a reserve sample, according to the California State Board of Pharmacy. The U.S. Food and Drug Administration (FDA) has classified the move as a Class II recall, indicating the affected medication may cause temporary or reversible adverse health consequences.
Why were these heart and kidney medications recalled?
The recall stems from the discovery of “unexpected foreign matter” located on the exterior coating of tablets, according to the California State Board of Pharmacy. Amgen, the California-based manufacturer, identified the issue in a reserve sample from a specific packaging area, identified as AML Building 23. While the company has not received reports of patient complaints, it is recalling all lots within their expiry dates that were processed in that facility as a precautionary measure. The Board of Pharmacy states that current hazard assessments suggest the clinical risk to patients remains low.
The FDA classifies recalls into three levels. A Class II recall—the category assigned to this Amgen event—is reserved for products that might cause temporary, medically reversible health problems, rather than the more severe “Class I” designation, which involves situations where there is a reasonable probability that the use of the product will cause serious adverse health consequences or death.
Which specific products are affected by the recall?
The recall impacts a significant volume of medication distributed between October 28, 2021, and December 30, 2025. According to the California State Board of Pharmacy, the recall includes the following presentations:
- Corlanor (ivabradine): 5 mg, 60-count and 14-count bottles (NDC 55513-800-60, 55513-800-99, 55513-810-60).
- Sensipar (cinacalcet hydrochloride): 30 mg, 60 mg, and 90 mg in 30-count bottles (NDC 55513-073-30, 55513-074-30, 55513-075-30).
Corlanor is primarily prescribed to treat chronic heart failure, while Sensipar is used to manage overactive parathyroidism in patients with chronic kidney disease.
What should patients do if they have these medications?
Patients currently taking Corlanor or Sensipar should not immediately stop their treatment, as doing so could pose health risks. Experts advise consulting with a healthcare provider or pharmacist to verify if a specific prescription bottle is part of the affected lot numbers. Pharmacies are typically equipped to check NDC codes against the FDA database to confirm if a return or exchange is necessary.
Always keep your medication in its original packaging. The National Drug Code (NDC) printed on the bottle is the most reliable way to identify if your specific supply is subject to a manufacturer or FDA recall.
How does this recall compare to other recent pharmaceutical alerts?
This recall follows a broader trend of supply chain scrutiny within the pharmaceutical industry. While the Amgen recall involves a localized foreign matter issue, other recent actions—such as the FDA’s recall of certain Costco-brand cold and flu medications due to efficacy concerns—highlight the varying reasons for market removals. Unlike the Costco recall, which focused on the effectiveness of the drug, the Amgen recall is strictly related to physical contamination during the packaging process.
Frequently Asked Questions
Is the medication safe to take if I already started the bottle?
The California State Board of Pharmacy indicates that the overall patient safety risk is low, but you should verify your bottle’s lot number against the official list provided by your pharmacy or the FDA.
Are there any known injuries related to this recall?
No. According to reports from the California State Board of Pharmacy, there have been no complaints or reports of adverse events linked to these specific medication lots.
What is the difference between Corlanor and Sensipar?
Corlanor (ivabradine) is used for chronic heart failure, whereas Sensipar (cinacalcet hydrochloride) is used for kidney disease patients with overactive parathyroidism.
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