FDA Recalls Over 940,000 Bottles of Heart and Kidney Medications Nationwide
The U.S. Food and Drug Administration (FDA) has announced a Class II nationwide recall affecting more than 944,000 bottles of essential heart failure and kidney disease medications. Distributed by Amgen, Inc., the affected batches are being pulled due to manufacturing compliance issues and the presence of foreign substances in select bottles.
If you or a loved one take prescription heart or kidney treatments, here is what you need to know about the affected medications, lot numbers, and safety steps.
Which Medications Are Included in the Recall?
The recall specifically targets select lots of Corlanor (ivabradine) and Sensipar (cinacalcet). Both medications are widely prescribed to manage chronic cardiovascular and metabolic health conditions:
- Corlanor (ivabradine) 5 mg and 7.5 mg Tablets Corlanor is routinely prescribed to manage chronic heart failure and lower elevated heart rates. The recall includes both 14-count and 60-count bottles across multiple lot numbers with expiration dates extending through 2028.
- Sensipar (cinacalcet) 30 mg, 60 mg, and 90 mg Tablets Sensipar is used to lower secondary hyperparathyroidism in adults with chronic kidney disease on dialysis, as well as managing high calcium levels in patients with parathyroid carcinoma.
The FDA classified this action as a Class II recall. A Class II classification means that exposure to the affected product may cause temporary or medically reversible adverse health consequences, though the probability of serious harm is considered remote.
Why Was the Recall Issued?
According to official FDA enforcement reports, the recall was initiated following two main concerns:
Current Good Manufacturing Practice (CGMP) Deviations: Inspections identified manufacturing procedural departures at distribution facilities.
Foreign Substance Contamination: Select bottles were found to contain foreign particulate matter, prompting Amgen to initiate a voluntary nationwide withdrawal.
While no acute illnesses or injuries have been officially reported to date, health authorities emphasize that patients should never swallow pills from a compromised or contaminated bottle.
Action Steps for Patients and Caregivers
If you currently take Corlanor or Sensipar, follow these recommended guidelines immediately:
Inspect Your Bottle: Check your prescription container for the National Drug Code (NDC) and lot numbers listed on official FDA enforcement bulletins.
Contact Your Pharmacy: If your bottle matches one of the recalled lots, contact your pharmacy or healthcare provider immediately to secure a safe replacement supply.
Do Not Stop Treatment Abruptly: Patients taking heart failure or kidney medications should never discontinue prescription therapy without consulting their doctor, as sudden cessation can trigger blood pressure spikes or cardiac complications. Ask your pharmacist for an unaffected replacement batch right away.
Report Adverse Reactions: If you experience unexpected symptoms or notice foreign material in your medication, notify your physician and file a report through the FDA MedWatch online portal.