Heart Disease Drug Recalled Nationwide for Leaking That Could Reduce Potency
More than 20,000 bottles of generic Vascepa — often prescribed with statins to lower heart attack risk — were recalled because oxidation is causing capsules to leak.
A drugmaker has recalled over 20,000 bottles of icosapent ethyl (IPE), a generic version of the triglyceride-lowering medication known by the brand name Vascepa. Oxidation is causing the capsules to leak, which could reduce the drug’s effectiveness and lead to stomach issues, according to an enforcement report from the U.S. Food and Drug Administration (FDA).
Icosapent ethyl is a medication for high triglycerides (fats that circulate in the blood) that contains a highly purified form of omega-3 fatty acids derived from fish oil. Doctors may prescribe icosapent ethyl along with statins to lower the risk of heart attack, stroke, and other cardiovascular complications of heart disease and diabetes.
New Jersey–based Zydus Pharmaceuticals issued a voluntary recall of the following lots of 120-count icosapent ethyl 1-gram capsules:
Lot # S2520304, Exp 2/28/2027
Lot # S2520333, Exp 2/28/2027
Lot # S2540186, Exp 4/30/2027
The enforcement report lists the recall as a Class 2 event, which means use of the recalled product can “cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
There were no specific instructions in the enforcement report about what to do with the recalled icosapent ethyl capsules.
For Class 2 recalls, the FDA says stopping your medicine could be more harmful than continuing to take recalled products.
Contact your pharmacy if you have any concerns or want replacement medication.
EDITORIAL SOURCES
Everyday Health follows strict sourcing guidelines to ensure the accuracy of its content, outlined in our editorial policy. We use only trustworthy sources, including peer-reviewed studies, board-certified medical experts, patients with lived experience, and information from top institutions.
Tom Gavin joined Everyday Health as copy chief in 2022 after a lengthy stint as a freelance copy editor. He has a bachelor's degree in psychology from College of the Holy Cross.
Monroe Hammond joined Everyday Health in 2021 and now runs the news desk as an editor. They received a master’s degree from the Newmark Graduate School of Journalism at CUNY, as we...
