Popular Heart Disease Drug Recalled for Leakage That Could Reduce Effectiveness and Cause Stomach Upset
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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.
Heart Disease Drug Recalled Nationwide for Leaking That Could Reduce Potency
Everyday Health
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Published on February 5, 2026
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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
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Resources
  1. Enforcement Report Event ID: 98227. U.S. Food and Drug Administration. January 22, 2026.
  2. Icosapent Ethyl (Oral Route). Mayo Clinic.
  3. Recalls Background and Definitions. U.S. Food and Drug Administration. July 31, 2014.
  4. Drug Recall Information for Consumers, Health Care Professionals and Industry. U.S. Food and Drug Administration. October 30, 2025.
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