Zydus Pharmaceuticals recalled 22,896 bottles of Icosapent Ethyl capsules on December 30, 2025. The recall stems from leakage and oxidation that may reduce the drug's effectiveness. Consumers should stop using the product immediately and seek guidance from healthcare providers.
Subpotent Drug: Due oxidation caused by leakage of the contents of the Icosapent Ethyl 1g capsules. Use of the affected product may lead to inconsistent therapeutic effects and an increase in potential gastrointestinal side effects in some patients.
Consumers and healthcare providers should stop using this product immediately. Contact Zydus Pharmaceuticals (USA) Inc or your healthcare provider for guidance. Notification method: Letter
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Icosapent Ethyl capsules are a prescription medication used to lower triglyceride levels in patients at risk for cardiovascular disease. These capsules are typically prescribed to improve overall heart health and are taken as directed by healthcare providers.
The capsules may lose potency due to leakage, leading to inconsistent therapeutic effects. Patients may not receive the intended benefits, and some may experience increased gastrointestinal side effects due to the degradation of the drug.
This recall is not part of a broader industry pattern.
Consumers may face health risks due to the potential ineffectiveness of the medication. This could lead to increased triglyceride levels and related health issues, making prompt action necessary.
The lot number and expiration date can typically be found on the label of the bottle or packaging.
Expect a refund or resolution within 4-6 weeks after contacting Zydus Pharmaceuticals.
Keep a record of any communications you have regarding the recall, including emails, letters, and phone call notes.
The recall involves Icosapent Ethyl capsules, 1 gram, in 120-count bottles. The affected lot numbers include S2520304, S2520333, and S2540186, with expiration dates of February 28, 2027, and April 30, 2027. These products were manufactured by Softgel Healthcare Pvt. Ltd. in India.
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