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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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.
The capsules may be subpotent due to oxidation caused by leakage. This condition can lead to inconsistent therapeutic effects and increased gastrointestinal side effects.
There are no specific reported injuries or incidents associated with this recall. The potential side effects include gastrointestinal issues, but no serious injuries have been documented.
Consumers should stop using the affected capsules immediately. Contact Zydus Pharmaceuticals at the provided contact information for guidance and potential refunds.
For more details, consumers can visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0295-2026. Reach Zydus Pharmaceuticals at their Pennington, NJ office for direct inquiries.
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