Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Icosapent Ethyl capsules Recalled by Zydus Pharmaceuticals (USA) Inc Due to Subpotent Drug: Due oxidation caused by leakage of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Zydus Pharmaceuticals (USA) Inc directly.
Affected Products
Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-07
Quantity: 22,896 bottles
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Zydus Pharmaceuticals (USA) Inc
Zydus Pharmaceuticals (USA) Inc has 51 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report