Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Icosapent Ethyl Capsules 1 gram Recalled by Zydus Pharmaceuticals (USA) Inc Due to Failed Tablet/Capsule specifications; a product complaint was reported...
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 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza, Italy, Distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-7.
Quantity: 11,616 bottles
Why Was This Recalled?
Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.
Where Was This Sold?
This product was distributed to 3 states: IL, MS, PA
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