Drug Recall: 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, N
Zydus Pharmaceuticals (USA) Inc · May 30, 2025
Reason for Recall
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.
Product Description
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.
Distribution
IL, PA, & MS
States Affected
IL, MS, PA
Quantity Affected
11,616 bottles
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0497-2025
Status: ongoing
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