Recalling firm
Zydus Pharmaceuticals (USA) Inc
Product type
Drug
Status
Ongoing
Report date
2025-06-18
Distribution
IL, PA, & MS
Firm state
NJ
Product quantity
11,616 bottles
Initiated by
Voluntary: Firm initiated
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.
Code / lot info
Lot #s: B237040, B237041, Exp 10/31/2025
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.