D-0497-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- June 18, 2025
- Initiation Date
- May 30, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,616 bottles
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.
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.
Distribution Pattern
IL, PA, & MS
Code Information
Lot #s: B237040, B237041, Exp 10/31/2025