D-0295-2026 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- January 28, 2026
- Initiation Date
- December 30, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22,896 bottles
Product Description
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
Reason for Recall
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.
Distribution Pattern
US Nationwide.
Code Information
Lot # S2520304, S2520333, Exp 2/28/2027; S2540186, Exp 4/30/2027