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 to oxidation caused by leakage of the contents of the capsules
Distribution Pattern
US Nationwide.
Code Information
Lot # S2520304, S2520333, Exp 2/28/2027; S2540186, Exp 4/30/2027