Class II
Ongoing
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
- Company
- Zydus Pharmaceuticals (Usa) Inc
- Recall Initiated
- December 30, 2025
- Posted
- January 28, 2026
- Recall Number
- D-0295-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 22,896 bottles
- Firm Location
- Pennington, NJ, United States
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
US Nationwide.
Lot / Code Info
Lot # S2520304, S2520333, Exp 2/28/2027; S2540186, Exp 4/30/2027
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