FDAHealthDecember 30, 2025
Zydus Pharmaceuticals (USA) Inc — Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc.,
⚠️ Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 30, 2025
US Nationwide.
What's affected?
- Product
- 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
- Lot code
- S2520304
Additional details
Lot # S2520304, S2520333, Exp 2/28/2027; S2540186, Exp 4/30/2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 22,896 bottles.
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