FDAFDA · Food and drugs·Recall number D-0295-2026
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
Published January 28, 2026 · Recall initiated: December 30, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Distributor
- US Nationwide.
- Lot
- Lot # S2520304, S2520333, Exp 2/28/2027; S2540186, Exp 4/30/2027
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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