FDAFDA · Food and drugs·Recall number D-0400-2026
Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1592-7
Published March 18, 2026 · Recall initiated: March 9, 2026
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
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ICOSAPENT ETHYL
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Distributor
- Nationwide in the USA
- UPC
- 0370710159276
- Lot
- Lot #: S2520249, S2520250, S2520267, Exp. Date 2027/Jan; S2520303, S2520305, S2520332, Exp. Date 2027/Feb; S2540208, S2540209, Exp. Date 2027/Apr
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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