FDAHealthMarch 9, 2026
Zydus Pharmaceuticals (USA) Inc — Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA)
⚠️ Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 9, 2026
Nationwide in the USA
What's affected?
- Product
- 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
- Brand
- ICOSAPENT ETHYL
- UPC
- 0370710159276
- Lot code
- S2520249
Additional details
Lot #: S2520249, S2520250, S2520267, Exp. Date 2027/Jan; S2520303, S2520305, S2520332, Exp. Date 2027/Feb; S2540208, S2540209, Exp. Date 2027/Apr
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 60,541 bottles.
Get Health recall alerts
Delivered to your inbox. Free. No account required.