Zydus Pharmaceuticals (USA) Inc recalls Icosapent Ethyl Capsules
- Recalling company
- Zydus Pharmaceuticals (USA) Inc
- 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
- Reason
- Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Mar 9, 2026
- Reported
- Mar 18, 2026
- Distribution
- Nationwide in the USA
- Status
- Ongoing
- Quantity
- 60,541 bottles
- Lot / codes
- Lot #: S2520249, S2520250, S2520267, Exp. Date 2027/Jan; S2520303, S2520305, S2520332, Exp. Date 2027/Feb; S2540208, S2540209, Exp. Date 2027/Apr
- Company location
- Pennington, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0400-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0400-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.