Recalls / Class II
Class IID-0400-2026
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 name
- Icosapent Ethyl
- Generic name
- Icosapent Ethyl
- Active ingredient
- Icosapent Ethyl
- Route
- Oral
- NDCs
- 70710-1592, 70710-1738
- FDA application
- ANDA217656
- Affected lot / code info
- Lot #: S2520249, S2520250, S2520267, Exp. Date 2027/Jan; S2520303, S2520305, S2520332, Exp. Date 2027/Feb; S2540208, S2540209, Exp. Date 2027/Apr
Why it was recalled
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Recalling firm
- Firm
- Zydus Pharmaceuticals (USA) Inc
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, N/A, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- 60,541 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2026-03-09
- FDA classified
- 2026-03-20
- Posted by FDA
- 2026-03-18
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0400-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.