Why it was recalled
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: S2520249, S2520250, S2520267, Exp. Date 2027/Jan; S2520303, S2520305, S2520332, Exp. Date 2027/Feb; S2540208, S2540209, Exp. Date 2027/Apr
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0400-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 9, 2026
- FDA report date
- Mar 18, 2026
- Quantity
- 60,541 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
Original FDA data
Every field from FDA enforcement report D-0400-2026, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 98560
- Address
- 73 Route 31 N
- Code information
- Lot #: S2520249, S2520250, S2520267, Exp. Date 2027/Jan; S2520303, S2520305, S2520332, Exp. Date 2027/Feb; S2540208, S2540209, Exp. Date 2027/Apr
- Postal code
- 08534-3601
- Report date
- Mar 18, 2026
- Product type
- Drugs
- Recall number
- D-0400-2026
- Classification
- Class II
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Product quantity
- 60,541 bottles
- Reason for recall
- Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 9, 2026
- Initial firm notification
- Letter
- Center classification date
- Mar 20, 2026