Why it was recalled
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
Product description
Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-07
Lot numbers, UPCs & expiration codes
Lot # S2520304, S2520333, Exp 2/28/2027; S2540186, Exp 4/30/2027
Where it was sold
US Nationwide.
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-0295-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Dec 30, 2025
- FDA report date
- Jan 28, 2026
- Quantity
- 22,896 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
Original FDA data
Every field from FDA enforcement report D-0295-2026, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 98227
- Address
- 73 Route 31 N
- Code information
- Lot # S2520304, S2520333, Exp 2/28/2027; S2540186, Exp 4/30/2027
- Postal code
- 08534-3601
- Report date
- Jan 28, 2026
- Product type
- Drugs
- Recall number
- D-0295-2026
- Classification
- Class II
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Product quantity
- 22,896 bottles
- Reason for recall
- Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-07
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Dec 30, 2025
- Initial firm notification
- Letter
- Center classification date
- Jan 22, 2026