Why it was recalled
Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.
Product description
Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza, Italy, Distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-7.
Lot numbers, UPCs & expiration codes
Lot #s: B237040, B237041, Exp 10/31/2025
Where it was sold
IL, PA, & MS
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-0497-2025
- Classification
- Class II
- Status
- Completed
- Recall initiated
- May 30, 2025
- FDA report date
- Jun 18, 2025
- Quantity
- 11,616 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
Original FDA data
Every field from FDA enforcement report D-0497-2025, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Completed
- Country
- United States
- Event ID
- 96964
- Address
- 73 Route 31 N
- Code information
- Lot #s: B237040, B237041, Exp 10/31/2025
- Postal code
- 08534-3601
- Report date
- Jun 18, 2025
- Product type
- Drugs
- Recall number
- D-0497-2025
- Classification
- Class II
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Product quantity
- 11,616 bottles
- Reason for recall
- Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza, Italy, Distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-7.
- Distribution pattern
- IL, PA, & MS
- Recall initiation date
- May 30, 2025
- Initial firm notification
- Letter
- Center classification date
- Jun 30, 2025