FDA DrugsClass II
Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured...
Published: March 18, 2026Recall ID: D-0400-2026Category: drugsCountry: US
Reason for Recall / Hazard
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Product Description & Identification
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
Affected Products
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
Additional Source Details
| Field | Value |
|---|---|
| City | Pennington |
| State | NJ |
| Openfda › Upc | 0370710159276 |
| Openfda › Unii | 6GC8A4PAYH |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 1304979 |
| Openfda › Rxcui › 2 | 1811180 |
| Openfda › Spl id | b292c3ea-8ce0-471f-8c44-57d1c4df9bf5 |
| Openfda › Brand name | ICOSAPENT ETHYL |
| Openfda › Spl set id | 5910742b-c5e6-4029-9a19-97669e3808bc |
| Openfda › Package ndc › 1 | 70710-1738-4 |
| Openfda › Package ndc › 2 | 70710-1592-7 |
| Openfda › Product ndc › 1 | 70710-1592 |
| Openfda › Product ndc › 2 | 70710-1738 |
| Openfda › Generic name | ICOSAPENT ETHYL |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | ICOSAPENT ETHYL |
| Openfda › Manufacturer name | Zydus Pharmaceuticals USA Inc. |
| Openfda › Application number | ANDA217656 |
| Openfda › Is original packager | true |
| Event id | 98560 |
| Address 1 | 73 Route 31 N |
| Address 2 | N/A |
| Code info | 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 | 20260318 |
| Product type | Drugs |
| 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 |
| Recall initiation date | 20260309 |
| Initial firm notification | Letter |
| Center classification date | 20260320 |
Overview
- Recalling FirmZydus Pharmaceuticals (USA) Inc
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide in the USA