FDA DrugsClass II
Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose...
Published: April 29, 2026Recall ID: D-0493-2026Category: drugsCountry: US
Reason for Recall / Hazard
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Product Description & Identification
Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288. NDC: 0904-7495-06
Affected Products
Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288. NDC: 0904-7495-06
Additional Source Details
| Field | Value |
|---|---|
| City | Dublin |
| State | OH |
| Openfda › Unii | D87YGH4Z0Q |
| Openfda › Route | ORAL |
| Openfda › Rxcui | 577208 |
| Openfda › Spl id | 6e3a56a7-0197-44b8-a345-996d1555a025 |
| Openfda › Brand name | OMEGA-3-ACID ETHYL ESTERS |
| Openfda › Spl set id | e40d55f2-db9f-4a48-8639-9aa7491e4de5 |
| Openfda › Package ndc | 0904-7495-06 |
| Openfda › Product ndc | 0904-7495 |
| Openfda › Generic name | OMEGA-3-ACID ETHYL ESTERS |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | OMEGA-3-ACID ETHYL ESTERS |
| Openfda › Manufacturer name | Major Pharmaceuticals |
| Openfda › Application number | ANDA215458 |
| Openfda › Original packager product ndc | 70756-423 |
| Event id | 98763 |
| Address 1 | 7000 Cardinal Pl |
| Address 2 | N/A |
| Code info | Lot#: Lot N02406, Exp 10/31/2026; Lot N02845, Exp 12/31/2026 |
| Postal code | 43017-1091 |
| Report date | 20260429 |
| Product type | Drugs |
| Product quantity | 2,238 5 x 10 unit dose cartons |
| Reason for recall | Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260409 |
| Initial firm notification | Letter |
| Center classification date | 20260424 |
Overview
- Recalling FirmThe Harvard Drug Group LLC
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide in the USA