Omega-3-Acid — Class II drug recall D-0493-2026
Ongoing recall by The Harvard Drug Group LLC, reported 2026-04-29, distributed nationwide. Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss
| Recall number | D-0493-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Harvard Drug Group LLC, Dublin, OH, United States |
| Recall initiated | 2026-04-09 |
| Classified | 2026-04-24 |
| Reported by FDA | 2026-04-29 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 00904-7495, 00904-7495-06 |
| Lot numbers | N02406, N02845 |
| Expiration dates | 2026-10-31, 2026-12-31 |
Product
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
Reason for recall
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0493-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.