Omega-3-Acid Ethyl Esters Capsules USP — Class II drug recall D-1074-2018
Terminated recall by Teva Pharmaceuticals USA, reported 2018-08-15, distributed nationwide. API material used in the manufacturing of the product did not receive regulatory approval prior to release.
| Recall number | D-1074-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, North Wales, PA, United States |
| Recall initiated | 2018-07-16 |
| Classified | 2018-08-08 |
| Reported by FDA | 2018-08-15 |
| Terminated | 2019-03-28 |
| Distributed | Nationwide (US) |
| NDC | 00093-5401-89 |
| Lot numbers | 150001420A |
| Expiration dates | 2019-02 |
Product
Omega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle Rx Only. Manufactured by: Banner Pharmacaps, Inc. High Point, NC 27265. Manufactured for: Teva Pharmaceuticals USA Inc. North Wales, PA 19454 NDC 0093-5401-89
Reason for recall
API material used in the manufacturing of the product did not receive regulatory approval prior to release.
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-1074-2018. 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.