FDA Drug recall D-1074-2018
Omega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle Rx Only
- FDA Drug
- Class II
- terminated
- Published 2018-08-15
On 2018-08-15 the FDA classified a Class II recall of Omega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle Rx Only by Teva Pharmaceuticals Usa, citing API material used in the manufacturing of the product did not receive regulatory approval prior to release.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1074-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-16 |
| Published | 2018-08-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
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
API material used in the manufacturing of the product did not receive regulatory approval prior to release.
Identifiers
| code_info | Lot # 150001420A, EXP 2/2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1074-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.