Omega-3-acid Ethyl Esters recalls
The FDA has published 3 recalls involving Omega-3-acid Ethyl Esters since 2014. The latest was reported on 29 Apr 2026. Most were for labeling errors. The Harvard Drug Group has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls3since 2014
Last 12 months1reported
Class I00% of total
Ongoing1latest 29 Apr 2026
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 3 100%Class III 0 0%
Why omega-3-acid ethyl esters is recalled
Companies
By year
Ongoing omega-3-acid ethyl esters recalls
1 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Omega-3-Acid, Ethyl Esters, Capsules recalled by The Harvard Drug GroupOmega-3-acid Ethyl Esters | The Harvard Drug Group | Potency & Assay | Nationwide |
All omega-3-acid ethyl esters recalls, newest first
3 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Omega-3-Acid, Ethyl Esters, Capsules recalled by The Harvard Drug GroupOmega-3-acid Ethyl Esters | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Omega-3-Acid Ethyl Esters Capsules USP* recalled | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Omega-3-Acid Ethyl Esters, Capsule, 1000 mg, Over The Counter recalled | Aidapak Services | Labeling Errors | 4 states |
Should you stop taking Omega-3-acid Ethyl Esters?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.