FDA drug recalls · openFDA
Is OMEGA-3-ACID ETHYL ESTERS recalled?
The FDA has recorded 1 recall of OMEGA-3-ACID ETHYL ESTERS (2026) , recalled under brand like OMEGA-3-ACID ETHYL ESTERS. 1 still ongoing.
A recall doesn't mean your pills are affected
Drug recalls are issued by lot (specific batches, identified by lot numbers / NDC) — not for every bottle of OMEGA-3-ACID ETHYL ESTERS ever made. To know if yours is involved, match the lot codes on the recall below against your bottle, or ask your pharmacist. Do not stop a prescribed medication because of a recall without talking to your pharmacist or prescriber — stopping can be more dangerous than the recall. The Class is the FDA's risk judgment (Class I = reasonable probability of serious harm or death), not a measurement that harm occurred; most recalls are voluntary and Class II/III.
Why it was recalled
The recalls
Class I and ongoing recalls first. Tap a recall for its full record and lot detail.
RECORDED — these are the FDA's published recall enforcement records (openFDA), grouped by the generic drug name. Scope: drug recalls the FDA recorded with a generic name; device recalls and recalls without a generic name are in the full recall browse. "Ongoing" reflects openFDA's last-published status — confirm current status and your lot at the FDA recall database. This page informs and routes; it is not medical advice.