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Class II · ModerateActive recall

Omega-3-Acid Ethyl Esters

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot#: Lot N02406, Exp 10/31/2026; Lot N02845, Exp 12/31/2026
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMajor Pharmaceuticals
Brand nameOMEGA-3-ACID ETHYL ESTERS
Generic nameOMEGA-3-ACID ETHYL ESTERS
Active ingredient(s)OMEGA-3-ACID ETHYL ESTERS
Distributed by / forMajor Pharmaceuticals, Indianapolis, IN 46288
NDC0904-7495-06
Show the full FDA record
Full product labelOmega-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
Recalling firmThe Harvard Drug Group LLC
DistributionNationwide in the USA
Quantity2,238 5 x 10 unit dose cartons
Recall initiated2026-04-09
Report date2026-04-29
Recall completed—
Recall numberD-0493-2026
ClassificationClass II
FDA statusOngoing
Origin on fileDublin OH United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.