United StatesOmega-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, NDC 0904-7495-06, lots N02406 (exp 10/31/2026) and N02845 (exp 12/31/2026) are affected. The Harvard Drug Group LLC is recalling these cartons because routine stability testing found out-of-specification results for loss on drying of the capsule shells.
What's being recalled
Omega-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 firm: The Harvard Drug Group LLC, Dublin, OH, United States.
How to identify it
Lot#: Lot N02406, Exp 10/31/2026; Lot N02845, Exp 12/31/2026
The hazard
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide in the USA
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)