Consumer Alerts Tracker
openFDA Drug

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

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

Official details

Category
Drug recall
Status
Ongoing
Classification
Class II
Company or vendor
The Harvard Drug Group LLC
Affected product
Nationwide in the USA
Risk or reason
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Remedy or action
Lot#: Lot N02406, Exp 10/31/2026; Lot N02845, Exp 12/31/2026
Official ID
D-0493-2026