Class II Recall

The Harvard Drug Group LLC

Product
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
Reason
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Classification
Class II
Status
Ongoing
Lot
Lot#: Lot N02406, Exp 10/31/2026; Lot N02845, Exp 12/31/2026
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
The Harvard Drug Group LLC — Class II Recall | MedicineWatch US