FDA recall D-0493-2026

The Harvard Drug Group LLC · Class II · drug

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 for recall

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

Distribution

Nationwide in the USA

Key facts

Status: Ongoing
Initiation date: 2026-04-09
Report date: 2026-04-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Dublin, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0493-2026