FreshRecalls

⚠ Data freshness notice: the most recent refresh of NHTSA was incomplete, so a very recent recall may be missing. Everything shown is accurate as of the last checked time on this page — for anything time-critical, confirm with the official sources linked below.

FDAClass II · Drug · Recalled April 29, 2026

Omega-3-Acid recall — The Harvard Drug Group LLC

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

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID
D-0493-2026
Brand
The Harvard Drug Group
Classification
Class II
Units affected
2,238 5 x 10 unit dose cartons
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Description

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

Affected products

Companies & origin

Recalling firm location
Dublin, OH, United States
Firm address
7000 Cardinal Pl, N/A, 43017-1091

Identifying details (verbatim from the notice)

Product codes / lots
Lot#: Lot N02406, Exp 10/31/2026; Lot N02845, Exp 12/31/2026
Distribution
Nationwide in the USA
Firm notified the public via
Letter
FDA event ID
98763
Recall initiated
April 9, 2026
FDA classified
April 24, 2026
FDA report date
April 29, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.

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