Drug FDA Class II Ongoing Failed specifications

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

The Harvard Drug Group LLC Published Apr 29, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact The Harvard Drug Group LLC or your place of purchase with questions, and see the source record below for full details.

Reason for recall

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

Hazards

Failed Loss on Drying Specification for Capsule Shells · primary

Affected products (1)

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

OMEGA-3-ACID ETHYL ESTERS · 2,238 5 x 10 unit dose cartons

NDC: 0904-7495, 0904-7495-06

Lot codes: N02406, N02845

Code info: Lot#: Lot N02406, Exp 10/31/2026; Lot N02845, Exp 12/31/2026

Affected areas

Nationwide

Timeline

Initiated

Apr 9, 2026
Published

Apr 29, 2026

Recall number: D-0493-2026
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.