Drug & medication recalls Moderate risk

The Harvard Drug Group LLC recalls Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Pa…

Recall date
April 9, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0493-2026
FDA classification
Class II
Brand / firm
The Harvard Drug Group LLC
Sold / distributed
Nationwide in the USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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