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Omega-3-Acid Ethyl Esters Capsules 1 gram
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DRUG RECALLMODERATE

Omega-3-Acid Ethyl Esters Capsules 1 gram

Major Pharmaceuticals is recalling Omega-3-Acid Ethyl Esters Capsules 1 gram (NDC 0904-7495-06) due to failed capsule shell specifications.

What to do

Do not use this medication. Return the product to your pharmacy or contact Major Pharmaceuticals for instructions on proper disposal and replacement.

Posted
Updated
Recall No.
D-0493-2026
Agency
Firm
The Harvard Drug Group LLC
Recall ID
98763
Status
ONGOING

Why it was recalled

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

How to identify it

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

Where it was sold

Distributed in US.

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Editorial summary by Recall Canary · last updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification