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Omega-3-Acid Ethyl Esters Capsules Recall

Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distribute

Updated April 9, 2026

The Harvard Drug Group is recalling Omega-3-Acid Ethyl Esters capsules because the capsule shells failed stability testing and do not meet specifications for moisture content. This could affect the capsule's ability to protect and release the medication properly.

Is the The Harvard Drug Group LLC recalled? Yes. This product was recalled by FDA on April 9, 2026. Details below.

What is recalled

Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton. NDC: 0904-7495-06. Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN 46288. Prescription only.

Am I affected

You are affected if you have a prescription for Omega-3-Acid Ethyl Esters capsules (1 gram) with NDC number 0904-7495-06 packaged in blister card cartons by Major Pharmaceuticals.

What to do right now

Contact your pharmacy or prescriber to return this medication. Do not take remaining capsules without speaking to your doctor or pharmacist about whether to stop or switch to an alternative.

The hazard

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

Brands affected

The Harvard Drug Group LLC
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0493-2026
Classification
Class II
Recalled
April 9, 2026
Read the official notice

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