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FDA · Drugs ·

Omega-3-Acid recall

The Harvard Drug Group LLC recalled Omega-3-Acid on April 29, 2026 because of failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells. It was sold nationwide.

Why it was recalled

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

What's 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

Quantity: 2,238 5 x 10 unit dose cartons

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice