Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram
Recalled by The Harvard Drug Group LLC
Class II — moderate
Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
The Harvard Drug Group LLC has recalled Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on April 29, 2026 and was initiated on April 9, 2026. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, with approximately 2,238 5 x 10 unit dose cartons affected. The company behind the recall is The Harvard Drug Group LLC, based in Dublin, OH. The FDA describes the product as: “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”
Why was Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram recalled?
According to the FDA, the stated reason for the recall is: “Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.”
What should you do?
If you think you may have bought Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, compare it against the product description and identifying codes (Lot#: Lot N02406, Exp 10/31/2026; Lot N02845, Exp 12/31/2026) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact The Harvard Drug Group LLC or your local health authority.
About this recall
This recall was distributed in OH. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Full recall details
- Status
- Ongoing
- Date reported
- April 29, 2026
- Recall started
- April 9, 2026
- Distributed in
- OH
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram recalled?+
According to the FDA: Failed Capsule Specifications: Out of specification results obtained during routine stability tes…
How serious is this recall?+
Class II — moderate. Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
What should I do if I have Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0493-2026. Information last synced from the FDA on July 5, 2026.