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Omega-3-Acid Ethyl Esters Capsules
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DRUG RECALLMODERATE

Omega-3-Acid Ethyl Esters Capsules

Major Pharmaceuticals is recalling Omega-3-Acid Ethyl Esters Capsules due to failed stability testing for capsule shell loss on drying.

What to do

Contact your healthcare provider or pharmacist if you have concerns about your medication. Do not stop taking your medication without consulting a medical professional.

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

Why it was recalled

Major Pharmaceuticals is recalling Omega-3-Acid Ethyl Esters Capsules due to failed capsule specifications. Routine stability testing indicated that the capsule shells did not meet requirements for loss on drying. This product was distributed nationwide.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

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

Recall #
D-0493-2026

Where it was sold

Distributed nationwide.

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Editorial summary by Recall Canary · last updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification