Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50… was recalled on April 9, 2026 in cooperation with the U.S. Food and Drug Administration because failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells..
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
Lot#: Lot N02406, Exp 10/31/2026; Lot N02845, Exp 12/31/2026
Units affected: 2,238 5 x 10 unit dose cartons
Where it was sold: Nationwide in the USA
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: The Harvard Drug Group LLC
Not sure what you're entitled to? Read our guide: what to do if your product is recalled.
Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
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CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Failed Dissolution Specifications
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