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

FDA recall notice · announced April 29, 2026 · The Harvard Drug Group

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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

Reason for recall

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

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot#: Lot N02406, Exp 10/31/2026; Lot N02845, Exp 12/31/2026
Quantity: 2,238 5 x 10 unit dose cartons
Status: Ongoing
Products in this recall event:
- 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: 09 (D-0493-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.