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CLASS II · ModerateFDA

The Harvard Drug Group LLC recalls Omega-3-Acid

📅 Apr 9, 2026 · 📍 Nationwide
Recalling company
The Harvard Drug Group LLC
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
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Apr 9, 2026
Reported
Apr 29, 2026
Distribution
Nationwide in the USA
Status
Ongoing
Quantity
2,238 5 x 10 unit dose cartons
Lot / codes
Lot#: Lot N02406, Exp 10/31/2026; Lot N02845, Exp 12/31/2026
Company location
Dublin, OH
Recall type
Voluntary: Firm initiated
Recall number
D-0493-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0493-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.