FDAFDA · Food and drugs·Recall number D-0493-2026
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
Published April 29, 2026 · Recall initiated: April 9, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- OMEGA-3-ACID ETHYL ESTERS
- Manufacturer
- The Harvard Drug Group LLC
- Distributor
- Nationwide in the USA
- Lot
- Lot#: Lot N02406, Exp 10/31/2026; Lot N02845, Exp 12/31/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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