FDAHealthApril 9, 2026
The Harvard Drug Group LLC — 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, In
⚠️ Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 9, 2026
Nationwide in the USA
What's affected?
- 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
- Lot code
- Lot
Additional details
Lot#: Lot N02406, Exp 10/31/2026; Lot N02845, Exp 12/31/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 2,238 5 x 10 unit dose cartons.
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