Harvard Drug Group recalls Omega-3-Acid Ethyl Esters 1 gram capsules because capsule shells failed testing
During routine stability testing, the capsule shells gave out-of-specification results for loss on drying, meaning the capsules did not meet the required quality standard.
What to do
Check whether you have Major Pharmaceuticals Omega-3-Acid Ethyl Esters Capsules, 1 gram, 50-capsule cartons, NDC 0904-7495-06. Read the official notice for details on what to do next.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- 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
- Company
- The Harvard Drug Group LLC
- Hazard
- Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
- Units
- 2,238 5 x 10 unit dose cartons
- Where sold
- Nationwide in the USA
- FDA classification
- Class II · Ongoing
- Classified by FDA
- April 24, 2026
- Recall started
- April 9, 2026
- FDA enforcement report
- April 29, 2026
- Identifiers
- Codes: Lot#: Lot N02406, Exp 10/31/2026; Lot N02845, Exp 12/31/2026
- FDA recall number: D-0493-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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.
- Classification
- Class II (Ongoing)
- Distribution
- Nationwide in the USA
- Quantity
- 2,238 5 x 10 unit dose cartons
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