Quick Facts at a Glance
- Recall Date
- April 9, 2026
- Hazard Level
- HIGH
- Brands
- OMEGA-3-ACID ETHYL ESTERS, Major Pharmaceuticals
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- OMEGA-3-ACID ETHYL ESTERS, Major Pharmaceuticals
- Model numbers
- Lot#: Lot N02406, Exp 10/31/2026, Lot N02845, Exp 12/31/2026
- UPC codes
- 0904-7495, 0904-7495-06
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
April 9, 2026
Reported by FDA DRUG
April 29, 2026
RecallRadar source check
May 6, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact The Harvard Drug Group LLC or your healthcare provider for guidance. Notification method: Letter
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Full Description
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. Generic: OMEGA-3-ACID ETHYL ESTERS CAPSULES; Brand: OMEGA-3-ACID ETHYL ESTERS. Reason: Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.. Classification: Class II. Quantity: 2,238 5 x 10 unit dose cartons. Distribution: Nationwide in the USA
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
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