Why it was recalled
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Product 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
Lot numbers, UPCs & expiration codes
Lot#: Lot N02406, Exp 10/31/2026; Lot N02845, Exp 12/31/2026
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0493-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 9, 2026
- FDA report date
- Apr 29, 2026
- Quantity
- 2,238 5 x 10 unit dose cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Harvard Drug Group LLC
Original FDA data
Every field from FDA enforcement report D-0493-2026, exactly as published.
Show all FDA fields
- City
- Dublin
- State
- OH
- Status
- Ongoing
- Country
- United States
- Event ID
- 98763
- Address
- 7000 Cardinal Pl
- Code information
- Lot#: Lot N02406, Exp 10/31/2026; Lot N02845, Exp 12/31/2026
- Postal code
- 43017-1091
- Report date
- Apr 29, 2026
- Product type
- Drugs
- Recall number
- D-0493-2026
- Classification
- Class II
- Recalling firm
- The Harvard Drug Group LLC
- Product quantity
- 2,238 5 x 10 unit dose cartons
- Reason for recall
- Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 9, 2026
- Initial firm notification
- Letter
- Center classification date
- Apr 24, 2026