FDA recall, , Moderate risk
Major Pharmaceuticals Omega-3-Acid Ethyl Esters Capsules
Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram failed capsule specifications for loss on drying of capsule shells.
Summary by Recall Canary from the FDA notice
What happened
The Harvard Drug Group LLC, based in Dublin, Ohio, is recalling 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. The recall was initiated on April 9, 2026, due to out of specification results obtained during routine stability testing for loss on drying of capsule shells. The product was distributed nationwide in the USA.
The recall involves 2,238 5 x 10 unit dose cartons. The FDA added the recall to its Enforcement Report on April 17, 2026, and classified it on April 24, 2026. The recall was included in the FDA's weekly enforcement report on April 29, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram
- NDC
- 0904-7495-06
- Lot code
- N02406
- N02845
Recall details
- Company began the recall
- Sold in
Nationwide in the USA
- Company
- The Harvard Drug Group LLCDublin, Ohio
- Hazard
- Quality testing problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98763
- Recall number
- D-0493-2026
- Quantity recalled
- 2,238 5 x 10 unit dose cartons
All recalls from The Harvard Drug Group LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
