Harvard Drug Group Omega-3 Capsules Recall: Failed Capsule Specifications
Harvard Drug Group recalls Omega-3 Acid Ethyl Esters capsules due to failed stability testing for loss on drying. This may affect product quality but does not pose immediate safety risks.
Lower-risk recall
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Contact the company
What happened, in plain English
Harvard Drug Group is recalling Omega-3 Acid Ethyl Esters capsules that failed stability testing for loss on drying. This issue does not pose a safety risk but could affect product quality. Read more at govinfonow.com/recall/31350-harvard-drug-group-omega-3-capsules-recall-failed-capsule-specifications.
Source Summary by GovInfoNow · govinfonow.com/recall/31350-harvard-drug-group-omega-3-capsules-recall-failed-capsule-specifications · Updated August 17, 2026 · FDA enforcement record: FDA #D-0493-2026
Cite this page
“Harvard Drug Group Omega-3 Capsules Recall: Failed Capsule Specifications.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31350-harvard-drug-group-omega-3-capsules-recall-failed-capsule-specifications. Based on FDA recall #D-0493-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0493-2026%22&limit=1).
Why it’s dangerous
The capsules failed stability testing for loss on drying, meaning the shell material may degrade over time. This could lead to inconsistent product quality but does not cause immediate safety hazards.
Who’s affected
People who have the specific Omega-3 capsules with NDC 0904-7495-06 and lots N02406 or N02845 are affected. Those using prescription-only capsules for health purposes are most at risk.
How to tell if you have this one
Check for the NDC code 0904-7495-06 and lot numbers N02406 (expiring 10/31/2026) or N02845 (expiring 12/31/2026) on the packaging.
- Brand
Harvard Drug Group- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC code 0904-7495-06 and lot numbers N02406 or N02845 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 20 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0493-2026 (April 9, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0493-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.