Reported Apr 29, 2026 · Ongoing

Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only,…

The Harvard Drug Group LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: The Harvard Drug Group LLC · 7000 Cardinal Pl · Dublin, OH · 43017-1091

Is this the product you have?

  • 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 byMajor Pharmaceuticals, Indianapolis, IN 46288
  • NDC0904-7495-06
Lot codes and dates
    • Lot#: Lot N02406
    • Exp 10/31/2026
    • Lot N02845
    • Exp 12/31/2026
Amount recalled
2,238 5 x 10 unit dose cartons

Where it was sold

  • Nationwide

Why it was recalled

Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 3:34 PM UTC

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