FDA Drugs recall ·
Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram… recall
- Recall number
- D-0493-2026
- Date
- (initiated April 9, 2026)
- Company / brand
- The Harvard Drug Group LLC
7000 Cardinal Pl, Dublin, OH, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2,238 5 x 10 unit dose cartons
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot#: Lot N02406, Exp 10/31/2026; Lot N02845, Exp 12/31/2026
Distribution
Nationwide in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0493-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.