FDA Recall D-0493-2026

The Harvard Drug Group LLC · Dublin, OH

Class II Ongoing 35 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lot#: Lot N02406, Exp 10/31/2026; Lot N02845, Exp 12/31/2026

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.

Recall record

Recall number: D-0493-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2026-04-09
Classified by FDA Center: 2026-04-24
FDA published: 2026-04-29
Recalling firm: The Harvard Drug Group LLC
Firm location: Dublin, OH

Drug identification

Brand name(s): OMEGA-3-ACID ETHYL ESTERS
Generic name(s): OMEGA-3-ACID ETHYL ESTERS CAPSULES
Manufacturer(s): Major Pharmaceuticals
NDC(s): 0904-7495
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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