April 2026 FDA Recall Omega-3-acid Ethyl Esters by The Harvard Drug Group Llc
D-0493-2026 - Failed Capsule Specifications

This Class II drug recall was voluntarily initiated by The Harvard Drug Group Llc on April 9, 2026 for the product Omega-3-acid Ethyl Esters. The FDA reported the reason for recall as failed capsule specifications. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0493-2026

Reason for Recall
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Initiated
04-09-2026
Reported
04-29-2026
Quantity
2,238 5 x 10 unit dose cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
98763
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Harvard Drug Group LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

0904-7495-06 Omega-3-acid Ethyl Esters