Omega-3-acid Ethyl Esters Capsule, Liquid Filled
FDA Recall NDC 0904-7495
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Omega-3-acid Ethyl Esters (NDC 0904-7495). A significant event, classified as Class II, was initiated on Apr 09, 2026 by Major Pharmaceuticals. The reported reason for this action was: "Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Apr 09, 2026
Apr 29, 2026
2,238 5 x 10 unit dose cartons
Recall Profile & Regulatory Data
Event ID
98763
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
The Harvard Drug Group LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
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
0904-7495-06Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
