Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Pac
Summary
The FDA issued a Class II for Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose by The Harvard Drug Group LLC. Reason: Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells..
Details
Source
Drug Recall
External ID
D-0493-2026
Action Date
2026-04-29
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot#: Lot N02406, Exp 10/31/2026; Lot N02845, Exp 12/31/2026
Quantity Affected: 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.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-09
Company
Dublin, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 82 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
The Harvard Drug Group LLC has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (The Harvard Drug Group LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does The Harvard Drug Group LLC have FDA actions?
The Harvard Drug Group LLC has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0493-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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