← FDA ENFORCEMENT
D-0493-2026Class II

The Harvard Drug Group LLC

Recalling firm
The Harvard Drug Group LLC
Product type
Drug
Status
Ongoing
Report date
2026-04-29
Distribution
Nationwide in the USA
Firm state
OH
Product quantity
2,238 5 x 10 unit dose cartons
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.

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

Code / lot info

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

Other recalls SPEQ maps to Validation & Qualification
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See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.