# FDA recall D-0493-2026

> **The Harvard Drug Group LLC** · Class II · drug recall initiated 2026-04-09.

## 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

## 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

## Key facts

- **Recall number:** D-0493-2026
- **Recalling firm:** The Harvard Drug Group LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-04-09
- **Report date:** 2026-04-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dublin, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0493-2026

## Citation

> AI Analytics. FDA recall D-0493-2026. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/D-0493-2026. Source: US FDA. Licensed CC0.

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