# FDA recall D-0447-2026

> **GE Healthcare Ireland Limited** · Class II · drug recall initiated 2026-03-24.

## Product

GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63.

## Reason for recall

Presence of particulate matter

## Distribution

U.S. Nationwide.

## Key facts

- **Recall number:** D-0447-2026
- **Recalling firm:** GE Healthcare Ireland Limited
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-03-24
- **Report date:** 2026-04-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Carrigtwohill, Ireland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0447-2026

## Citation

> AI Analytics. FDA recall D-0447-2026. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0447-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*