# FDA recall D-0810-2026

> **Baxter Healthcare Corporation** · Class II · drug recall initiated 2026-08-06.

## Product

Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per 100 mL (4 mcg/mL) in Galaxy 100 mL Single Dose Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-9557-12.

## Reason for recall

CGMP Deviations

## Distribution

US Nationwide; Puerto Rico; and Chile.

## Key facts

- **Recall number:** D-0810-2026
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-08-06
- **Report date:** 2026-09-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0810-2026

## Citation

> MORVS. FDA recall D-0810-2026. Retrieved 2026-10-12 from https://api.morvs.ai/recall/D-0810-2026. Source: US FDA. Licensed CC0.

---

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