# FDA recall D-0814-2026

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

## Product

Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextrose, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in the USA, NDC 43066-360-20.

## Reason for recall

CGMP Deviations

## Distribution

US Nationwide; Puerto Rico; and Chile.

## Key facts

- **Recall number:** D-0814-2026
- **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-0814-2026

## Citation

> MORVS. FDA recall D-0814-2026. Retrieved 2026-10-19 from https://api.morvs.ai/recall/D-0814-2026. Source: US FDA. Licensed CC0.

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