# FDA recall D-0649-2024

> **Baxter Healthcare Corporation** · Class I · drug recall initiated 2024-08-01.

## Product

Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Single Dose Container, Rx Only, Baxter USA,  NDC 0338-0433-04

## Reason for recall

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0649-2024
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-08-01
- **Report date:** 2024-09-11

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0649-2024

## Citation

> AI Analytics. FDA recall D-0649-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0649-2024. Source: US FDA. Licensed CC0.

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