# FDA recall D-0143-2026

> **Otsuka ICU Medical LLC** · Class II · drug recall initiated 2025-10-27.

## Product

0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37

## Reason for recall

Lack of Assurance of Sterility: Potential for flexible container leaks.

## Distribution

Distributed Nationwide in the USA.

## Key facts

- **Recall number:** D-0143-2026
- **Recalling firm:** Otsuka ICU Medical LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-10-27
- **Report date:** 2025-11-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Austin, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0143-2026

## Citation

> AI Analytics. FDA recall D-0143-2026. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/D-0143-2026. Source: US FDA. Licensed CC0.

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