# FDA recall D-0268-2025

> **ICU Medical, Inc.** · Class I · drug recall initiated 2025-02-13.

## Product

POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26; Bar Code (01)00309907074269

## Reason for recall

Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0268-2025
- **Recalling firm:** ICU Medical, Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-02-13
- **Report date:** 2025-03-19

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0268-2025

## Citation

> AI Analytics. FDA recall D-0268-2025. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/D-0268-2025. Source: US FDA. Licensed CC0.

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