# FDA recall D-0267-2025

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

## Product

POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7075-26; Bar Code Flexible container (01) 00309907075266; Case (01)30309907075267

## Reason for recall

Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0267-2025
- **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-0267-2025

## Citation

> AI Analytics. FDA recall D-0267-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0267-2025. Source: US FDA. Licensed CC0.

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