# FDA recall D-0180-2026

> **Otsuka ICU Medical LLC** · Class I · drug recall initiated 2025-10-29.

## Product

POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7077-14

## Reason for recall

Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq

## Distribution

US Nationwide.

## Key facts

- **Recall number:** D-0180-2026
- **Recalling firm:** Otsuka ICU Medical LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-10-29
- **Report date:** 2025-11-26

- **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-0180-2026

## Citation

> AI Analytics. FDA recall D-0180-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0180-2026. Source: US FDA. Licensed CC0.

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