Austin, TX, United States
Otsuka ICU Medical LLC recalls
2 recalls recorded since 2018, most recently on 29 October 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)1
Ongoing Class I Drugs
- Recall started
- 29 October 2025
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0181-2026, D-0180-2026
- POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26
- 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
Ongoing Class II Drugs
- Recall started
- 27 October 2025
- Reason
- Lack of Assurance of Sterility: Potential for flexible container leaks.
- Distribution
- Distributed Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0143-2026
- 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.