Otsuka Icu Medical recalls
Otsuka Icu Medical appears in 3 official U.S. recall notices indexed by RecallRadar, most recently on 2025-11-26.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 3 |
|---|---|
| Published | 2025-11-05 to 2025-11-26 |
| By agency | FDA Drug (3) |
| By classification | Class I (2), Class II (1) |
| By status | ongoing (3) |
| Distribution named in notices | US |
Recalls
- POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest,…
FDA Drug · Class I · 2025-11-26 · Otsuka Icu Medical
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 - POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest,…
FDA Drug · Class I · 2025-11-26 · Otsuka Icu Medical
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 - 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
FDA Drug · Class II · 2025-11-05 · Otsuka Icu Medical
Reason: Lack of Assurance of Sterility: Potential for flexible container leaks.