FDA Drugs recall ·
POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0180-2026
- Date
- (initiated October 29, 2025)
- Company / brand
- Otsuka ICU Medical LLC
3900 Howard Ln, Austin, TX, United States - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 21,696 50mL flexible containers
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
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
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # 1030613, Exp Date: 09/30/2026
Distribution
US Nationwide.
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0180-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.