Recalls / Class I
Class ID-0180-2026
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Brand name
- Potassium Chloride
- Generic name
- Potassium Chloride
- Active ingredient
- Potassium Chloride
- Route
- Intravenous
- NDCs
- 0990-7074, 0990-7075, 0990-7077
- FDA application
- NDA020161
- Affected lot / code info
- Lot # 1030613, Exp Date: 09/30/2026
Why it was 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
Recalling firm
- Firm
- Otsuka ICU Medical LLC
- Manufacturer
- ICU Medical Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3900 Howard Ln, Austin, Texas 78728-6515
Distribution
- Quantity
- 21,696 50mL flexible containers
- Distribution pattern
- US Nationwide.
Timeline
- Recall initiated
- 2025-10-29
- FDA classified
- 2025-11-24
- Posted by FDA
- 2025-11-26
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0180-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.