Potassium Chloride Injection Strength Mislabeled on Packaging Overwrap
ICU Medical recalls Potassium Chloride Injection (lot 1023172) whose overwrap labeled as 10 mEq may contain 20 mEq containers, creating overdose risk. Product distributed nationwide.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA classified this as Class I, which requires a minimum severity score of 4 per the rubric. The mislabeling of potassium chloride strength (10 mEq labeled but 20 mEq contained) creates serious risk of medication error and patient harm, despite no illnesses currently reported.
Plain-English summary
ICU Medical, Inc. is recalling Potassium Chloride Injection, NDC 0990-7074-26, a prescription intravenous medication. The product's overwrap is labeled as Potassium Chloride Injection 10 mEq in 100 mL flexible container, but some containers in affected lot 1023172 contain 20 mEq instead.
This labeling discrepancy creates a serious risk of medication error. Healthcare workers or patients may administer the incorrect strength based on the label, potentially resulting in a dose double what was intended. Potassium chloride is a critical electrolyte supplement, and dosing errors can lead to serious patient harm.
The affected product, lot 1023172 with expiration date January 31, 2026, has been distributed nationwide throughout the United States.
The recalled product
- Product
- POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
- Brand
- POTASSIUM CHLORIDE
- Manufacturer
- ICU Medical, Inc.
- Category
- Drug — Intravenous Electrolyte
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 1023172
- Exp Date: 31 January 2026
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by ICU Medical, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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