Concentrated potassium chloride recalled over an understated strength on the overwrap
Otsuka ICU Medical is recalling 21,696 containers of Potassium Chloride Injection 20 mEq in 50 mL because the overwrap may state 10 mEq. The FDA classified it Class I.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the top severity regardless of other factors.
Plain-English summary
Potassium Chloride Injection, 20 mEq total in a 50 mL flexible container, highly concentrated at 400 mEq/L, from ICU Medical of Lake Forest, Illinois, NDC 0990-7077-14, is being recalled for a label error on the declared strength.
The overwrap label may incorrectly identify the product as Potassium Chloride Injection 10 mEq instead of Potassium Chloride Injection 20 mEq.
The recall covers 21,696 50 mL flexible containers from lot 1030613, expiring 30 September 2026. The product was distributed nationwide in the United States.
The FDA has classified this as a Class I recall, its most serious category, used where there is a reasonable probability of serious health consequences or death. Potassium chloride is given intravenously and dosed precisely, so a container holding twice the labelled amount is a serious risk. Facilities should quarantine lot 1030613 immediately and follow the firm's instructions.
The recalled product
- Product
- POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
- Brand
- POTASSIUM CHLORIDE
- Manufacturer
- Otsuka ICU Medical LLC
- Category
- Drug — Intravenous solution
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 # 1030613
- Exp Date: 09/30/2026
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Otsuka ICU Medical LLC 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
Same brand · POTASSIUM CHLORIDE
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