Potassium Chloride Injection Recalled for Incorrect Strength on Overwrap Label
A Potassium Chloride prescription injection has been recalled due to a labeling error on the overwrap. The label may incorrectly identify the product as 10 mEq instead of 20 mEq.
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: This is an FDA Class I recall, which meets the rubric criterion for Critical severity.
Plain-English summary
Otsuka ICU Medical LLC is recalling Potassium Chloride Inj., 20 mEq in 50 mL flexible containers due to a labeling error on the overwrap. The overwrap label may incorrectly identify the product as Potassium Chloride Inj. 10 mEq instead of 20 mEq.
The recalled product is a highly concentrated injectable solution containing 400 mEq/L, intended for intravenous administration. Lot number 1030613 (expiration date 09/30/2026) is affected.
Approximately 21,696 units were distributed nationwide. Healthcare facilities and pharmacies that received this recalled lot should be aware of the labeling discrepancy. The FDA classified this as a Class I recall.
The recalled product
- Product
- POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
- Brand
- POTASSIUM CHLORIDE
- Manufacturer
- Otsuka ICU Medical LLC
- Category
- Drug — Injectable
- Hazard
- mis-labeling
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.
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