POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical,
Summary
The FDA issued a Class I for POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concen by Otsuka ICU Medical LLC. Reason: Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASS.
Details
Source
Drug Recall
External ID
D-0180-2026
Action Date
2025-11-26
Status
Ongoing
Category
drug
Product Description
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
Lot/Code Info: Lot # 1030613, Exp Date: 09/30/2026
Quantity Affected: 21,696 50mL flexible containers
Reason for Recall
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
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-29
Company
Austin, TX
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 52 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Otsuka ICU Medical LLC has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Otsuka ICU Medical LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Otsuka ICU Medical LLC have FDA actions?
Otsuka ICU Medical LLC has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0180-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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