Potassium Chloride Injection, Solution
FDA Recall NDC 0990-7074
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 4 recorded enforcement report(s) associated with Potassium Chloride (NDC 0990-7074). A significant event, classified as Class I, was initiated on Oct 29, 2025 by Icu Medical Inc.. The reported reason for this action was: "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"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class I Ongoing
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
Oct 29, 2025
Nov 26, 2025
21,696 50mL flexible containers
Recall Profile & Regulatory Data
Event ID
97888
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
Otsuka ICU Medical LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
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
Batch or Lot Expiration Information
Lot# 1030613, Exp Date: 09/30/2026
Affected Packages Involved in this Recall
0990-7074-26Product
0990-7075-14Product
0990-7075-26Product
0990-7077-14Product
0990-7077-26Product
Class I Ongoing
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
Oct 29, 2025
Nov 26, 2025
N/A
Recall Profile & Regulatory Data
Event ID
97888
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
Otsuka ICU Medical LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Product Description
POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26
Batch or Lot Expiration Information
Lot# 1030613, Exp Date: 09/30/2026
Affected Packages Involved in this Recall
0990-7074-26Product
0990-7075-14Product
0990-7075-26Product
0990-7077-14Product
0990-7077-26Product
Class I Ongoing
Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
Feb 13, 2025
Mar 19, 2025
unknown
Recall Profile & Regulatory Data
Event ID
96250
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
ICU Medical, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26; Bar Code (01)00309907074269
Batch or Lot Expiration Information
Lot# Lot 1023172, Exp Date: 31 January 2026
Affected Packages Involved in this Recall
0990-7074-26Product
0990-7075-14Product
0990-7075-26Product
0990-7077-14Product
0990-7077-26Product
0030990707Product
Class I Ongoing
Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.
Feb 13, 2025
Mar 19, 2025
67,488 flexible containers
Recall Profile & Regulatory Data
Event ID
96250
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
ICU Medical, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7075-26; Bar Code Flexible container (01) 00309907075266; Case (01)30309907075267
Batch or Lot Expiration Information
Lot# Lot 1023172, Exp Date: 31 January 2026
Affected Packages Involved in this Recall
0990-7074-26Product
0990-7075-14Product
0990-7075-26Product
0990-7077-14Product
0990-7077-26Product
0030990707Product
3030990707Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
