POTASSIUM CHLORIDE
Recalling Firm / Manufacturer: Otsuka ICU Medical LLC
(Austin, TX, United States)
FDA Recall Number: D-0180-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
POTASSIUM CHLORIDE
Generic Name
POTASSIUM CHLORIDE
Active Substance(s)
Potassium Chloride
Administration Route
Intravenous
National Drug Code (NDC)
0990-7074
Total Quantity Recalled
21,696 50mL flexible containers
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
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
Full Product Description
Packaging specifications and labeling details
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
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class I
Current Action Status
Ongoing
FDA Enforcement Report Date
November 26, 2025
Firm Initiation Date
October 29, 2025
FDA Classification Date
Nov 24, 2025
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot # 1030613, Exp Date: 09/30/2026
Distribution Information
Geographic scope of affected shipments
US Nationwide.
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
⚠️ Immediate Action Required — Patient Notice
According to official FDA guidelines for Class I recalls, patients using affected lots should stop taking this product immediately and contact their physician or pharmacist for an appropriate alternative. Do not dispose of medication until instructed by your pharmacy.
Healthcare Provider & Pharmacy Notice
Quarantine affected inventory immediately. Contact patients who were dispensed recalled lots to arrange replacement. Report any adverse reactions directly to the FDA MedWatch Safety Information Program.
Related Questo Medical Knowledge
Clinical cases and condition overviews related to this medication
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0180-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508609UTCC