Sodium Chloride Injection, Solution
FDA Recall NDC 0990-7985
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Sodium Chloride (NDC 0990-7985). A significant event, classified as Class II, was initiated on Oct 27, 2025 by Icu Medical Inc.. The reported reason for this action was: "Lack of Assurance of Sterility: Potential for flexible container leaks."
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 II Ongoing
Lack of Assurance of Sterility: Potential for flexible container leaks.
Oct 27, 2025
Nov 05, 2025
509,360 100 mL bags
Recall Profile & Regulatory Data
Event ID
97841
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Otsuka ICU Medical LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA.
Product Description
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Batch or Lot Expiration Information
Lot# 1029921, Exp Date: 28 February 2027
Affected Packages Involved in this Recall
0990-7730-36Product
0990-7730-37Product
0990-7983-61Product
0990-7983-02Product
0990-7983-03Product
0990-7983-09Product
0990-7983-55Product
0990-7983-53Product
0990-7984-37Product
0990-7984-20Product
0990-7984-13Product
0990-7984-23Product
0990-7984-36Product
0990-7985-02Product
0990-7985-03Product
0990-7985-09Product
Class II Ongoing
Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
Nov 09, 2022
Nov 23, 2022
137,120 bags
Recall Profile & Regulatory Data
Event ID
91113
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
ICU Medical Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Batch or Lot Expiration Information
Lot# Lot: 5829936, Exp. MAR 31 2024
Affected Packages Involved in this Recall
0990-7730-36Product
0990-7730-37Product
0990-7983-61Product
0990-7983-02Product
0990-7983-03Product
0990-7983-09Product
0990-7983-55Product
0990-7983-53Product
0990-7984-37Product
0990-7984-20Product
0990-7984-13Product
0990-7984-23Product
0990-7984-36Product
0990-7985-02Product
0990-7985-03Product
0990-7985-09Product
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.
