HIGHFDA DRUG

0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA, LLC ("Fresenius Kabi"), IL 60047, Unit of...

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
March 11, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
March 11, 2026
Hazard Level
HIGH
Brands
SODIUM CHLORIDE, Fresenius Kabi USA, LLC
Geographic Scope
1 states

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
SODIUM CHLORIDE, Fresenius Kabi USA, LLC
Model numbers
Batch# 23DU10004, Exp Date: 04/30/2026, Batch# 23HU10006, Exp Date: 06/30/2026.
UPC codes
65219-328, 65219-432, 65219-432-20, 65219-432-85, 65219-328-10, 65219-328-50
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    March 11, 2026

  2. Reported by FDA DRUG

    April 15, 2026

  3. RecallRadar source check

    April 22, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Lack of Assurance of Sterility

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Fresenius Kabi USA, LLC or your healthcare provider for guidance. Notification method: Letter

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Full Description

0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA, LLC ("Fresenius Kabi"), IL 60047, Unit of Use NDC: 65219-432-20, Unit of Sale NDC Number: 65219-432-85.. Generic: SODIUM CHLORIDE; Brand: SODIUM CHLORIDE. Reason: Lack of Assurance of Sterility. Classification: Class II. Distribution: US Nationwide , Alaska, and Puerto Rico.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
Batch# 23DU10004
Exp Date: 04/30/2026
Batch# 23HU10006
Exp Date: 06/30/2026.
UPC Codes
65219-328
65219-432
65219-432-20
+3 more
Affected States
ALL
Report Date
April 15, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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