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B. Braun Sodium Chloride Injection 1000 mL Recalled nationwide for particulates (Class I)

B. Braun Medical Inc. recalls 47,148 containers of 0.9% Sodium Chloride Injection USP nationwide after detecting particulate matter. The Class I recall affects bottles with NDC 0264-7800-09. Stop using and contact providers for guidance.

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
August 18, 2025
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

Recall Date
August 18, 2025
Hazard Level
HIGH
Brands
B. Braun Medical Inc., Sodium Chloride
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL, PREGNANT, ELDERLY

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
B. Braun Medical Inc., Sodium Chloride
Product type
Intravenous Solution (Sodium Chloride Injection)
Model numbers
Lot #: V3K770
UPC codes
0264-7800, 0264-7800-09
Sizes
1000 mL
Sold at
Unknown
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    August 18, 2025

  2. Reported by FDA DRUG

    September 10, 2025

  3. RecallRadar source check

    April 18, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Presence of Particulate Matter.

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact B BRAUN MEDICAL INC or your healthcare provider for guidance. Notification method: Letter

About This Product

0.9% Sodium Chloride Injection USP is a sterile IV fluid used to replenish lost fluids and electrolytes. It is administered in hospitals and clinics.

Why This Is Dangerous

Particulate matter in IV solution can embolize or cause blockages, leading to severe complications or death if infused.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Hospitals and clinics must halt use of the affected lot and manage inventory to prevent patient exposure; potential impact on patient safety and supply chains.

Practical Guidance

How to identify if yours is affected

  1. Check NDC 0264-7800-09 on the container label.
  2. Match Lot number V3K770 and Expiration 01/31/2026.
  3. Verify 1000 mL bag size and Rx-only labeling.

Where to find product info

FDA enforcement report D-0628-2025 and official recall notices from B. Braun Medical Inc.

What timeline to expect

Remedies typically processed within 4-6 weeks; follow vendor and hospital policy for returns or replacements.

If the manufacturer is unresponsive

  • Escalate to hospital risk management
  • File a report with supplier trading partners
  • Contact FDA for guidance if manufacturer is unresponsive

How to prevent similar issues

  • Implement lot-traceability checks at receiving
  • Stock rotation to ensure oldest lots are used first
  • Verify NDC before administration
  • Maintain strict IV compounding protocols

Documentation advice

Retain recall notice, lot number, NDC, and correspondence with manufacturer for records

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Product Details

Model numbers: Lot # V3K770. Expiration: 01/31/2026. Quantity: 47,148 containers. Sold nationwide in the USA. Form: 1000 mL IV bags. Route: Intravenous use. Manufacturer: B. Braun Medical Inc., Bethlehem, PA 18018-3524 USA. NDC: 0264-7800-09.

Reported Incidents

No specific injuries or incidents are disclosed in the provided data.

Key Facts

  • Class I recall
  • Lot # V3K770
  • Nationwide distribution in USA

Safety Guide

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

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALPREGNANTELDERLYPETSPREGNANT
Injury Types
POISONINGELECTRICALLACERATIONSUFFOCATIONOTHER

Product Classification

Product Details

Model Numbers
Lot #: V3K770
UPC Codes
0264-7800
0264-7800-09
Affected States
ALL
Report Date
September 10, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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