HIGH

B. Braun Lactated Ringers Injection 46,032 Containers Recalled Over Particulate Matter

B. Braun Medical recalled 46,032 containers of Lactated Ringers Injection USP sold nationwide in the United States. The recall cites the presence of particulate matter in the 1000 mL IV solution. Consumers should stop using the product immediately and contact their healthcare provider or B. Braun for guidance.

Quick Facts at a Glance

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

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

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About This Product

Lactated Ringers Injection USP is a sterile IV solution used for fluid and electrolyte replenishment in clinical settings.

Why This Is Dangerous

Particulate matter in IV solutions can lead to adverse reactions if administered intravenously. This can include vascular irritation or embolic events depending on the particulates.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Affects medical facilities and patients relying on IV therapy; may cause delays in care and require verification of safe inventory.

Practical Guidance

How to identify if yours is affected

  1. Check NDC 0264-7750-07 on the product label.
  2. Inspect for Lot J4S807 and Exp 5/31/2027.
  3. Confirm 1000 mL container size.

Where to find product info

FDA recall page and manufacturer notices. Serial/lot codes on the IV bag label.

What timeline to expect

Refund/replacement timelines vary; hospital purchases handled through procurement channels; consumer timelines through hospital or distributor.

If the manufacturer is unresponsive

  • Escalate to hospital infection control or CPSC if needed
  • File a consumer complaint with FDA/CDC if necessary

How to prevent similar issues

  • Verify lot numbers before administration.
  • Coordinate with pharmacy or supplier for safe inventory.
  • Do not use recalled lots in any patient care.

Documentation advice

Keep recall notices, photos of labels, purchase records, and any correspondence with suppliers.

Product Details

Product: Lactated Ringers Injection USP, 1000 mL container. Brand: Lactated Ringers. Manufacturer: B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA. NDC: 0264-7750-07. Quantity: 46,032 containers. Distribution: Nationwide (USA). Lot: J4S807. Expiration: 5/31/2027.

Reported Incidents

No injuries or incidents have been reported in the provided recall notice.

Key Facts

  • 46,032 containers recalled
  • NDC 0264-7750-07
  • Lot J4S807
  • Exp 5/31/2027
  • National distribution in the USA
  • No injuries reported

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
GENERALPREGNANTELDERLYPREGNANTINFANTSCHILDRENPETS
Injury Types
ELECTRICALPOISONINGBURNLACERATIONOTHER

Product Details

Model Numbers
Lot J4S807 Exp 5/31/2027
UPC Codes
0264-7750
0264-7750-07
Affected States
ALL
Report Date
September 10, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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