HIGH

Walgreens Saline Nasal Spray With Xylitol Recalled for Microbial Contamination (41,328 Bottles, 2025

Walgreens Saline Nasal Spray With Xylitol, distributed by Walgreens Co., is recalled nationwide. The product was found with microbial contamination, specifically Pseudomonas lactis, in a non-sterile formulation. Consumers should stop using the product immediately and contact Medical Products Laboratories, Inc. for guidance or consult a clinician.

Quick Facts at a Glance

Recall Date
November 12, 2025
Hazard Level
HIGH
Brand
Medical Products Laboratories
Category
Health & Personal Care
Sold At
Walgreens
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Medical Products Laboratories, Inc. or your healthcare provider for guidance. Notification method: Letter

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About This Product

Saline nasal spray used to moisten nasal passages and relieve congestion. Often used by adults and children under guidance.

Why This Is Dangerous

Non-sterile products can harbor bacteria. Inhalation or contact with contaminated solution may cause infections or irritation.

Industry Context

This recall is not described as part of a broader pattern in the provided information.

Real-World Impact

Consumers must stop using the affected bottles immediately. The recall affects over 41,000 bottles nationwide, with potential impact on households and healthcare providers.

Practical Guidance

How to identify if yours is affected

  1. Verify NDC 0363-3114-01 on the product label
  2. Check Lot numbers 71409 or 71861
  3. Note expiration dates 02/28/2027 or 08/31/2027

Where to find product info

Recall notice and FDA Enforcement Report; recall letter from manufacturer

What timeline to expect

No specific refund/replacement timeline is provided. Follow recall letter for next steps.

If the manufacturer is unresponsive

  • Contact FDA Consumer Complaint Coordinator in your region
  • Keep records of all communications with the manufacturer and retailer

How to prevent similar issues

  • Check NDC and lot numbers before use of any saline spray
  • Buy from reputable sources and verify expiration dates
  • Dispose of recalled products according to the recall notice

Documentation advice

Keep the recall letter, photos of the bottle, purchase receipts, and all correspondence with the manufacturer for records

Product Details

NDC: 0363-3114-01; Size: 1.5 oz (45 mL); Quantity: 41,328 bottles; Lot numbers: 71409 and 71861; Expirations: 02/28/2027 and 08/31/2027; Distribution: Nationwide USA; Distributor: Walgreens Co., 200 Wilmot Rd., Deerfield, IL 60015; Manufacturer: Medical Products Laboratories, Inc.; Recall date: 2025-11-12; Status: ACTIVE

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 41,328 bottles affected
  • NDC 0363-3114-01
  • Lot 71409 and Lot 71861
  • Expirations: 02/28/2027 and 08/31/2027
  • Distributed nationwide in the 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
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
71409
71861
Affected States
ALL
Report Date
December 3, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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