There’s something in the Spray! — P. lactis Contamination and How Better Monitoring Can Prevent Outbreaks

Nov 28

Saline nasal sprays are widely used for congestion relief, dry sinuses, and everyday comfort—especially during cold and flu season. But recent recall alerts have brought attention to an important issue that often goes unnoticed: microbial contamination in non-sterile over-the-counter products.

A large batch of saline spray was recalled in the United States after routine quality checks detected contamination with a naturally occurring waterborne bacterium. While the affected lots were quickly pulled from shelves, the incident highlights why strong microbial monitoring is essential in manufacturing environments.

Below, we break down what you need to know and how modern biosurveillance technology could help prevent similar events in the future.

What Happened?

The FDA announced a nationwide Class II recall after testing revealed that a saline nasal spray was contaminated with Pseudomonas lactis, a microorganism that should not be present in products intended for nasal use. Approximately 40,000+ bottles across two production lots were affected, prompting immediate removal from distribution and consumer advisories (FDA, 2025).

A Class II recall indicates that exposure to the product may cause temporary or medically reversible health effects, especially in individuals with underlying vulnerabilities.

Meet the Microbe: Pseudomonas lactis

Scientific literature (Olofinsae et al., 2022) shows that Pseudomonas lactis is a Gram-negative, non-lactose-fermenting bacterium originally identified in cold environments such as refrigerated foods and raw milk. Studies also report its presence in:

Water sources
Soil
Produce
Animal environments (including poultry and dairy contexts)
pseudomonas lactis article

Although P. lactis is not one of the most common human pathogens, its presence in products that contact mucous membranes is concerning because it can opportunistically infect vulnerable individuals.

Where This Bacterium Is Commonly Found

Based on available research, P. lactis is typically associated with:

Cold environments (it is psychrotrophic, meaning it can grow at low temperatures)
Raw milk and dairy processing
Soil and water sources
Chicken and other poultry environments where it has been isolated and found to carry antimicrobial-resistance traits

Its environmental adaptability makes it capable of surviving in moist, nutrient-low conditions—such as those found in improperly controlled manufacturing environments or water-based consumer products.

Symptoms of Infection

If an individual were to be exposed to a product contaminated with P. lactis, symptoms could vary depending on the site of exposure. Possible manifestations may include:

Upper respiratory or sinus-related symptoms

Irritation
Worsening congestion
Mild inflammation

In immunocompromised individuals

Because Pseudomonas species as a group can cause opportunistic infections, people with weakened immune systems could theoretically face more significant symptoms, such as:

Exacerbated respiratory issues
Localized infections at the site of exposure
Systemic infection (rare)

Regulatory agencies emphasize that most healthy individuals are unlikely to experience severe symptoms, but affected products should still not be used.

How Are Infections Treated?

Treatment depends on the infection site and severity. In general:

Healthcare evaluation is strongly recommended for anyone who may have been exposed and is experiencing symptoms.
Pseudomonas species can show varying levels of antibiotic resistance.
Clinical management typically involves culture-guided antibiotic therapy.
For mild, localized reactions, supportive care may be sufficient.

How an Autonomous Monitoring System Like KRAKEN™ Could Have Helped

Incidents like this reveal a critical gap in conventional quality control: microbial contamination can occur between scheduled testing cycles, and many manufacturers still rely on periodic sampling instead of continuous monitoring.

A system such as KRAKEN™, which performs autonomous, real-time microbial detection, could have helped in several ways:

1. Early Detection Before Products Leave the Facility

Continuous monitoring of water, rinse solutions, or production lines would allow detection of microbes like P. lactis as soon as they appear, not days or weeks later.

2. Rapid Identification of Waterborne Contaminants

Because P. lactis is commonly found in environmental water sources, real-time surveillance would alert operators immediately if an upstream water line, storage tank, or mixing step became contaminated.

3. Preventing Large-Scale Recalls

By catching contamination early, manufacturers could:

Stop production immediately
Quarantine affected batches
Conduct root-cause analysis before distribution
Prevent tens of thousands of units from reaching consumers

4. Protecting Vulnerable Populations

Continuous biosurveillance reduces the risk of exposure for immunocompromised or medically vulnerable individuals, who are most at risk from opportunistic species.