SnoreStop Nasal Spray Warning Issued By FDA Over Potential Contamination Risks

Manufacturer halted SnoreStop spray sales on its website after an FDA inspection revealed quality control issues and a risk that the spray may be contaminated with microbial bacteria.

Federal drug regulators are urging consumers not to use SnoreStop nasal spray, noting that the manufacturer has twice refused requests to issue a recall, even though there is evidence that the products may be contaminated with  bacteria.

The U.S. Food and Drug Administration (FDA) issued a SnoreStop Nasal Spray safety alert on September 18, warning consumers to immediately stop using the sleep aid, due to potential risks for consumers.

SnoreStop Nasal Spray is a homeopathic product manufactured by Green Pharmaceuticals in Camarillo, California, which is marketed to open the air passages in the nose and reduce congestion, helping a person stop snoring during sleep. The product is marketed for children starting at age five through adults.

SnoreStop Microbial Contamination Detected

During a facility inspection in April 2024, FDA officials uncovered laboratory test results that showed a significant level of microbial contamination in one lot of SnoreStop nasal spray. Additionally, the FDA discovered Green Pharmaceuticals repackaged and distributed items from the contaminated lot for use as single units or in kits.

Microbial contamination in a product that is inhaled can lead to serious infections, the FDA warns. Consumers exposed to the contaminants may suffer life-threatening adverse health effects, especially those with compromised immune systems.

The FDA indicates it has called on Green Pharmaceuticals repeatedly to issue a SnoreStop recall, including as recently as August 13 and September 12. However, the agency claims the company has refused to do so.

Following the FDA inspection on August 8, Green Pharmaceuticals finally destroyed the remaining nasal sprays from the contaminated lot. The company stopped selling nasal spray products on its website, but consumers may have already purchased contaminated products, which is one reason the FDA still wants the company to issue a SnoreStop spray recall.

The FDA has issued warning notices to Green Pharmaceuticals in the past over the company’s lack of sufficient quality controls, including with SnoreStop.

In June 2022, the company issued a voluntary recall because one lot of SnoreStop NasoSpray tested positive for bacterial contamination. The bacteria were identified as Providencia rettgeri, a contaminant that can cause pneumonia and bloodstream infections.

The affected SnoreStop Nasal Spray was sold on the company’s website and other sites. People who have used the product can contact their doctor with any questions or concerns.

The FDA encourages consumers and doctors to report any side effects or symptoms from using SnoreStop Nasal Spray to the FDA’s MedWatch Adverse Event Reporting program.