Product Safety Update
Product Safety Update: Former SnoreStop® Nasal Spray
In June 2024, Green Pharmaceuticals Inc. initiated a voluntary nationwide recall of a single lot of SnoreStop® Nasal Spray after FDA testing identified potential microbial contamination.
We acted immediately, in cooperation with the U.S. Food & Drug Administration (FDA), and discontinued the nasal spray product.
A 30-Year Safety Record
SnoreStop® has been in business since 1995. In nearly three decades of operation and regular FDA inspections, this was the only incident of its kind in our company's history.
Our long-standing commitment to compliance, safety, and quality remains unchanged.
What Happened
Out of an abundance of caution:
- We immediately recalled the identified lot.
- We launched a comprehensive internal investigation.
- We tested retained samples of the affected lot.
- We tested all other lots currently in distribution.
- All additional testing returned clean results.
Despite those findings, we maintained the recall because consumer safety comes first. We do not take risks when it comes to the health of our customers.
Importantly:
There were no customer complaints related to this lot.
There were no adverse events reported for this lot or any other lot on the market.
What We Did Next
Following this event, we made the decision to strengthen our quality controls even further.
We transitioned the entire production process to an FDA-registered, GMP-certified laboratory facility to ensure the highest manufacturing standards moving forward.
While the nasal spray product has been permanently discontinued, our current SnoreStop® oral sprays and chewable tablets continue to be manufactured under strict quality controls and were not affected by this recall.
Why the FDA Notice Still Appears Online
FDA recall notices remain archived permanently as part of public transparency and regulatory recordkeeping. Although the product is no longer sold, the notice remains accessible through search engines.
We believe transparency is essential, and we stand by the proactive steps we took.
Our Commitment
When an issue was identified:
- We acted voluntarily and immediately
- We cooperated fully with the FDA
- We tested extensively
- We discontinued the product
- We strengthened our manufacturing standards
For nearly 30 years, SnoreStop® has served families seeking natural solutions for non-apneic snoring. That mission continues with the same focus on safety and integrity that has defined our company since day one.