Multiple Nasal Spray Products Subject to Recent Recalls
Staying up-to-date on pharmaceutical product recalls is a crucial aspect of personal health management. In late 2024 and early 2025, several nasal sprays and related nasal hygiene systems were voluntarily recalled by their manufacturers, often in coordination with the U.S. Food and Drug Administration (FDA). The primary reasons for these recalls include potential microbial contamination and manufacturing defects.
Recall of NeilMed NasoGel Spray
In February 2025, NeilMed Pharmaceuticals Inc. initiated a worldwide, voluntary Class II recall for specific lots of its NasoGel Spray due to a "microbial failure" discovered during routine stability testing. The company received consumer reports of an "unpleasant odor" associated with the product. A microbial contamination can lead to serious adverse effects, including respiratory tract infections, particularly in immunocompromised individuals.
Recalled Lots of NeilMed NasoGel Spray:
- Lot NGS751
- Lot NGS757
- Lot NGS762
These lots were distributed starting in 2024. The recall affected pharmacies and stores nationwide, including Walgreens, Rite Aid, and Walmart. Consumers in possession of these lot numbers should immediately stop use and follow NeilMed's instructions for disposal and refund.
Recall of Ascent's SinuCleanse Nasal Wash System
Also in February 2025, Ascent Consumer Products Inc. announced a voluntary recall of one lot of its SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System. The recall was prompted by a confirmed test result showing microbial contamination with Staphylococcus aureus (S. aureus). An infection from S. aureus can be serious and potentially life-threatening, especially for at-risk individuals. While no adverse events were reported at the time of the recall, the potential risk warranted the product's removal from the market.
Recall of Ryaltris Nasal Spray
In September 2024, Glenmark Pharmaceuticals Inc., USA, recalled several lots of its Ryaltris nasal spray, a prescription medication for seasonal allergic rhinitis. The reason for this Class II recall was a defective delivery system where the dip tube was clogged, preventing the spray from functioning properly. While this poses a less immediate health threat than contamination, it prevents patients from receiving their prescribed medication effectively.
FDA Warns Against Using SnoreStop Nasal Spray
In September 2024, the FDA issued a warning for consumers to stop using SnoreStop Nasal Spray by Green Pharmaceuticals due to potential microbial contamination and concerns about poor manufacturing controls. This was not the first time the company had issues; the FDA had previously issued a warning letter and a recall for a different SnoreStop product in 2022 for similar reasons. The FDA's warning applies to all SnoreStop Nasal Spray products from this manufacturer.
Comparison of Recent Nasal Spray Recalls
Product Name | Manufacturer | Recall Date | Reason for Recall | FDA Class | Potential Health Risk |
---|---|---|---|---|---|
NasoGel Spray | NeilMed Pharmaceuticals Inc. | Feb 2025 | Microbial Failure | Class II | Respiratory infections, flu-like symptoms |
SinuCleanse Nasal Wash System | Ascent Consumer Products Inc. | Feb 2025 | Staphylococcus aureus contamination | Class II | Serious, potentially life-threatening infections |
Ryaltris Nasal Spray | Glenmark Pharmaceuticals Inc., USA | Sept 2024 | Defective Delivery System | Class II | Ineffective treatment; reversible health consequences |
SnoreStop Nasal Spray | Green Pharmaceuticals Inc. | Sept 2024 | Microbial Contamination | Warning Issued | Potential for infections |
What to Do If You Have a Recalled Nasal Spray
- Check your product: Locate the brand name and lot number on the packaging or bottle. Compare it against the information provided in the recall notices.
- Stop use immediately: If your product matches the recall information, do not use it under any circumstances, even if you feel no adverse effects.
- Properly dispose of the product: Follow the manufacturer's specific instructions for disposal. In some cases, proof of destruction (e.g., a photo) may be required for a refund.
- Contact the manufacturer: Get in touch with the company for instructions on how to receive a refund or replacement. NeilMed, for example, has provided a dedicated email address for affected customers.
- Report adverse reactions: If you used a recalled product and have experienced any unusual symptoms or health issues, report them to your healthcare provider and the FDA's MedWatch program.
Conclusion
The recent spate of nasal spray recalls, including prominent cases involving NeilMed NasoGel and Ascent's SinuCleanse, underscores the importance of a vigilant approach to consumer medication safety. These alerts, triggered by microbial contamination and manufacturing defects, serve as a critical reminder for consumers to routinely check for recall information and act swiftly if they possess an affected product. By taking these precautions and staying informed through official sources like the FDA, consumers can minimize their health risks and ensure the safety of the products they use. For comprehensive information on current and past medication recalls, the FDA's website is the definitive resource for consumers and healthcare professionals alike.
Visit the FDA's website for drug safety information
Key Safety Measures for Nasal Spray Users
- Check Lot Numbers: Always confirm your product's lot number against FDA and manufacturer recall announcements.
- Monitor for Defects: For non-contamination recalls like Ryaltris, check for physical defects such as clogged nozzles before use.
- Trust Your Senses: Pay attention to unusual smells, discoloration, or changes in the product's appearance or consistency.
- Report Concerns: If you suspect a problem with a product, report it to the FDA's MedWatch program to help identify potential issues.
- Dispose of Contaminated Items: Follow manufacturer-provided instructions for disposing of recalled products to prevent any harm.