Restore Sinus Spray Recalled for Microbial Contamination
Biomic Sciences is recalling Restore Sinus Spray due to microbial contamination of the non-sterile product. The product is distributed nationwide and internationally.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a non-sterile product delivered intranasally to sensitive mucous membranes, constituting a risk-of-harm situation per the severity rubric. No illnesses or injuries have been reported, and the hazard remains precautionary. The FDA Class II classification and the direct intranasal application route support a High severity assignment.
Plain-English summary
Biomic Sciences, LLC, dba ION Intelligence of Nature, is recalling all lots of Restore Sinus Spray due to microbial contamination. The product is a sinus spray distributed nationwide in the United States and internationally in Canada, New Zealand, Australia, Indonesia, Malaysia, Great Britain, and the Netherlands.
The recall affects all lots currently within expiration. Consumers who have purchased this product should stop using it. For instructions on return or disposal, consumers should contact the manufacturer. For official FDA documentation, refer to the FDA's Drug Recalls page.
The recalled product
- Product
- Restore Sinus Spray, Manufactured by: Biomic Sciences, LLC Charlottesville, VA
- Category
- Drug — Nasal / Sinus
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Biomic Sciences, LLC dba ION Intelligence of Nature under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Biomic Sciences, LLC dba ION Intelligence of Nature
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