The Recall Desk
HighFDA (Drugs)·D-0069-2024·Announced 2023-11-01

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.

What this means for you

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
Manufacturer
Biomic Sciences, LLC dba ION Intelligence of Nature
Category
Drug — Nasal / Sinus
Hazard
  • microbial-contamination

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.

Related recalls

Same category