CLASS I Drug recall · Reported 1 Nov 2023 · FDA Enforcement Report
ION*Sinus Spray recalled by Biomic Sciences
Biomic Sciences is recalling ION*Sinus Spray, distributed nationwide in the US. The recall was initiated on 29 Sep 2023 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0067-2024
- FDA event ID
- 93150
- Recalling firm
- Biomic Sciences, Charlottesville, VA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 29 Sep 2023
- FDA classified
- 24 Oct 2023
- Reported
- 1 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
Timeline
| 29 Sep 2023 | Recall initiated by company | |
| 24 Oct 2023 | Classified by FDA | +25 days |
| 1 Nov 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial contamination of Non-Sterile Products
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA
Where it was distributed
Nationwide in the United States and to Canada, New Zealand, Australia, Indonesia, Malaysia, Great Britain, and the Netherlands
Questions about this recall
Why was it recalled?
Microbial contamination of Non-Sterile Products
Which lots are affected?
All lots within expiry.
Where was it sold?
Nationwide in the United States and to Canada, New Zealand, Australia, Indonesia, Malaysia, Great Britain, and the Netherlands
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 93150| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Restore Sinus Spray recalled by Biomic Sciences | Biomic Sciences | Sterility | Nationwide | |
| CLASS II | ION* Sinus Support Nasal Spray recalled by Biomic Sciences | Biomic Sciences | Sterility | Nationwide |
More recalls from Biomic Sciences
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | ION* Sinus Support Nasal Spray recalled by Biomic Sciences | Biomic Sciences | Sterility | Nationwide |
| Drug | CLASS II | Restore Sinus Spray recalled by Biomic Sciences | Biomic Sciences | Sterility | Nationwide |