CLASS I ONGOING Drug recall · Reported 2 Apr 2025 · FDA Enforcement Report
SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System recalled
Ascent Consumer Products is recalling SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 700 mg and, distributed nationwide in the US. The recall was initiated on 28 Jan 2025 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-0299-2025
- FDA event ID
- 96290
- Recalling firm
- Ascent Consumer Products, Melville, NY
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 28 Jan 2025
- FDA classified
- 25 Mar 2025
- Reported
- 2 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Bacterial Contamination
- Drug class
- Nasal Sprays
Timeline
| 28 Jan 2025 | Recall initiated by company | |
| 25 Mar 2025 | Classified by FDA | +56 days |
| 2 Apr 2025 | 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: Bacterial contamination with Staphylococcus aureus
Product as listed by the FDA
SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 Soft tip Squeeze Bottle, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00104 1
Where it was distributed
Nationwide in the US.
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Which lots are affected?
Lot# 024122661Al, Exp Date 12/2027
Where was it sold?
Nationwide in the US.
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 96290| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | SinuCleanse Soft Tip NETI POT Nasal Wash System recalled | Ascent Consumer Products | Other Bacterial Contamination | Nationwide | |
| CLASS I | SinuCleanse Premixed Saline Packets recalled by Ascent Consumer Products | Ascent Consumer Products | Other Bacterial Contamination | Nationwide |
More recalls from Ascent Consumer Products
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | SinuCleanse Premixed Saline Packets recalled by Ascent Consumer Products | Ascent Consumer Products | Other Bacterial Contamination | Nationwide |
| Drug | CLASS I | SinuCleanse Soft Tip NETI POT Nasal Wash System recalled | Ascent Consumer Products | Other Bacterial Contamination | Nationwide |