FDA Drugs recall ·
SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0299-2025
- Date
- (initiated January 28, 2025)
- Company / brand
- Ascent Consumer Products Inc.
105 Baylis Rd, Melville, NY, United States - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 4,176 cartons
- Hazard tags
- Sterility Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot# 024122661Al, Exp Date 12/2027
Distribution
Nationwide in the US.
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0299-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.