Class I · High risk
SinuCleanse Soft Tip NETI POT Nasal Wash System
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
SinuCleanse Premixed SALINE PACKETS
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
What was recalled
SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg) for Nasal Wash System, 60-count All Natural USP Grade Saline Packets, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00103 4
- Recalling firm
- Ascent Consumer Products Inc.
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0300-2025 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
Other recalls by Ascent Consumer Products Inc.
All 2025 recalls
Class I · High risk
SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Other microbial contamination recalls from 2025
All microbial contamination recalls
Class I · High risk
ClearLife Allergy Nasal Spray
Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Class I · High risk
ReBoost Nasal Spray
Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Class II · Moderate risk
Walgreens Saline Nasal Spray WITH XYLITOL
Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis
Class I · High risk
Famotidine Injection
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
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