Ascent Consumer Products Inc. drug recall: SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Drugs
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 96290
- Recall initiated
- Jan 28, 2025
- Classified by FDA
- Mar 25, 2025
- Posted in Enforcement Report
- Apr 2, 2025
- Recalling firm
- Ascent Consumer Products Inc.
- Firm location
- Melville, NY, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Products in this event
- 3
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Jan 28, 2025. FDA classified it 56 days later, on Mar 25, 2025. This recall event covers 3 separate products, each with its own FDA recall number. Distribution reported by FDA: Nationwide in the US.
Recalled products (3)
D-0299-2025 Class I Ongoing
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
Codes / lots: Lot# 024122661Al, Exp Date 12/2027
Quantity: 4,176 cartons
D-0300-2025 Class I Ongoing
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
Codes / lots: Lot# 024122661Al, Exp Date 12/2027
Quantity: unknown
D-0301-2025 Class I Ongoing
SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 kettle style Neti Pot, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00102 7
Codes / lots: Lot# 024122661Al, Exp Date 12/2027
Quantity: unknown
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA drug enforcement dataset
- Official notice
- FDA Enforcement Report, event 96290
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.