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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Over-the-Counter

SinuCleanse Nasal Wash Products Recalled for Staphylococcus aureus Contamination

Agency Publication Date: March 25, 2025
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Summary

Ascent Consumer Products Inc. has recalled approximately 4,176 cartons of SinuCleanse Nasal Wash Systems and Saline Packets because they may be contaminated with Staphylococcus aureus bacteria. The recall includes Soft Tip Squeeze Bottle kits, Neti Pot kits, and standalone 60-count saline packets. These non-sterile nasal wash products are used to treat congestion and allergies; using contaminated saline solution can lead to serious respiratory or sinus infections.

Risk

Bacterial contamination with Staphylococcus aureus poses a significant health risk, particularly for individuals with weakened immune systems. Using these products for nasal irrigation can introduce the bacteria directly into the nasal passages, potentially causing severe infections.

What You Should Do

  1. This recall affects SinuCleanse Soft Tip Squeeze Bottle Nasal Wash Systems (UPC 646011001041), Soft Tip Neti Pot Nasal Wash Systems (UPC 646011001027), and 60-count Premixed Saline Packets (UPC 646011001034).
  2. Check the side of the carton or the back of individual salt packets for lot number 024122661Al and an expiration date of 12/2027.
  3. If you have health concerns after using these products, contact your healthcare provider or pharmacist immediately.
  4. Return any unused product to the place of purchase for a refund, throw it away, or contact Ascent Consumer Products Inc. at 1-888-547-5492 for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information regarding this recall.

Your Remedy Options

You have 2 options:

💰Option 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
🗑️Option 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (30-count)
Variants: 30-count All Natural USP Grade Saline Packets, 1 Soft tip Squeeze Bottle
UPC Codes:
646011001041
Lot Numbers:
024122661Al (Exp 12/2027)

Net WT 0.1 OZ (3g) each packet

Product: SinuCleanse Premixed Saline Packets (60-count)
Variants: 60-count All Natural USP Grade Saline Packets
UPC Codes:
646011001034
Lot Numbers:
024122661Al (Exp 12/2027)

Net WT 0.1 OZ (3g) each packet

Product: SinuCleanse Soft Tip Neti Pot Nasal Wash System (30-count)
Variants: 30-count All Natural USP Grade Saline Packets, 1 kettle style Neti Pot
UPC Codes:
646011001027
Lot Numbers:
024122661Al (Exp 12/2027)

Net WT 0.1 OZ (3g) each packet

Product Images

SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System, 30 saline packets

SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System, 30 saline packets

SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System, Lot Number 024122661A1; Expiration Date 12-31-2027

SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System, Lot Number 024122661A1; Expiration Date 12-31-2027

SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System, Side view

SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System, Side view

SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System, saline packet front view

SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System, saline packet front view

SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System, back view with lot number and expiration date

SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System, back view with lot number and expiration date

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96290
Status: Active
Manufacturer: Ascent Consumer Products Inc.
Sold By: Authorized retailers; Drug stores; Grocery stores
Manufactured In: United States
Units Affected: 3 products (4,176 cartons; unknown; unknown)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.