Elevated risk U.S. Food and Drug Administration

SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System recall: Microbial contamination of the product with Staphylococcus aureus (S. aureus)

Recall published 1+ years ago

Microbial contamination of the product with Staphylococcus aureus (S. aureus)

SinuCleanse Prescription & OTC drugs — recalled prescription & otc drugsSinuCleanse Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)SinuCleanse Prescription & OTC drugs — recalled prescription & otc drugs (photo 3)SinuCleanse Prescription & OTC drugs — recalled prescription & otc drugs (photo 4)
4 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Microbial contamination

This recall is a contamination finding. The product may be perfectly normal to look at, because testing — not appearance — is what caught it.

What the notice says: Use of the SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System, contaminated with S. aureus , can result in blood infections in users whose nasal mucosa may be compromised due to inflammation and mechanical injuries, caused by nasal irrigation.

Why it matters: The product was found, or is suspected, to carry a harmful micro-organism. The agency notice names the specific organism and that detail matters, because the illness it causes and the people most at risk differ from one to the next.

Symptoms and when to call a doctor

Most foodborne infections cause stomach cramps, diarrhoea, nausea and sometimes fever, starting anywhere from hours to weeks after exposure depending on the organism. See a doctor for a high fever, bloody diarrhoea, vomiting that stops you keeping liquids down, diarrhoea lasting more than three days, or signs of dehydration. Infants, pregnant people, adults over 65 and anyone immunocompromised should seek advice earlier.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
February 25, 2025
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
SinuCleanse
Product type
Prescription & OTC drugs
Distribution
Nationwide
Reports of harm
To date, no adverse events have been reported to Ascent Consumer Products, Inc. related to this recall.

Products covered by this recall

Soft Tip Squeeze Bottle Nasal Wash System

What the company announced

FOR IMMEDIATE RELEASE: 02/25/2025 Melville, NY. Ascent Consumer Products Inc. is voluntarily recalling one lot of SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System to the consumer level. The recall is being initiated due to a confirmed test result of microbial contamination of the product with Staphylococcus aureus (S. aureus) .

Risk Statement:

Use of the SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System, contaminated with S. aureus , can result in blood infections in users whose nasal mucosa may be compromised due to inflammation and mechanical injuries, caused by nasal irrigation. Resulting secondary infections may occur, such as endocarditis (infection of the heart’s inner lining), bone and joint infections, splenic abscesses or meningitis, and bacterial sinusitis which may lead to eye tissue infections, vision problems, cranial nerve damage, or meningitis. These infections are serious and potentially life-threatening. To date, no adverse events have been reported to Ascent Consumer Products, Inc. related to this recall.

SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System is used as a nasal wash of the nasal passages to help temporarily relieve symptoms associated with sinusitis, cold, flu, or allergies. The only affected product lot includes the following:

  • Product Name: SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System · Lot Number: 024122661A1 · Expiration Date: 12-31-2027

The SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System is packaged in a carton, containing the squeeze bottle and 30 Saline Packets. The lot number and expiration date can be identified on the side of the carton or on the back of the Saline Packets within the carton. The affected lot was distributed in January 2025 nationwide through retail and online outlets.

Ascent Consumer Products Inc. is notifying its distributors and customers by electronic mail. Distributors and retailers in possession of the affected lot should immediately cease distribution and remove the recalled SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System lot from inventory. Consumers who have this product should discontinue use immediately and return it to the place of purchase or discard it.

Consumers with questions regarding this recall can contact Ascent Consumer Products Inc. by email at [email protected] Monday-Friday from 9am-5pm ET. Consumers should contact their physician or healthcare provider if they experience any problems related to the use of this product.

Reporting Adverse Reactions

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program:

Online : www.fda.gov/medwatch/report.htm

Regular Mail or Fax : Download a form at www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 024122661A1

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 12-31-2027

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Contamination

SinuCleanse — This recall is a contamination finding. The product may be perfectly normal to look at, because testing — not appearance — is what caught it.

  1. Stop eating it and keep it separate from other food.
  2. Clean and sanitise the fridge shelf, container or surface it was stored on.
  3. Read the official notice for the organism named — the advice for Listeria, Salmonella and hepatitis A is not the same.
  4. If anyone who ate it is unwell, mention the recall and the date by name when you call a clinician.

Getting a refund without the pack

The commonest reason people skip the refund is that they have already thrown the item away. That rarely matters.

  • A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.
  • Store credit is often offered first. You can ask for the original payment method instead, and it is normally granted.
  • No photo either? Ask anyway. Grocery chains settle recall refunds at the service desk because disputing them costs more than paying them.
  • For a multi-pack or a case, ask for the full purchase price rather than a per-unit figure — the recall covers what you paid.

Remedy named in the notice: Consumers who have this product should discontinue use immediately and return it to the place of purchase or discard it.

Company contact: Ascent Consumer Products Inc. — Consumers: Ascent Consumer Products, Inc., [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was SinuCleanse prescription & otc drugs recalled?

Microbial contamination of the product with Staphylococcus aureus (S. aureus) Use of the SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System, contaminated with S. aureus , can result in blood infections in users whose nasal mucosa may be compromised due to inflammation and mechanical injuries, caused by nasal irrigation.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 024122661A1; best-by date 12-31-2027. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop eating it and keep it separate from other food.

Can I get my money back?

The notice says: Consumers who have this product should discontinue use immediately and return it to the place of purchase or discard it.

Where was the recalled product sold?

It was distributed nationwide.

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