ManukaGuard Nasal Spray Lawsuit Update: Injuries, Recall Status, and Legal Options

The U.S. Food and Drug Administration (FDA) published the manufacturer’s warning that affected nasal spray could cause adverse health consequences requiring medical or surgical treatment. Immunosuppressed individuals faced potentially life-threatening invasive fungal infections, although no adverse events had been reported when the recall was announced.

The recall involved lot 2010045, distributed through Amazon, retail stores, and distributors nationwide. Consumers who developed documented injuries following exposure may have grounds for a product-liability claim, depending on medical evidence and applicable law.

Quick Facts

• Product: ManukaGuard Medical Grade Manuka Honey AllerCleanse Nasal Spray, 1.3 fl. oz. (40 mL).
• Recall: February 10, 2021, involving lot 2010045 with a best-before date of October 2023.
• Hazard: Yeast contamination that could cause serious fungal infections, particularly in immunosuppressed individuals.
• Reported injuries: No adverse events reported when the manufacturer announced the recall.

Latest News on the ManukaGuard Nasal Spray Recall

November 2026

A November 13, 2026 review of the FDA’s published recall announcement confirms that NDAL MFG Inc. voluntarily recalled one lot of ManukaGuard AllerCleanse Nasal Spray because of yeast contamination. The notice identifies lot 2010045, UPC 858631002128, and a best-before date of October 2023 [1].

The review also examined FDA’s March 28, 2022 warning letter concerning NDAL’s manufacturing practices. The agency documented significant quality-control deficiencies and criticized the company’s investigation into contamination involving the recalled lot [2].

These sources establish the historical recall and FDA’s subsequent regulatory findings. They do not provide a current cumulative injury count, completed product-recovery total, or verified information about individual lawsuits.

The November review is a source verification, not a new recall announcement. Current replacement availability and recall completion were not independently established from the records examined.

March 2022

On March 28, 2022, FDA issued a warning letter following an inspection of NDAL’s Monterey, California, facility conducted September 8–20, 2021. The agency identified significant violations of current good manufacturing practice requirements.

FDA specifically criticized NDAL’s investigation into yeast contamination affecting ManukaGuard AllerCleanse lot 2010045. The agency determined that the investigation lacked adequate scientific justification and did not sufficiently evaluate other possible contamination sources.

The warning letter also identified certain ManukaGuard nasal spray products as unapproved new drugs. These findings concern regulatory compliance and do not independently establish civil liability for individual injuries.

February 2021

On February 10, 2021, NDAL announced the voluntary nationwide recall of ManukaGuard AllerCleanse Nasal Spray. The affected product had been distributed through Amazon.com, retailers, and distributors.

The company warned that yeast contamination could require medical intervention and potentially cause life-threatening infections in immunosuppressed individuals. NDAL stated that it had received no adverse-event reports associated with the recall.

Consumers and retailers were instructed to stop using affected products and follow the manufacturer’s return or replacement procedures.

Event	Month/Year	Type	Status	Source	Notes
FDA recall and warning-letter review	November 2026	Source verification	Reviewed	[1]	Original recall findings verified
FDA manufacturing warning letter	March 2022	Regulatory enforcement	Issued	[2]	Quality-control and investigation deficiencies documented
Nationwide nasal spray recall	February 2021	Product recall	Announced	[1]	One contaminated lot recalled

What Is the ManukaGuard Nasal Spray Recall?

The recall involves ManukaGuard Medical Grade Manuka Honey AllerCleanse Nasal Spray, distributed by NDAL MFG Inc. of Monterey, California. The product was marketed for cleaning nasal passages and sinuses of irritants and environmental contaminants.

Testing identified yeast contamination in one production lot. The company initiated a consumer-level recall and arranged for affected products to be returned or replaced.

Which ManukaGuard Nasal Spray Products Are Recalled?

The affected product was sold in a 40 mL nasal spray bottle packaged in an individual cardboard carton.

Product Identification

• Brand: ManukaGuard
• Product: Medical Grade Manuka Honey AllerCleanse Nasal Spray
• Size: 1.3 fl. oz. (40 mL)
• Lot number: 2010045
• Best-before date: October 2023
• UPC: 858631002128

Consumers should compare the product’s lot number and packaging with the FDA announcement. The recall did not automatically include every ManukaGuard nasal spray product.

What’s the Problem With ManukaGuard Nasal Spray?

The product was found to contain yeast contamination, creating a risk of introducing unwanted microorganisms into nasal passages. Certain fungal organisms can cause infections, particularly when a person’s immune defenses are weakened.

NDAL warned that exposure could result in health consequences requiring medical or surgical treatment. The FDA announcement did not identify the specific yeast species found in the recalled product.

What Health Risks Are Associated With Contaminated Nasal Spray?

Fungal exposure can present health risks depending on the organism, individual medical conditions, and severity of infection. Potential complications include:

• Nasal or sinus irritation
• Persistent sinus inflammation
• Fungal infections affecting nasal tissues
• Infections requiring prescription treatment
• Hospitalization for severe complications
• Invasive fungal infections in immunosuppressed individuals

These are potential complications rather than injuries confirmed among ManukaGuard consumers. Anyone experiencing persistent sinus symptoms, fever, or worsening illness following product use should seek medical evaluation.

Why Are Immunosuppressed Consumers at Greater Risk?

People with weakened immune systems may have greater difficulty controlling certain fungal infections. Individuals receiving immunosuppressive treatments or managing serious underlying conditions may face increased risks.

NDAL specifically warned that contaminated AllerCleanse nasal spray could cause life-threatening invasive fungal infections in immunosuppressed individuals. This warning describes a possible consequence, not a confirmed injury involving the recalled product.

What Did FDA Find During Its NDAL Investigation?

FDA’s March 2022 warning letter documented failures involving quality oversight, manufacturing specifications, and investigation procedures. The agency found that NDAL’s quality-control systems did not adequately ensure that products met applicable standards.

The agency also questioned whether NDAL had thoroughly investigated the source of yeast contamination or adequately evaluated the possibility that other products were affected.

FDA’s regulatory findings may provide relevant evidence when evaluating manufacturing practices. However, the warning letter is not a court judgment determining product-liability damages.

Have Injuries Been Reported From ManukaGuard Nasal Spray?

NDAL reported no adverse events associated with the recall when it announced the action in February 2021. The FDA-posted announcement did not identify confirmed infections, hospitalizations, or deaths caused by the affected lot.

The reviewed FDA records do not establish a later cumulative injury count through November 2026. This limitation should not be interpreted as evidence that no subsequent injuries occurred.

Where Was ManukaGuard Nasal Spray Sold?

The recalled nasal spray was distributed nationwide through Amazon.com, retail stores, and distributors. The manufacturer’s announcement did not identify every retail location.

The recall applied to affected products regardless of purchase location. Consumers investigating past exposure should retain any available purchase documentation.

What Should Consumers Do With Recalled ManukaGuard Nasal Spray?

NDAL instructed consumers to discontinue use and follow return or replacement procedures. The original recall contact information included:

• Company: NDAL MFG Inc.
• Telephone: 800-916-1220
• Email: support@manukaguard.com
• Hours originally listed: Monday–Friday, 7:30 a.m.–4 p.m. Pacific Time

These instructions date to February 2021. Their continued availability has not been independently confirmed, and the affected lot’s best-before date has passed.

Consumers experiencing medical problems potentially associated with past use should contact a healthcare professional.

Could NDAL Be Liable for ManukaGuard Nasal Spray Injuries?

Product-liability law may permit compensation when evidence establishes that a contaminated product caused injury. Depending on applicable state law, potential claims may involve manufacturing defects, negligent quality control, or inadequate warnings.

The FDA recall and warning letter document safety and manufacturing concerns. Neither automatically proves that NDAL caused an individual consumer’s medical condition.

Medical causation, product identification, damages, and filing deadlines are essential considerations.

Who May Be Affected by the ManukaGuard Recall?

Consumers who purchased or used recalled lot 2010045 were potentially exposed to the contamination hazard. Individuals with weakened immune systems may have faced increased risks.

Consumers who developed medically documented infections following use may have additional legal questions. Eligibility for compensation depends on evidence connecting the product to the injury.

Do I Qualify for a ManukaGuard Nasal Spray Lawsuit?

The following questions may help determine whether a potential claim warrants evaluation:

• Did you use ManukaGuard AllerCleanse Nasal Spray from recalled lot 2010045?
• Did you develop a fungal infection or another documented medical condition after using the product?
• Did the illness require medical treatment, hospitalization, or prescription medication?
• Do you have purchase records, product packaging, laboratory results, or other supporting evidence?

Answering yes does not establish eligibility or guarantee compensation. An attorney can assess causation, damages, available evidence, and applicable filing deadlines.

What Evidence Should Injured Consumers Preserve?

Documentation may help establish product exposure and the circumstances of an alleged injury. Relevant evidence includes:

• The nasal spray bottle and packaging
• Photographs of the lot number and expiration date
• Amazon orders or retail purchase records
• Medical records and treatment histories
• Fungal cultures and laboratory results
• Hospital and prescription records
• Communications with NDAL or retailers
• Medical expenses and lost-income documentation

Consumers considering legal action may wish to obtain evidence-preservation guidance before discarding relevant materials. The recalled product should remain out of use.

How Can Consumers Report a Suspected Adverse Reaction?

Consumers and healthcare professionals may report suspected adverse reactions or product-quality concerns through FDA’s MedWatch program.

FDA provides online reporting and instructions for submitting safety reports at [3].

Submitting an adverse-event report does not independently establish that a product caused an illness. Reports can nevertheless help regulators identify potential safety concerns.

What Compensation May Be Available?

Potential damages in qualifying cases may include medical expenses, hospitalization costs, future treatment, lost income, pain and suffering, and other legally recognized losses.

Severe infections may require prolonged treatment or rehabilitation. Compensation amounts vary by case. Past results do not guarantee future outcomes.

Speak With a ManukaGuard Nasal Spray Lawyer

If you developed a serious infection after using recalled ManukaGuard nasal spray, a product-liability attorney can review your medical records, product information, and exposure history. A free case review can help determine whether the evidence and applicable law support a potential injury claim.

How Does a ManukaGuard Nasal Spray Lawsuit Work?

1. Free case review. An attorney evaluates the product, exposure history, injuries, and documentation.
2. Investigation. Evidence may include FDA findings, medical records, laboratory tests, and expert evaluations.
3. Filing. If supported by the evidence and applicable law, a product-liability claim may be filed.
4. Discovery/negotiation. The parties exchange evidence, assess damages, and may discuss settlement.
5. Resolution. A case may conclude through settlement, dismissal, court ruling, or trial.

Frequently Asked Questions

What is the ManukaGuard Nasal Spray Lawsuit?

The ManukaGuard Nasal Spray Lawsuit refers to potential claims involving injuries allegedly associated with recalled AllerCleanse nasal spray. The recall does not independently establish a filed lawsuit or finding of liability.

Why was ManukaGuard nasal spray recalled?

NDAL recalled one lot after yeast contamination was discovered. The manufacturer warned that exposure could cause serious infections, particularly among immunosuppressed individuals.

Which ManukaGuard nasal spray lot was recalled?

The recall covered lot 2010045, with a best-before date of October 2023 and UPC 858631002128. Other ManukaGuard products were not automatically included.

What did FDA find during its investigation?

FDA identified manufacturing-quality violations and deficiencies in NDAL’s contamination investigation. The findings were documented in a March 28, 2022 warning letter.

Have injuries been reported from ManukaGuard nasal spray?

NDAL reported no adverse events when announcing the recall in February 2021. The reviewed sources do not establish a later cumulative injury total.

Can I file a ManukaGuard Nasal Spray Lawsuit?

A consumer with a documented injury may have a potential claim if evidence supports product-related causation and legal liability. Eligibility depends on the circumstances, damages, and filing deadlines.

Is there a ManukaGuard nasal spray settlement?

The cited FDA records address the recall and manufacturing violations rather than litigation outcomes. Determining whether a specific lawsuit or settlement exists requires separate court-record verification.

References

1. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ndal-mfg-inc-issues-voluntary-nationwide-recall-manukaguard-allercleanse-nasal-spray-due
2. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ndal-mfg-inc-621656-03282022
3. https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program