About the Recalled Product
The recall covers ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal Spray, 1.3 fl. oz. (40 mL) bottles containing approximately 270 measured sprays, with Lot No. 2010045, best-by date 10/2023, and UPC 8 58631 00212 8. The product was distributed nationwide across the United States and in Hong Kong through Amazon.com, retail stores, and distributors.
Latest Updates
The FDA assigned Class I Recall No. D-0269-2021 to ManukaGuard Allercleanse Nasal Spray on March 3, 2021, covering 4,265 bottles of the contaminated lot and noting that use in immunocompromised individuals could cause life-threatening invasive fungal infections while use in the general population may require medical or surgical intervention [1][2]. In March 2022, the FDA issued a warning letter to NDAL MFG finding that the company had no functioning quality control unit, conducted an inadequate contamination investigation, could not confirm whether other products from the same contract manufacturer were also contaminated, and was marketing several ManukaGuard products as drugs without FDA approval — ultimately requiring the company to suspend U.S. drug production [3].
The Contamination and Why It Matters
Laboratory testing confirmed yeast contamination in ManukaGuard Allercleanse Nasal Spray Lot No. 2010045 at levels that triggered a Class I recall. Yeast contamination in a nasal spray is particularly dangerous because the product is administered directly onto the nasal mucosa — a highly vascularized surface with direct access to the sinuses, throat, and lungs — where a contaminating fungal organism has an immediate pathway to cause local infection and, in immunocompromised individuals, systemic fungal disease.
Invasive fungal infections in immunocompromised patients — including transplant recipients, chemotherapy patients, individuals with HIV/AIDS, and long-term steroid users — carry high mortality rates and are frequently resistant to standard antifungal therapy. The FDA’s Class I designation reflects its determination that exposure to this contaminated product created a genuine probability, not merely a remote risk, of this outcome in vulnerable users.
The FDA Warning Letter: Deeper Failures at NDAL MFG
When the FDA inspected NDAL MFG’s Monterey facility in September 2021, it found systemic manufacturing control failures that went far beyond the single contaminated lot. The FDA found that NDAL MFG had no quality control unit — it lacked written procedures for approving incoming components, investigating out-of-specification results, and evaluating consumer complaints, and it could not produce the specifications its contract manufacturers used to release product.
The FDA also found that NDAL MFG’s investigation into the Lot 2010045 contamination was inadequate: the company’s claimed root cause lacked scientific support, the investigation failed to evaluate whether other products from the same contract manufacturer had been affected, and no review of similar complaints was conducted. The agency further found that NDAL MFG had no adequate stability data to support the three-year expiration dates on its products — meaning the shelf-life claims on the label were not scientifically validated.
Unapproved Drugs on the Market
The March 2022 FDA warning letter also found that three ManukaGuard products — the Allercleanse Nasal Spray, Sinus Cleanser, and Extra Strength Nasal Spray — were being marketed as drugs for nasal passage clearance and immune support without FDA approval, in violation of the Federal Food, Drug, and Cosmetic Act. No approved new drug application was in effect for any of them.
Marketing a drug product without FDA approval means the product was never reviewed for safety, effectiveness, or manufacturing quality by the agency — and that NDAL MFG bore sole responsibility for ensuring each batch was safe and uncontaminated, with no independent federal oversight of its manufacturing processes before products reached consumers.
Can I File a Lawsuit?
If you experienced a sinus infection, fungal infection, respiratory infection, or other serious adverse health event after using ManukaGuard Allercleanse Nasal Spray or a related ManukaGuard nasal product, you may have a product liability claim against NDAL MFG for distributing a contaminated, inadequately tested drug product. Contact a product liability attorney as soon as possible, as state filing deadlines apply.
What to Do If You Have This Product
Stop using all ManukaGuard Allercleanse Nasal Spray immediately, particularly any bottles with Lot No. 2010045 and best-by date 10/2023. Return the product to your place of purchase for a refund, or contact NDAL MFG at SUPPORT@MANUKAGUARD.COM or 1-800-916-1220, Monday through Friday, 7:30 a.m. to 4 p.m. PST. Report any adverse reactions to the FDA at 1-800-FDA-1088 or online at fda.gov/medwatch.
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.regdatalab.com/recall/D-0269-2021
3. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ndal-mfg-inc-621656-03282022