CLASS I ONGOING Drug recall · Reported 3 Mar 2021 · FDA Enforcement Report
ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal recalled
Ndal Mfg is recalling ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal Spray, 270 measured sprays, distributed nationwide in the US. The recall was initiated on 17 Dec 2020 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0269-2021
- FDA event ID
- 87101
- Recalling firm
- Ndal Mfg, Monterey, CA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 17 Dec 2020
- FDA classified
- 19 Feb 2021
- Reported
- 3 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Mold
- Drug class
- Nasal Sprays
Timeline
| 17 Dec 2020 | Recall initiated by company | |
| 19 Feb 2021 | Classified by FDA | +64 days |
| 3 Mar 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of Non-Sterile Products: Product confirmed to have yeast
Product as listed by the FDA
ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal Spray, 1.3 FL OZ (40mL) bottle, 270 measured sprays, Distributed by Ndal Laboratories, 449 Alvarado St., Monterey, CA 93940 (bottle); NDAL MFG Inc., 80 Garden Court, Suite 100, Monterey, CA 93940 (carton); UPC 8 58631 00212 8. the Alvarado St. is for the bottle by putting "(bottle); NDAL MFG Inc., 80 Garden Court, Suite 100, Monterey, CA 93940 (carton); UPC 8 58631 00212 8." (according to the label)
Where it was distributed
Distributed Nationwide in the USA and Hong Kong
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-Sterile Products: Product confirmed to have yeast
Which lots are affected?
LOT # 2010045; Best Before 10 2023
Where was it sold?
Distributed Nationwide in the USA and Hong Kong
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.