The Recall Desk
CriticalFDA (Drugs)·D-0269-2021·Announced 2021-03-03

NDAL Recalls ManukaGuard Nasal Spray Due to Yeast Contamination

NDAL Mfg Inc. is recalling ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal Spray because the product was confirmed to contain yeast.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source text explicitly identifies this as an FDA Class I recall, which mandates a severity score of 5 according to the rubric.

Plain-English summary

NDAL Mfg Inc. is recalling ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal Spray, 1.3 FL OZ (40mL) bottles. The recall involves 4,265 bottles with Lot # 2010045 and a Best Before date of 10 2023. The product was distributed nationwide in the USA and in Hong Kong.

The recall was initiated because the product was confirmed to have yeast contamination. This is a Class I recall issued by the U.S. Food and Drug Administration.

Consumers should stop using the product and return it to the place of purchase or contact the recalling firm for instructions.

The recalled product

Product
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 002
Manufacturer
NDAL Mfg Inc.
Category
Drug — Nasal Spray
Hazard
Affected units
4,265

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • LOT # 2010045
  • Best Before 10 2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · microbial contamination

See all →