Fungo Balm Recalled for Being an Unapproved New Drug
Herbal Doctor Remedies is recalling Fungo Balm because the product is misbranded as an unapproved new drug.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text cites misbranding as an unapproved new drug without reporting specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity recall.
Plain-English summary
Herbal Doctor Remedies is recalling Fungo Balm, a product distributed from Alhambra, California. The recall was initiated because the product was found to be misbranded as an unapproved new drug, which constitutes a Current Good Manufacturing Practice (CGMP) deviation.
The affected products are sold online within the United States and internationally to Australia, Canada, Israel, Italy, Japan, Norway, and the United Kingdom. All lots within their expiry dates are included in this recall.
Consumers who have purchased Fungo Balm should stop using the product and contact Herbal Doctor Remedies at 1(800) 600-0808 for further instructions.
The recalled product
- Product
- Fungo Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
- Manufacturer
- Herbal Doctor Remedies
- Category
- Drug — Topical OTC
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 (1)
- All lots within expiry
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 70 recalled by Herbal Doctor Remedies under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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