Herbal Doctor Remedies Recalls Herpes V Balm for Unapproved New Drug Status
Herbal Doctor Remedies is recalling Herpes V Balm because the product is misbranded as an unapproved new drug. The balm was sold online in the US and internationally.
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 identifies the hazard as misbranding as an unapproved new drug without reporting specific injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Herbal Doctor Remedies is recalling Herpes V Balm due to Current Good Manufacturing Practice (CGMP) deviations. The FDA has determined that the products are misbranded as unapproved new drugs.
The recalled product was distributed by Herbal Doctor Remedies in Alhambra, California. It was sold online within the United States and internationally to Australia, Canada, Israel, Italy, Japan, Norway, and the United Kingdom. The recall covers all lots within their expiration dates.
Consumers who have purchased this product should stop using it and contact Herbal Doctor Remedies at 1(800) 600-0808 for further instructions.
The recalled product
- Product
- Herpes V 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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