FDA Recalls Purple Gold Balm for Unapproved New Drug Status
Herbal Doctor Remedies is recalling Purple Gold Balm because the product is misbranded as an unapproved new drug. The balm was sold online in the U.S. and internationally.
What this means for you
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, which typically involves a situation that may cause temporary or medically reversible adverse health consequences. The source text identifies the hazard as misbranding as an unapproved new drug without reporting specific injuries or illnesses, aligning with the Moderate severity criteria for labeling and regulatory compliance issues.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Purple Gold Balm, distributed by Herbal Doctor Remedies. The recall is due to Current Good Manufacturing Practice (CGMP) deviations, specifically that the products have been found to be misbranded as unapproved new drugs.
The affected products are all lots within their expiry dates. Distribution occurred online within the United States and internationally to Australia, Canada, Israel, Italy, Japan, Norway, and the United Kingdom.
Consumers who have purchased Purple Gold Balm should stop using the product and contact Herbal Doctor Remedies at 1(800) 600-0808 for further instructions.
The recalled product
- Product
- Purple Gold Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
- Manufacturer
- Herbal Doctor Remedies
- Category
- Drug — Topical Balm
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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