Purple Gold Balm Recalled for Misbranding as Unapproved New Drug
Herbal Doctor Remedies is recalling Purple Gold Balm because it is misbranded as an unapproved new drug. The product was sold online in the US 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 indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The specific hazard is misbranding as an unapproved new drug, which fits the criteria for a moderate severity recall involving regulatory violations without reported serious injury.
Plain-English summary
Herbal Doctor Remedies is recalling Purple Gold Balm due to Current Good Manufacturing Practice (CGMP) deviations. The FDA has determined that the product is misbranded as an unapproved new drug.
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. All lots within expiry are affected.
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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