The Recall Desk
ModerateFDA (Drugs)·D-1165-2020·Announced 2020-04-15

Herbal Doctor Remedies Recalls Sweat Oil for Unapproved New Drug Status

Herbal Doctor Remedies is recalling Sweat Oil 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 involves a temporary or medically reversible adverse health consequence. The specific hazard is misbranding as an unapproved new drug, which fits the Moderate severity criteria for labeling/regulatory issues without reported injuries.

Plain-English summary

Herbal Doctor Remedies is voluntarily recalling Sweat Oil. The FDA has determined that the product is misbranded as an unapproved new drug, which constitutes a Current Good Manufacturing Practice (CGMP) deviation.

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 the expiry date are affected.

Consumers who have purchased Sweat Oil should stop using the product and contact Herbal Doctor Remedies at 1(800) 600-0808 for further instructions.

The recalled product

Product
Sweat Oil, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808

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.

See all 70 products in this recall →