Herbal Doctor Remedies Recalls Tution 130 Due to Unapproved New Drug Status
Herbal Doctor Remedies is recalling Tution 130 because the product is misbranded as an unapproved new drug.
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 the product may cause temporary or medically reversible health consequences. The specific hazard is misbranding as an unapproved new drug, which fits the criteria for a moderate severity recall involving regulatory compliance and potential health risks without reported serious injury.
Plain-English summary
Herbal Doctor Remedies is recalling Tution 130. The product is distributed by Herbal Doctor Remedies in Alhambra, California, and is sold online within the United States and internationally to Australia, Canada, Israel, Italy, Japan, Norway, and the United Kingdom.
The recall was initiated because the product has been found to be misbranded as an unapproved new drug. This constitutes a Current Good Manufacturing Practice (CGMP) deviation. The recall applies to all lots within their expiration dates.
Consumers who have purchased Tution 130 should stop using the product. They can contact Herbal Doctor Remedies at 1(800) 600-0808 for further information or to arrange a return.
The recalled product
- Product
- Tution 130, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
- Manufacturer
- Herbal Doctor Remedies
- Category
- Drug — Unapproved New Drug
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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