Sundial Herbal Products Recalls Talibah's Tooth Powder for Misbranding
Sundial Herbal Products is recalling Talibah's Tooth Powder because the product is misbranded and deemed an unapproved drug based on its labeling claims.
The agency’s classification
FDA (Food): 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, which typically involves a situation that may cause temporary or medically reversible adverse health consequences. The hazard is primarily regulatory (misbranding/unapproved drug) rather than a physical safety defect like choking or fire, fitting the Moderate category for labeling/regulatory issues without reported injuries.
Plain-English summary
Sundial Herbal Products is recalling its product, Talibah's Tooth Powder, under a permanent injunction order. The recall is required because the product is misbranded and is deemed an unapproved drug based on the claims made on its labeling.
The recall covers products manufactured, processed, packed, held, and/or distributed between January 1, 2014, and May 27, 2020. The distribution pattern is listed as New York (NY).
Consumers who have this product should stop using it and follow the instructions provided by the recalling firm or the FDA for disposal or return.
The recalled product
- Product
- "SUNDIAL***Talibah's Tooth Powder***"
- Manufacturer
- Sundial Herbal Products
- Category
- Drug — Dental / Oral Care
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 (5)
- Product manufactured
- processed
- packed
- held
- and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 68 recalled by Sundial Herbal Products under a single FDA (Food) 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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