Sundial Bitter Wood Herbal Product Recalled for Unapproved Drug Claims
Sundial Herbal Products is recalling Bitter Wood herbal products under a court order because the labels make unapproved drug claims.
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 and involves misbranding and unapproved drug claims without reported illnesses or injuries, fitting the criteria for moderate severity.
Plain-English summary
Sundial Herbal Products is recalling its Bitter Wood traditional organic herbs product, a 2-ounce herbal preparation. The recall is required by an Order of Permanent Injunction.
The FDA determined that the products are misbranded and deemed unapproved drugs based on the labeling claims. The product labels state that the herbs expel worms, destroy parasites, treat leukemia, and destroy the appetite for alcohol.
The affected products were manufactured, processed, packed, held, and/or distributed between January 1, 2014, and May 27, 2020. The recall is limited to New York. Consumers should stop using the product and follow the instructions provided by the recalling firm.
The recalled product
- Product
- "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BITTER WOOD***2 oz.***USES: EXPELS WORMS IN THE WEST INTESTINES, DESTROYS PARASITES, LEUKEMIA, DESTROY APPETITE FOR ALCOHOL***"
- Manufacturer
- Sundial Herbal Products
- Category
- Drug — Herbal Supplements
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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