Sundial Devil Horsewhip Herbal Product Recalled for Misbranding
Sundial Herbal Products is recalling Devil Horsewhip herbal products under a court order because the items are misbranded and considered unapproved drugs.
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 "Devil Horsewhip" traditional organic herbal products. The recall is being conducted under a permanent injunction order issued by the court.
The FDA has determined that the products are misbranded and are deemed unapproved drugs based on the claims made on their labeling. The product description indicates uses for cough, cold, chest pain, fever, and venereal disease.
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 instructions from the recalling firm or the FDA regarding disposal or return.
The recalled product
- Product
- "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***DEVIL HORSEWHIP***1 oz.***USES: COUGH, COLD, CHEST PAIN,***FEVER, VENEREAL DISEASE***"
- 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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