Sundial Herbal Products Recalls Jamaican Bissy Powder for Unapproved Drug Claims
Sundial Herbal Products is recalling Jamaican Bissy 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 primary hazard is regulatory (misbranding/unapproved drug) rather than a specific physical or chemical contamination with reported injuries.
Plain-English summary
Sundial Herbal Products is recalling Jamaican Bissy Powder under a permanent injunction order. The recall is required because the product is misbranded and deemed an unapproved drug based on the claims made on its labeling.
The product description includes claims that the powder regulates the heart, removes water from around the heart, lessens the desire for drugs, cigarettes, and alcohol, and relieves fatigue, depression, headaches, diarrhea, and dysentery. The label also states it is used as an antibiotic and antidote. These claims cause the product to be considered a drug, which it is not approved to be.
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 NY. Consumers should stop using the product and follow instructions from the recalling firm or the FDA regarding disposal or return.
The recalled product
- Product
- Jamaican Bissy Powder; "***Bissy regulates the heart, removes and prevents water from settling around the heart, lessens the desire for drugs, cigarettes, alcohol by clearing the body and blood of poison viruses & toxins etc. Relieves fatigue gives stamina and endurance enabling…
- Manufacturer
- Sundial Herbal Products
- Category
- Drug — Herbal Supplement
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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