Sundial Herbal Products Recalls Palo De Brazil Wood Under FDA Injunction
Sundial Herbal Products is recalling Palo De Brazil Wood in New York because the product is misbranded and deemed an unapproved drug.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls are scored as 4 (Severe).
Plain-English summary
Sundial Herbal Products is recalling Palo De Brazil Wood in New York. The recall is required by an Order of Permanent Injunction. The product was manufactured, processed, packed, held, and/or distributed between January 1, 2014, and May 27, 2020.
The FDA determined that the products are misbranded and deemed unapproved drugs based on labeling claims. The product description includes claims that the wood is "great to reduce the sugar in the blood and removes gall stone from the kidneys" and provides instructions to put the wood in pure water and drink it.
Consumers who purchased this product should stop using it and contact Sundial Herbal Products for further instructions.
The recalled product
- Product
- "***PALO DE BRAZIL***BRASIL WOOD***great to reduce the sugar in the blood and removes gall stone from the kidneys***INSTRUCTIONS. put the wood in pure water and keep in the refrigerator then drink when thirsty***"
- Manufacturer
- Sundial Herbal Products
- Category
- Drug — Unapproved 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 (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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