Sundial Quassia Wood Recalled for Unapproved Drug Claims
Sundial Herbal Products is recalling Quassia Wood under a court order because the product is misbranded and considered an unapproved drug due to its labeling.
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 temporary or medically reversible adverse health consequence. The hazard is primarily regulatory (misbranding/unapproved drug) rather than a direct physical injury risk like choking or fire, fitting the Moderate category for labeling and regulatory compliance issues.
Plain-English summary
Sundial Herbal Products is recalling its Quassia Wood product, which is packaged in clear plastic zip-top bags. The recall is being conducted under a permanent injunction order issued by the court.
The FDA determined that the products are misbranded and are deemed unapproved drugs based on the claims made on the labeling. The product was manufactured, processed, packed, held, and/or distributed between January 1, 2014, and May 27, 2020.
The recall is limited to New York. Consumers who have this product should stop using it and follow the instructions provided by the recalling firm or the FDA regarding disposal or return.
The recalled product
- Product
- "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***QUASSIA WOOD***2 oz.***USES: ALCOHOLISM, LIVER, STOMACH COMPLAINTS, DIGESTIVE SYSTEM, KILLS LICE & PARASITES***"; packaged in clear plastic zip-top bags
- Manufacturer
- Sundial Herbal Products
- Category
- Food — 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.
See all 68 products in this recall →Related recalls
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