Sundial King of the Forest Herbal Product Recalled for Misbranding
Sundial Herbal Products is recalling King of the Forest herbal products because they are misbranded and deemed unapproved drugs based on 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, and the source text identifies the hazard as misbranding and unapproved drug status based on labeling claims, which aligns with the rubric for moderate severity involving labeling errors.
Plain-English summary
Sundial Herbal Products is recalling its "King of the Forest" traditional organic herbal products. The products are packaged in clear plastic zip-top bags and were distributed in New York. The recall was required by an Order of Permanent Injunction.
The FDA determined that the products are misbranded and deemed unapproved drugs based on their labeling claims. The product labels list uses for hypertension, asthma, throat, kidney, liver spots, and herpes rashes. The recall covers products manufactured, processed, packed, held, and/or distributed between January 1, 2014, and May 27, 2020.
Consumers who have purchased these products should stop using them and contact Sundial Herbal Products for further information.
The recalled product
- Product
- "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***KING OF THE FOREST***1 oz.***USES: HYPERTENSION, ASTHMA, THROAT, KIDNEY, LIVER SPOTS, HERPES RASHES***"; 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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