Sundial Herbal Products Recalls Mojo Bush Under FDA Injunction
Sundial Herbal Products is recalling Mojo Bush herbal products under a permanent injunction because the items are misbranded and deemed unapproved drugs.
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 involves misbranding and unapproved drug status without reported illnesses or injuries, fitting the criteria for moderate severity.
Plain-English summary
Sundial Herbal Products is recalling its "MOJO BUSH" traditional organic herbal products, packaged in clear plastic zip-top bags, under a permanent injunction issued by the U.S. Food and Drug Administration. The recall covers products 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 their labeling claims. The source text indicates the products were distributed in New York (NY).
Consumers who purchased these products should stop using them and contact Sundial Herbal Products for further instructions. The recall is mandated by the FDA due to the legal status of the products as unapproved drugs.
The recalled product
- Product
- "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***MOJO BUSH***1 oz.***USES: SKIN, BLOOD PURIFIER, STOMACH & INTESTINAL CLEANSER, REMOVES PARASITES***"; packaged in clear plastic zip-top bags
- 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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