Sundial African Fever Bush Recalled for Misbranding and Unapproved Drug Claims
Sundial Herbal Products is recalling African Fever Bush under a permanent injunction because the product is misbranded and deemed an unapproved drug based on its labeling claims.
What this means for you
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 indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the primary issue is regulatory misbranding and unapproved drug status rather than a specific physical hazard like contamination.
Plain-English summary
Sundial Herbal Products is recalling its product "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***African Fever Bush***1oz***USES: FEVER, WORMS IN CHILDREN". This 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 has determined that the products are misbranded and deemed unapproved drugs based on their labeling claims. The specific claims on the label, which include uses for fever and worms in children, contribute to the product being classified as an unapproved drug.
The recall is limited to New York (NY). Consumers who possess 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***African Fever Bush***1oz***USES: FEVER, WORMS IN CHILDREN
- 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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