FDA Recalls Sundial Herbal Bitter Kola for Unapproved Drug Claims
Sundial Herbal Products is recalling Bitter Kola (Arogbo) in New York 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 involves a temporary or medically reversible adverse health consequence. The source text identifies the hazard as misbranding and unapproved drug status based on labeling claims, without reporting specific illnesses or injuries, fitting the Moderate severity criteria for labeling and regulatory violations.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Bitter Kola (Arogbo) manufactured by Sundial Herbal Products. The recall is required by an Order of Permanent Injunction. The product was distributed in New York (NY).
The FDA determined that the products are misbranded and deemed unapproved drugs based on their labeling claims. The product description includes claims that it acts as a natural antibiotic, kills bacteria and viruses, prevents infections, serves as an antidote to poisons, and treats conditions such as Ebola, colitis, diarrhea, dysentery, and HIV/AIDS.
Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions. The recall covers products manufactured, processed, packed, held, and/or distributed between January 1, 2014, and May 27, 2020.
The recalled product
- Product
- Bitter Kola (Arogbo); "***a Natural Antibiotic kills all bacteria, virus, Infections and prevent them***it's a good antidote to all poisons, it's used against stomach problem like EBOLA, Colitis, Diarrhea; dysentery etc. It suppresses the Bacteria that causes them***strengthen im
- 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.
See all 68 products in this recall →Related recalls
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