Sundial Herbal Products Recalls Koromantee Colonic Cleaner as Unapproved Drug
Sundial Herbal Products is recalling Koromantee Colonic & Intestinal Cleaner because the product is misbranded and deemed an unapproved drug based on its 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 involves misbranding and unapproved drug status based on labeling claims, which aligns with the rubric for minor labeling errors or low-risk issues without reported injuries.
Plain-English summary
Sundial Herbal Products is recalling 16-ounce glass bottles of "SUNDIAL***KOROMANTEE***Colonic & Intestinal Cleaner." The product was distributed in New York and was manufactured, processed, packed, held, or distributed between January 1, 2014, and May 27, 2020.
The recall is required by an Order of Permanent Injunction. The FDA has determined that the products are misbranded and deemed unapproved drugs based on the claims made on their labeling.
Consumers who have this product should stop using it and contact Sundial Herbal Products for further instructions.
The recalled product
- Product
- "SUNDIAL***KOROMANTEE***Colonic & Intestinal Cleaner***used by the descendants of the Koromantee people in Jamaica to help cleanse and strengthen the bowels, stomach, intestines, and colonic areas of the body.***" packaged in 16oz glass bottles
- 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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