Sundial Jamaican Raw Honey Recalled for Unapproved Drug Claims
Sundial Herbal Products is recalling Sundial Jamaican & Tropical Raw Honey because it 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 claims, which aligns with the rubric for moderate severity involving labeling errors or regulatory violations without reported acute physical harm.
Plain-English summary
Sundial Herbal Products is recalling Sundial Jamaican & Tropical Raw Honey. The recall is required by an Order of Permanent Injunction. The product is distributed in New York and was manufactured, processed, packed, held, 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 the claims made on their labeling. This classification indicates that the product is being marketed with drug claims without the necessary approval.
Consumers who have purchased this product should stop using it and follow the instructions provided by the recalling firm or the FDA for disposal or return.
The recalled product
- Product
- "SUNDIAL***Jamaican & Tropical Raw Honey***"
- Manufacturer
- Sundial Herbal Products
- Category
- Food — Honey
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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