Sundial Bread Nut Herbal Product Recalled for Unapproved Drug Claims
Sundial Herbal Products is recalling Bread Nut herbal products under a permanent injunction because the labeling makes unapproved drug 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, but the source text attributes the recall to misbranding and unapproved drug claims rather than a specific contamination or injury event, fitting the criteria for moderate severity related to labeling and regulatory status.
Plain-English summary
Sundial Herbal Products is recalling its Bread Nut traditional organic herbs product, a 1-ounce herbal product. The recall is required by an Order of Permanent Injunction.
The FDA determined that the products are misbranded and deemed unapproved drugs based on the labeling claims. The source text does not specify the exact nature of the health claims or the specific distribution locations beyond the structured metadata indicating New York.
Consumers who have purchased 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***BREAD NUT***1oz.***USES: CHOLESTEROL, OMEGA 3, BI POLAR, ANTIOXIDANT, BUILDS BONES, ACNE***"
- Manufacturer
- Sundial Herbal Products
- Category
- Food — 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.
See all 68 products in this recall →Related recalls
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