Sundial Ethiopian Traditional Talba Recalled for Misbranding and Unapproved Drug Claims
Sundial Herbal Products is recalling Ethiopian Traditional Talba (Flaxseed Meal Cereal) 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 minor labeling errors or low-risk contamination without reported injuries.
Plain-English summary
Sundial Herbal Products is recalling SUNDIAL Ethiopian Traditional Talba (Flaxseed Meal Cereal) under a permanent injunction. The recall is required because the products are misbranded and deemed unapproved drugs based on the claims made on their labels.
The recall covers products manufactured, processed, packed, held, and/or distributed between January 1, 2014, and May 27, 2020. The distribution pattern is listed as New York (NY).
Consumers who have 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***Ethiopian Traditional Talba (Flaxseed Meal Cereal)***"
- Manufacturer
- Sundial Herbal Products
- Category
- Food — Cereal / Grain
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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