Sundial Cassava Meal Recalled as Unapproved Drug
Sundial Herbal Products is recalling Sundial Cassava Meal 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 claims without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Sundial Herbal Products is recalling Sundial Cassava Meal, which is packaged in brown bags with a clear viewing window. 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. The recall covers product manufactured, processed, packed, held, and/or distributed during the time period beginning January 1, 2014, through May 27, 2020.
The distribution pattern for this recall is New York (NY). Consumers should stop using the product and follow instructions from the recalling firm or the FDA regarding disposal or return.
The recalled product
- Product
- "SUNDIAL***CASSAVA MEAL***" packaged in brown bags with a clear viewing window
- Manufacturer
- Sundial Herbal Products
- Category
- Food — Cassava Meal
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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