Sundial Hemp Seed Oil Recalled for Misbranding and Unapproved Drug Claims
Sundial Herbal Products is recalling Sundial Hemp Seed Oil because the product is misbranded and deemed an unapproved drug based on its labeling claims.
What this means for you
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 Hemp Seed Oil under a permanent injunction order. The U.S. Food and Drug Administration has determined that the product is misbranded and is deemed an unapproved drug due to specific claims made on its labeling.
The recall covers products manufactured, processed, packed, held, or distributed between January 1, 2014, and May 27, 2020. Distribution was limited to New York. The agency has classified this recall as Class II.
Consumers who have purchased this product should stop using it and follow instructions from the recalling firm or the FDA regarding disposal or return.
The recalled product
- Product
- "SUNDIAL***Hemp Seed Oil***"
- Manufacturer
- Sundial Herbal Products
- Category
- Food — 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.
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