Sundial Pimento Herbal Product Recalled for Misbranding and Unapproved Drug Claims
Sundial Herbal Products is recalling Pimento herbal products under a permanent injunction. The items are misbranded and deemed unapproved drugs due to specific 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 its "Sundial Traditional Herbal Products" Pimento, packaged in clear plastic zip-top bags. The recall is required by an Order of Permanent Injunction. The product was 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 their labeling claims. The packaging lists uses including stimulant, diabetes, worms, prevents strokes, reduces tobacco urge, and warms body. These claims cause the product to be classified as a drug, which it is not approved to be.
Consumers who purchased this product should stop using it and return it to the place of purchase for a refund or contact the recalling firm for further instructions.
The recalled product
- Product
- "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***PIMENTO***1 oz.***USES: STIMULANT, DIABETES, WORMS, PREVENTS STROKES, REDUCES TOBACCO URGE, WARMS BODY***"; packaged in clear plastic zip-top bags
- Manufacturer
- Sundial Herbal Products
- Category
- Drug — 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.
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