Sundial Mango Bark Herbal Product Recalled for Unapproved Drug Claims
Sundial Herbal Products is recalling Mango Bark herbal products because they are misbranded and deemed unapproved drugs based on 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 mislabeling and unapproved drug claims without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Sundial Herbal Products is recalling 2 oz. bottles of Traditional Organic Herbs Mango Bark. The product is labeled with uses for kidney stones, high blood pressure, and conditions related to the nervous system.
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 these specific labeling claims.
The affected products were manufactured, processed, packed, held, and/or distributed between January 1, 2014, and May 27, 2020. Distribution was limited to New York. Consumers should stop using the product and follow instructions from the recalling firm or the FDA.
The recalled product
- Product
- "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***MANGO BARK***2 oz.***USES: KIDNEY STONE, HIGH BLOOD PRESSURE, RELATED TO NERVOUS CONDITIONS***"
- 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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