Sundial Mahogany Bark Herbal Product Recalled for Unapproved Drug Claims
Sundial Herbal Products is recalling Mahogany Bark herbal products under a permanent injunction because the items are misbranded and deemed unapproved drugs.
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 illnesses or injuries, fitting the criteria for moderate severity.
Plain-English summary
Sundial Herbal Products is recalling SUNDIAL Traditional Herbal Products Mahogany Bark, 2 oz., packaged in zip-top plastic bags. 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 their labeling claims. The product labels include uses for body weaknesses, male reproductive organs, and infertility.
The affected products were manufactured, processed, packed, held, and/or distributed during the time period beginning January 1, 2014, through May 27, 2020. The distribution pattern is listed as New York (NY). Consumers should stop using the product and follow instructions from the recalling firm or the FDA.
The recalled product
- Product
- SUNDIAL Traditional Herbal Products***Mahogany Bark ***2 oz.***USES: BODY WEAKNESSES, MALE REPRODUCTIVE ORGANS, INFERTILITY***" packaged in zip-top plastic bag
- 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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