Sundial Herbal Products Recalls Misbranded Sarsaparilla Herbal Product
Sundial Herbal Products is recalling Sarsaparilla 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, which aligns with the rubric for moderate severity involving labeling errors or regulatory violations without reported injuries.
Plain-English summary
Sundial Herbal Products is recalling Sarsaparilla herbal products, packaged in clear plastic zip-top bags. The recall is required by an Order of Permanent Injunction.
The FDA determined that the products are misbranded and deemed unapproved drugs based on their labeling claims. The affected products were manufactured, processed, packed, held, and/or distributed between January 1, 2014, and May 27, 2020.
The recall is limited to New York. Consumers should stop using the product and contact the recalling firm for instructions.
The recalled product
- Product
- "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***SARSAPARILLA***2 oz.***USES: BLOOD CLEANSER, BALANCES HORMONES, PRODUCTIVE ORGANS, SYPHILIS, ECZEMA, PSORIASIS***"; 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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