Sundial Broom Weed Herbal Product Recalled for Misbranding and Unapproved Drug Claims
Sundial Herbal Products is recalling Broom Weed herbal products under a permanent injunction because the items are misbranded and deemed unapproved drugs.
The agency’s classification
FDA (Food): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the hazard is primarily regulatory (misbranding/unapproved drug status) rather than a confirmed physical or chemical contamination risk.
Plain-English summary
Sundial Herbal Products is recalling its Broom Weed herbal products, which are packaged in clear plastic zip-top bags. The recall is required by an Order of Permanent Injunction issued by the U.S. Food and Drug Administration.
The FDA determined that the products are misbranded and deemed unapproved drugs based on their labeling claims. The product labeling includes uses such as breaking up infection in the bladder and reproductive system, treating venereal disease, and treating fever.
The recall covers products manufactured, processed, packed, held, and/or distributed between January 1, 2014, and 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***TRADITIONAL ORGANIC HERBS***BROOM WEED***1oz.***USES: BREAKS UP INFECTION IN BLADDER & REPRODUCTIVE SYTSEM, VENEREAL DISEASE, FEVER***"; packaged in clear plastic zip-top bags
- Manufacturer
- Sundial Herbal Products
- Category
- Drug — Herbal Supplement
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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