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.
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, 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.
See all 68 products in this recall →Related recalls
Same manufacturer · Sundial Herbal Products
See all →- ModerateSundial Marsh Marigold Herbal Product Recalled for Misbranding
FDA (Food) · 2020-09-09
- ModerateSundial Herbal Blood Pressure Formula Recalled for Misbranding and Unapproved Drug Status
FDA (Food) · 2020-09-09
- ModerateSundial Cinnamon Herbal Product Recalled for Misbranding and Unapproved Drug Claims
FDA (Food) · 2020-09-09
- ModerateSundial Bread Nut Herbal Product Recalled for Unapproved Drug Claims
FDA (Food) · 2020-09-09
- ModerateSundial White Sage Herbal Product Recalled for Misbranding and Unapproved Drug Claims
FDA (Food) · 2020-09-09
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02