Sundial Wood and Root Tonic Recalled for Misbranding and Unapproved Drug Claims
Sundial Herbal Products is recalling Wood and Root Tonic under a permanent injunction because the product is misbranded and deemed an unapproved drug.
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 and involves misbranding and unapproved drug claims. Per the rubric, minor labeling errors and regulatory violations without reported physical injuries or illnesses fall under the Moderate category.
Plain-English summary
Sundial Herbal Products is recalling its Wood and Root Tonic, a 16-ounce herbal product, under a permanent injunction. The recall is required by the U.S. Food and Drug Administration because 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. The product contains ingredients such as Chaney Root, Sarsparilla Root, Black Wis, Milk Wiss, African Cayenne, Sour Sop Leaf, Mango Leaf, Cloves, Pimento, and Cinnamon.
Consumers who have purchased this product should stop using it and contact Sundial Herbal Products for further instructions. The recall is administrative in nature, addressing regulatory violations regarding the product's status and labeling rather than a specific physical safety hazard like contamination or injury.
The recalled product
- Product
- "Sundial***Traditional Jamaican***ORGANIC***Original Maroon Recipe***WOOD AND ROOT TONIC***used for centuries in Jamaica as a household remedy, to cleanse the body and the blood of mucus, and toxic waste.***used by the Carib Indians of Central America to Protect them against…
- 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 →- High
- ModerateRecall of MPR Single Use Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
- ModeratePercussionaire Recalls Intrapulmonary Percussive Ventilation Devices Due to Labeling Warning
FDA (Devices) · 2026-10-07
- ModerateASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
- ModerateASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateIowa Select Herbs Recalls Ashwaganda Root Due to Misbranding and Adulteration
FDA (Food) · 2016-05-11
- ModerateIowa Select Herbs Recalls Sassafras Root Bark Due to Misbranding
FDA (Food) · 2016-05-11
- ModerateIowa Select Herbs Recalls Valerian Root for Misbranding and Adulteration
FDA (Food) · 2016-05-11
- LowIowa Select Herbs Recalls Blood Root Supplement Due to Misbranding
FDA (Food) · 2016-05-11
- SevereFDA Recalls Unapproved Miraculous Evil Root Capsules Containing Sildenafil
FDA (Drugs) · 2018-02-07
- ModerateIowa Select Herbs Recalls Red Ginseng Root for Misbranding and Adulteration
FDA (Food) · 2016-05-11