PlainRecalls
FDA Food Moderate Class II Terminated

"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 epidemics***INGREDIENTS: Purified, Filtered & Distilled Water Chaney Root, Sarsparilla Root, Black Wis, Milk Wiss, African Cayenne, Sour Sop Leaf, Mango Leaf, Cloves, Pimento, Cinnamon***" packaged in 16oz bottles

Reported: September 9, 2020 Initiated: June 30, 2020 #F-1488-2020

Product Description

"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 epidemics***INGREDIENTS: Purified, Filtered & Distilled Water Chaney Root, Sarsparilla Root, Black Wis, Milk Wiss, African Cayenne, Sour Sop Leaf, Mango Leaf, Cloves, Pimento, Cinnamon***" packaged in 16oz bottles

Reason for Recall

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

Details

Recalling Firm
Sundial Herbal Products
Units Affected
Unknown
Distribution
NY
Location
Bronx, NY

Frequently Asked Questions

What product was recalled?
"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 epidemics***INGREDIENTS: Purified, Filtered & Distilled Water Chaney Root, Sarsparilla Root, Black Wis, Milk Wiss, African Cayenne, Sour Sop Leaf, Mango Leaf, Cloves, Pimento, Cinnamon***" packaged in 16oz bottles. Recalled by Sundial Herbal Products. Units affected: Unknown.
Why was this product recalled?
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
Which agency issued this recall?
This recall was issued by the FDA Food on September 9, 2020. Severity: Moderate. Recall number: F-1488-2020.