Home / Sundial Herbal Products / F-1488-2020
Class II
Sundial Herbal Products
Recall #F-1488-2020 · Initiated 2020-06-30
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 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.
Quantity affected
Unknown
Distribution
NY
Lot / code info
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Voluntary / mandated
FDA Mandated
Initial notification
Letter
Terminated
2022-10-26
Recalling firm
Sundial Herbal Products
3609 Boston Rd
Bronx, NY 10466-5810
United States
Recall classification
Remote probability of serious adverse health consequences, or temporary reversible consequences.
Other recalls from Sundial Herbal Products
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***WHITE JOINTA***1 oz.***USES: NERVES, COLD, ASTHMA, …
SUNDIAL NIGERIAN MORINGA LEAF POWDER; "***Anti-inflammatory, builds Red Blood cells***" 4oz and 8oz jars
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***DOG BLOOD***1 oz.***USES: FIBROIDS, CYST, CLEANS WO…
Jamaican Bissy Powder; "***Bissy regulates the heart, removes and prevents water from settling around the heart, lessens…