MODERATE RISK
Terminated
F-1488-2020
"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
Classification
Class II — Products that might cause a temporary health problem, or pose only a slight threat of a serious nature.
Reason for Recall
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
Product Details
Product Quantity
Unknown
Product Type
Food
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
Distribution & Geography
Distribution Pattern
NY
Company Location
Bronx, NY, 10466-5810
Timeline
Report Date
09/09/2020
Recall Initiated
06/30/2020
Classification Date
09/15/2020
Termination Date
10/26/2022
Source: U.S. Food & Drug Administration (FDA) — FDA Recalls
Last updated: August 28, 2026
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