FDAClass IISeptember 9, 2020

"Sundial***Traditional Jamaican***ORGANIC***Original recall: Labeling Error

"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

Why was "Sundial***Traditional Jamaican***ORGANIC***Original recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.

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
Recalling firm
Sundial Herbal Products
Quantity
Unknown
Distribution
NY
Recall date
September 9, 2020
Classification
Class II
Status
Terminated
Agency
FDA (food)
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