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Class II

Sundial Herbal Products

Recall #F-1443-2020 · Initiated 2020-06-30

Plain-language summary

by FoodRecallsDB.info
What happened
The FDA ordered a recall of Sundial Organic Jamaican Turmeric products because the company made health claims on the label that are not approved by the FDA, such as claims that it increases breast milk production or treats cancer. The product is being recalled because these claims make it an unapproved drug rather than a legal dietary supplement or food.
Who is at risk
Anyone who purchased this product in New York should be aware of this recall.
What to do
If you have this product, stop using it and contact the company or your retailer for a refund. Do not rely on this product for any medical condition, and speak with your doctor if you have health concerns.
Product
SUNDIAL ORGANIC JAMAICAN TUMERIC; "***increases the quality and quantity of breast milk***suppresses the development of parasite that causes tumors cancer, growths, cysts & all types of cancers***"
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.

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