Sundial Herbal Products

Recall #F-1456-2020 · Initiated 2020-06-30

Plain-language summary

by FoodRecallsDB.info

What happened

Sundial Herbal Products' Mango Leaf product is being recalled because the company made health claims on the label (such as treating kidney stones and high blood pressure) without FDA approval. These types of medical claims require the product to be approved as a drug, not sold as an herbal supplement.

Who is at risk

Anyone who purchased this product in New York should be aware of this recall.

What to do

Stop using this product and do not consume it. If you have this item, you can dispose of it or contact the retailer where you purchased it. If you have health concerns related to kidney stones, high blood pressure, or nervous conditions, consult your doctor rather than relying on unapproved herbal remedies.

Product

"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***MANGO LEAF***1 oz.***USES: KIDNEY STONES, HIGH BLOOD PRESSURE, RELATED TO NERVOUS CONDITIONS***"

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

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