STATES:  Nationwide; Internet
RECALL:   ALL Sundial products (65) were misbranded; are unapproved drugs; Recall required by Order as of 7/9/2020.  
"To be in compliance with FDA Drug Regulations, Sundial is requesting an immediate recall, removal and return, of all Sundial Products, distributed from the period beginning January 1, 2014 through current, that have labeling containing/making drug claims stating the product(s) can diagnose, cure, mitigate, treat or prevent disease. The recalled drug products are misbranded and deemed unapproved drugs based on labeling claims which could result in a delay of appropriate treatment by a healthcare provider. Because these products are unapproved, their safety and efficacy have not been established. While specific risks to patients, from use of these adulterated products, cannot always be identified or assessed, it is also not possible to rule out patient risks resulting from the use of such products."

"All products used as a Sundial Herbs can be identified by the “Sundial” label with brown glass bottles, boxes, Ziploc bags and paper bags with clear viewing windows. This was distributed state or nationwide via the Sundial Herb website (External Link Disclaimerhttp://sundialherbs.com/sundial/External Link Disclaimer)External Link Disclaimer, or any other website or store pick up at 3609 Boston Road, Bronx, New York. Please contact Sundial Herbs to schedule return orders for proper disposal and destruction of the products.

The Sundial Herb company is halting product distribution of all products on their website and in their store location. Sundial Herbs recommends stopping use of these recalled products. No illnesses have been reported to date. However, if consumers have problems that may be linked to Sundial Herbs they should contact a Doctor immediately.

Your immediate action, and response, is required. For questions or assistance in carrying out the request, please call Sundial (718) 798-3962."

List of 65 Products follows.  ACTION, CONTACT, & H4H NOTE FOLLOW DIRECTLY BELOW LIST

Tenadam Herb          Flax Seed Oil & Honey Blend          Mitmitta (Cayenne Pepper)

Spiced Tea          Bitter Kola (Arogbo)          Mahogany Bark

Nigerian Moringa Leaf Powder          Jamaican Bissy Powder          Chaney Root

Jamaican Turmeric          Ghanian Black Spice          Cerasee Bay Leaves, Mango Bark

Bitter Wood          Piss A Bed           Asthma

Devil Horsewhip          White Pond Lily          Blood Pressure

Mango Leaf          Purple Sage          Heart

Red Water Grass          Quassia Wood          Worms and Parasites

Sarsaparilla          Trumpet Leaf          Flu-Allergies /HayFever

Marsh Marigold          White Jointa          Arthritis

Sea Moss/Irish Moss          White Sage          Axum Traditional Ethiopian Honey Beverage

Dog Blood          Guinea Hen Weed          Black Sage

Guava Leaf          Sundial Cassava Meal          Black Wiss

Jack in the Bush          Cocoa Balls           Cinnamon

King of the Forest          African Fever Bush          Palo De Brazil

ETHIOPIAN ABISH (FENNUGREEK SEED PWD.)          Mojo Bush          Broom Weed

Ethiopian Traditional Talba (Flaxseed Meal Cereal)          Blood Leaf          Bread Nut

Fever Grass           Wood & Root Tonic          Jamaican and Tropical Raw Honey

Jamaican Milk Wiss          Koromantee          Hemp Seed Oil

Spanish Needle          Ashanti          Talibah’s Tooth Powder and Ethiopian Coffe

Fig Leaf          African Manback Tonic          Blue Vervain

Diabetics          Pimento

 

ACTION:  Discontinue use; return

 

CONTACT:   Sundial Herbal Products via email: atsundialherbalproducts@aol.com; phone: 718-798-1263

Source:   FDA Recall

H4H Note:   www.sundialherbs.com website reads:  "We'll Be Back SOON!.  We regret to announce that Sundialherbs.com is undergoing construction.  We'll be back shortly.  Sorry for the inconvenience this may cause.  Thank you for your understanding. Please contact us at 718-798-3962 or sundialoffice3609@gmail.com.  You're Welcome to come to our location in the Bronx:  Sundial Herbal Products, 3609 Boston Road, Bronx, NY 10466.  Thank you for over 30 years of support since 1979!

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