- Company Announcement Date:
- July 09, 2020
- FDA Publish Date:
- July 09, 2020
- Product Type:
- Food & Beverages
Spices, Flavors & Salts
- Reason for Announcement:
Recall Reason Description
Misbranding & Unapproved New Drugs
- Company Name:
- Sundial Herbal Products
- Brand Name:
- Product Description:
Herbal Products/Dietary Supplements
To all Stores, Vendors and Customers:
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.
The products included for recall are:
|Flax Seed Oil & Honey Blend
|Mitmitta (Cayenne Pepper)
|Bitter Kola (Arogbo)
|Nigerian Moringa Leaf Powder
|Jamaican Bissy Powder
|Ghanian Black Spice
|Cerasee Bay Leaves, Mango Bark
|Piss A Bed
|White Pond Lily
|Red Water Grass
|Worms and Parasites
|Sea Moss/Irish Moss
|Axum Traditional Ethiopian Honey Beverage
|Guinea Hen Weed
|Sundial Cassava Meal
|Jack in the Bush
|King of the Forest
|African Fever Bush
|Palo De Brazil
|ETHIOPIAN ABISH (FENNUGREEK SEED PWD.)
|Ethiopian Traditional Talba (Flaxseed Meal Cereal)
|Wood & Root Tonic
|Jamaican and Tropical Raw Honey
|Jamaican Milk Wiss
|Hemp Seed Oil
|Talibah’s Tooth Powder and Ethiopian Coffe
|African Manback Tonic
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 (http://sundialherbs.com/sundial/), 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.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Consumers with further questions may contact Sundial Herbal Products via email [email protected] .
Company Contact Information
- Christine M. Humphrey Esq.