Sundial Herbal Products are being recalled for unapproved drugs to be in compliance with FDA Drug Regulations. These recalled products are misbranded because they have labeling claims that could result in delay of appropriate treatment by a healthcare provider. Because these dietary supplements are unapproved, their safety and efficacy have not been established. No illnesses or adverse reactions have been reported by the company to date. The recall headline states that “recall is required by the order.”
All products used as Sundial Herbs can be identified with the “Sundial” label. They were sold in brown glass bottles, boxes, ziplock bags, and paper bags wit clear viewing windows. They were distributed nationwide or statewide through the Sundial Herb website or any other website. They were also sold through store pick up at 3609 Boston Road in the Bronx, New York City.
You can see the long list of recalled products at the FDA web site. They include Tenadam Herb, White Pond Lily, Mango Leaf, Red Water Grass, Dog Blood, Ethiopian Traditional Talba (Flaxseed Meal Cereal), Fever Grass, Mojo Bush, Bread Nut, Bliss Wiss, Flu-Allergies/HayFever, Asthma, Arthritis, Chaney Root, and Mahogany Bark, among others. No pictures of the recalled products are available.
Sundial Herb is halting production and distribution of all products on their website and in their store location. If you purchased any of these recalled Sundial Herbal Products, stop using them. If you have any adverse reactions, see your doctor. The recall notice states, “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.”
You should then report those reactions to the FDA through the FDA’s MedWatch Adverse Event Reporting System. You can do this online, through the mail, or by fax.
