FDA (Food) recall action 85882
The FDA (Food) publishes a recall like this one as 68 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 68 pages.
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
The agency’s own wording, quoted from the enforcement report.
Sundial Herbal Products is recalling Bitter Wood herbal products under a court order because the labels make unapproved drug claims.
Sundial Herbal Products is recalling Jack in the Bush herbal products under a permanent injunction because the items are misbranded and deemed unapproved drugs.
Sundial Herbal Products is recalling Broom Weed herbal products under a permanent injunction because the items are misbranded and deemed unapproved drugs.
Sundial Herbal Products is recalling Pimento herbal products under a permanent injunction. The items are misbranded and deemed unapproved drugs due to specific labeling claims.
Sundial Herbal Products is recalling Devil Horsewhip herbal products under a court order because the items are misbranded and considered unapproved drugs.
Sundial Herbal Products is recalling Mango Leaf herbal products because they are misbranded and deemed unapproved drugs based on labeling claims.
Sundial Herbal Products is recalling bay leaves labeled with unapproved drug claims. The FDA determined the products are misbranded and unapproved drugs.
Sundial Herbal Products is recalling Spanish Needle herbal products under a permanent injunction because the items are misbranded and deemed unapproved drugs.
Sundial Herbal Products is recalling Koromantee Colonic & Intestinal Cleaner because the product is misbranded and deemed an unapproved drug based on its labeling claims.
Sundial Herbal Products is recalling Piss A Bed herbal products under a permanent injunction because the products are misbranded and deemed unapproved drugs.
Sundial Herbal Products is recalling African Fever Bush under a permanent injunction because the product is misbranded and deemed an unapproved drug based on its labeling claims.
Sundial Herbal Products is recalling Axum Ethiopian Honey Beverage because it is misbranded and deemed an unapproved drug based on labeling claims.
Sundial Herbal Products is recalling White Jointa herbal products under a permanent injunction because the items are misbranded and deemed unapproved drugs.
Sundial Herbal Products is recalling Sundial Nigerian Moringa Leaf Powder because the product is misbranded and deemed an unapproved drug due to specific labeling claims.
Sundial Herbal Products is recalling Sundial Organic Jamaican Turmeric because the product is misbranded and deemed an unapproved drug due to labeling claims.
Sundial Herbal Products is recalling Talibah's Tooth Powder because the product is misbranded and deemed an unapproved drug based on its labeling claims.
Sundial Herbal Products is recalling its Traditional Herbal Formula for Arthritis because the product is misbranded and considered an unapproved drug.
Sundial Herbal Products is recalling Purple Sage herbal products under a permanent injunction because the labeling makes unapproved drug claims.
Sundial Herbal Products is recalling Mojo Bush herbal products under a permanent injunction because the items are misbranded and deemed unapproved drugs.
Sundial Herbal Products is recalling White Pond Lily herbal products under a permanent injunction because the items are misbranded and deemed unapproved drugs.
Sundial Herbal Products is recalling its Traditional Herbal Formula for Worms & Parasites because the product is misbranded and deemed an unapproved drug.
Sundial Herbal Products is recalling Sundial Traditional Herbal Formula Blood Pressure boxes under a permanent injunction. The products are misbranded and deemed unapproved drugs due to labeling claims.
Sundial Herbal Products is recalling Sundial Traditional African Manback Tonic because the product is misbranded and deemed an unapproved drug based on its labeling claims.
Sundial Herbal Products is recalling Sarsaparilla herbal products under a permanent injunction because the items are misbranded and deemed unapproved drugs.
Sundial Herbal Products is recalling Cerasee herbal products under a permanent injunction because the items are misbranded and considered unapproved drugs.