The Recall Desk

FDA (Food) recall action 85882

Sundial Herbal Products recalled 68 products on 2020-09-09

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.

Products
68
Announced
2020-09-09
Critical
0
Units

Why these products were recalled

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.

States named across these recalls

1–25 of 68

  • ModerateFDA (Food)··2020-09-09

    Sundial Herbal Formula Recalled for Misbranding and Unapproved Drug Claims

    Sundial Herbal Products is recalling its Traditional Herbal Formula for Flu-Allergies HayFever because the product is misbranded and deemed an unapproved drug.

    Product
    "SUNDIAL***TRADITIONAL HERBAL FORMULA***Flu-Allergies HayFever***" packaged in boxes
    Category
    Distribution
    1 state
  • ModerateFDA (Food)··2020-09-09

    Sundial Marsh Marigold Herbal Product Recalled for Misbranding

    Sundial Herbal Products is recalling Marsh Marigold herbal products under a permanent injunction because the items are misbranded and deemed unapproved drugs.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***MARSH MARIGOLD***1 oz.***USES: LIVER AILMENTS, HEPATITIS***"; packaged in clear plastic zip-top bags.
    Category
    Distribution
    1 state
  • ModerateFDA (Food)··2020-09-09

    Sundial Cinnamon Herbal Product Recalled for Misbranding and Unapproved Drug Claims

    Sundial Herbal Products is recalling 1 oz. bags of Cinnamon under a permanent injunction because the product is misbranded and deemed an unapproved drug.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***CINNAMON***1 oz.***USES: STOMACH PAIN, MUCOUS CONGESTION, COLDS, NOSE BLEED, STIMULANT, FLAVORING***"; packaged in clear plastic zip-top bags
    Category
    Distribution
    1 state
  • ModerateFDA (Food)··2020-09-09

    Sundial Bread Nut Herbal Product Recalled for Unapproved Drug Claims

    Sundial Herbal Products is recalling Bread Nut herbal products under a permanent injunction because the labeling makes unapproved drug claims.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BREAD NUT***1oz.***USES: CHOLESTEROL, OMEGA 3, BI POLAR, ANTIOXIDANT, BUILDS BONES, ACNE***"
    Category
    Distribution
    1 state
  • ModerateFDA (Food)··2020-09-09

    Sundial White Sage Herbal Product Recalled for Misbranding and Unapproved Drug Claims

    Sundial Herbal Products is recalling White Sage herbal products under a permanent injunction because the items are misbranded and deemed unapproved drugs based on labeling claims.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***WHITE SAGE***2 oz.***USES: EXCESS SWEATING, FEMALE HORMONE, SINUS INFECTION, INDIGESTION, KILLS BACTERIA***"; packaged in clear plastic zip-top bags
    Category
    Distribution
    1 state
  • ModerateFDA (Food)··2020-09-09

    Sundial Mahogany Bark Herbal Product Recalled for Unapproved Drug Claims

    Sundial Herbal Products is recalling Mahogany Bark herbal products under a permanent injunction because the items are misbranded and deemed unapproved drugs.

    Product
    SUNDIAL Traditional Herbal Products***Mahogany Bark ***2 oz.***USES: BODY WEAKNESSES, MALE REPRODUCTIVE ORGANS, INFERTILITY***" packaged in zip-top plastic bag
    Category
    Distribution
    1 state
  • ModerateFDA (Food)··2020-09-09

    Sundial African Fever Bush Recalled for Misbranding and Unapproved Drug Claims

    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.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***African Fever Bush***1oz***USES: FEVER, WORMS IN CHILDREN
    Category
    Distribution
    1 state
  • ModerateFDA (Food)··2020-09-09

    Sundial Trumpet Leaf Herbal Product Recalled for Misbranding and Unapproved Drug Claims

    Sundial Herbal Products is recalling Trumpet Leaf herbal products under a permanent injunction because the items are misbranded and deemed unapproved drugs based on labeling claims.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***TRUMPET LEAF***1 oz.***USES: DIABETES, ASTHMA, CONGESTION, SKIN BATH, ULCERS, SORES, PARKINSON'S DISEASE, KIDNEY***"; packaged in clear plastic zip-top bags
    Category
    Distribution
    1 state
  • ModerateFDA (Food)··2020-09-09

    Sundial Bay Leaves Recalled for Unapproved Drug Claims

    Sundial Herbal Products is recalling bay leaves labeled with unapproved drug claims. The FDA determined the products are misbranded and unapproved drugs.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BAY LEAVES***1 oz.***USES: COUGH, COLD, DIABETES, ACHES, PAINS, DIGESTION, FEVER, FLU SYMPTOMS***"; packaged in clear plastic zip-top bags
    Category
    Distribution
    1 state
  • ModerateFDA (Food)··2020-09-09

    Sundial Purple Sage Herbal Product Recalled for Unapproved Drug Claims

    Sundial Herbal Products is recalling Purple Sage herbal products under a permanent injunction because the labeling makes unapproved drug claims.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***PURPLE SAGE***1 oz.***USES: DEPRESSION, INSECT BITES, INSOMNIA, RELIEVES CONGESTION***"; packaged in clear plastic zip-top bags
    Category
    Distribution
    1 state
  • ModerateFDA (Food)··2020-09-09

    Sundial Devil Horsewhip Herbal Product Recalled for Misbranding

    Sundial Herbal Products is recalling Devil Horsewhip herbal products under a court order because the items are misbranded and considered unapproved drugs.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***DEVIL HORSEWHIP***1 oz.***USES: COUGH, COLD, CHEST PAIN,***FEVER, VENEREAL DISEASE***"
    Category
    Distribution
    1 state
  • ModerateFDA (Food)··2020-09-09

    Sundial African Manback Tonic Recalled for Misbranding and Unapproved Drug 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.

    Product
    "SUNDIAL***TRADITIONAL AFRICAN MANBACK TONIC***remember the strength of the reproductive organ, reflects the strength of the entire body. Take SUNDIAL AFRICAN MANBACK TONIC to strengthen, rejuvenate & energize***" packaged in glass bottles
    Category
    Distribution
    1 state
  • ModerateFDA (Food)··2020-09-09

    Sundial Herbal Products Recalls Misbranded Sarsaparilla Herbal Product

    Sundial Herbal Products is recalling Sarsaparilla herbal products under a permanent injunction because the items are misbranded and deemed unapproved drugs.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***SARSAPARILLA***2 oz.***USES: BLOOD CLEANSER, BALANCES HORMONES, PRODUCTIVE ORGANS, SYPHILIS, ECZEMA, PSORIASIS***"; packaged in clear plastic zip-top bags.
    Category
    Distribution
    1 state
  • ModerateFDA (Food)··2020-09-09

    Sundial Guava Leaf Herbal Product Recalled for Unapproved Drug Claims

    Sundial Herbal Products is recalling Guava Leaf herbal products because they are misbranded and deemed unapproved drugs based on labeling claims.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***GUAVA LEAF***1oz.***USES: BLOOD PRESSURE, WORMS, NERVES, DIABETES***"; packaged in clear plastic zip-top bags
    Category
    Distribution
    1 state
  • ModerateFDA (Food)··2020-09-09

    Sundial Fig Leaf Herbal Product Recalled for Unapproved Drug Claims

    Sundial Herbal Products is recalling Fig Leaf herbal products under a permanent injunction because the labeling makes unapproved drug claims.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***FIG LEAF***1oz.***USES: FIBER, CALCIUM, DIABETES, HIGH BLOOD PRESSURE, GENITAL WARTS, LIVER, ULCERS***"; packaged in clear zip-top bags
    Category
    Distribution
    1 state
  • ModerateFDA (Food)··2020-09-09

    Sundial Fever Grass Herbal Product Recalled for Unapproved Drug Claims

    Sundial Herbal Products is recalling Fever Grass herbal products under a court order because the labels make unapproved drug claims.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***FEVER GRASS***1oz.***USES: FEVER, COLD, MALARIA, FLU, COUGH, PNEUMONIA, HEADACHE, NERVES, STOMACH & BOWEL***"; packaged in clear plastic zip-top bags
    Category
    Distribution
    1 state
  • ModerateFDA (Food)··2020-09-09

    Sundial Organic Jamaican Turmeric Recalled for Unapproved Drug Claims

    Sundial Herbal Products is recalling Sundial Organic Jamaican Turmeric because the product is misbranded and deemed an unapproved drug due to labeling claims.

    Product
    SUNDIAL ORGANIC JAMAICAN TUMERIC; "***increases the quality and quantity of breast milk***suppresses the development of parasite that causes tumors cancer, growths, cysts & all types of cancers***"
    Category
    Distribution
    1 state
  • ModerateFDA (Food)··2020-09-09

    Sundial Sea Moss Recalled for Unapproved Drug Claims

    Sundial Herbal Products is recalling Sea Moss/Irish Moss products because they are misbranded and deemed unapproved drugs based on labeling claims.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERB***SEA MOSS/IRISH MOSS***2oz.***USES: IODINE, BREAKS UP FAT & MUCOUS, ADD, ULCERS, CALCIUM, THYROID, DETOX***"; packaged in clear plastic zip-top bags
    Category
    Distribution
    1 state
  • ModerateFDA (Food)··2020-09-09

    Sundial Herbal Products Recalls Koromantee Colonic Cleaner as Unapproved Drug

    Sundial Herbal Products is recalling Koromantee Colonic & Intestinal Cleaner because the product is misbranded and deemed an unapproved drug based on its labeling claims.

    Product
    "SUNDIAL***KOROMANTEE***Colonic & Intestinal Cleaner***used by the descendants of the Koromantee people in Jamaica to help cleanse and strengthen the bowels, stomach, intestines, and colonic areas of the body.***" packaged in 16oz glass bottles
    Category
    Distribution
    1 state
  • ModerateFDA (Food)··2020-09-09

    Sundial Herbal Asthma Formula Recalled as Unapproved Drug

    Sundial Herbal Products is recalling its Traditional Herbal Formula for Asthma because it is an unapproved drug with misbranded labeling.

    Product
    "SUNDIAL***TRADITIONAL HERBAL FORMULA***ASTHMA***" packaged in boxes
    Category
    Distribution
    1 state
  • ModerateFDA (Food)··2020-09-09

    FDA Recalls Sundial Ethiopian Tenadam Herb for Unapproved Drug Claims

    Sundial Herbal Products is recalling Sundial Ethiopian Tenadam Herb because the product is misbranded and deemed an unapproved drug based on its labeling claims.

    Product
    SUNDIAL (4 oz.) ETHIOPIAN TENADAM HERB; "***Strengthens the Vein & Capillaries***lowers high Blood pressure, regulate Heartbeat.***heals Stomach ulcers***"
    Category
    Distribution
    1 state