The Recall Desk

Hazard

Unapproved Drug recalls

547 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
547
Critical
146
Severe
195
Most recent
2026-08-19

Of the 547 unapproved drug recalls we have scored against our rubric, 146 (27%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 195 (36%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all unapproved drug recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

126–150 of 547

  • ModerateFDA (Food)·F-1449-2020·2020-09-09

    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
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1454-2020·2020-09-09

    Sundial Bitter Wood Herbal Product Recalled for Unapproved Drug Claims

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

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BITTER WOOD***2 oz.***USES: EXPELS WORMS IN THE WEST INTESTINES, DESTROYS PARASITES, LEUKEMIA, DESTROY APPETITE FOR ALCOHOL***"
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1462-2020·2020-09-09

    Sundial Black Sage Herbal Product Recalled for Unapproved Drug Claims

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

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BLACK SAGE***1 oz.***USES: ALZHEIMER'S DISEASE, GINGIVITIS, MENOPAUSE, APPLY DIRECTLY TO SKIN FOR COLD SORES, ASTHMA***"; packaged in clear plastic zip-top bags
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1446-2020·2020-09-09

    Sundial Herbal Products Recalls Jamaican Bissy Powder for Unapproved Drug Claims

    Sundial Herbal Products is recalling Jamaican Bissy Powder because the product is misbranded and deemed an unapproved drug based on its labeling claims.

    Product
    Jamaican Bissy Powder; "***Bissy regulates the heart, removes and prevents water from settling around the heart, lessens the desire for drugs, cigarettes, alcohol by clearing the body and blood of poison viruses & toxins etc. Relieves fatigue gives stamina and endurance enabling
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1474-2020·2020-09-09

    Sundial Herbal Products Recalls Piss A Bed for Unapproved Drug Claims

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

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***PISS A BED***1 oz.***USES: LIVER TONIC, ARTHRITIS, RHEUMATISM, KIDNEY, BLADDER, JAUNDICE***"; packaged in clear plastic zip-top bags
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1456-2020·2020-09-09

    Sundial Mango Leaf Herbal Product Recalled for Unapproved Drug Claims

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

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***MANGO LEAF***1 oz.***USES: KIDNEY STONES, HIGH BLOOD PRESSURE, RELATED TO NERVOUS CONDITIONS***"
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1440-2020·2020-09-09

    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
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1481-2020·2020-09-09

    Sundial Herbal Products Recalls Guinea Hen Weed for Unapproved Drug Claims

    Sundial Herbal Products is recalling Guinea Hen Weed herbal products under a permanent injunction because the labeling makes unapproved drug claims.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***GUINEA HEN WEED***1 oz.***USES: ARTHRITIS, RHEUMATISM, STIMULATE IMMUNE SYSTEM, FIGHTS CANCER CELLS, VIRUSES, YEAST***"; packaged in clear plastic zip-top bags
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1460-2020·2020-09-09

    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
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1443-2020·2020-09-09

    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
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1468-2020·2020-09-09

    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
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1471-2020·2020-09-09

    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
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1448-2020·2020-09-09

    Sundial Herbal Products Recalls Mitmitta Cayenne Pepper Product

    Sundial Herbal Products is recalling Mitmitta (Cayenne Pepper) because it is misbranded and deemed an unapproved drug due to labeling claims.

    Product
    Mitmitta (Cayenne Pepper); "Traditional Uses: Prevents heart attacks, and lowers high blood pressure, stops internal bleeding, Heals ulcers and pains there of: Improves circulation, thins blood and keeps it moving***"
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1482-2020·2020-09-09

    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
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1489-2020·2020-09-09

    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
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1493-2020·2020-09-09

    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
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1458-2020·2020-09-09

    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
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1483-2020·2020-09-09

    Sundial Herbal Products Recalls Jack in the Bush Due to Misbranding

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

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***JACK IN THE BUSH***1oz.***USES: COLD MEDICINE (ESP. IN CHILDREN), CALMS THE NERVES, RELIEVES DEPRESSION***"; packaged in clear plastic zip-top bags
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1491-2020·2020-09-09

    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
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1475-2020·2020-09-09

    Sundial White Pond Lily Herbal Product Recalled for Misbranding

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

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***WHITE POND LILY***1oz.***USES: CANCER, DOUCHE, TUBERCULOSIS IN LYMPH GLANDS, GONORRHEA, ULCER IN MOUTH & THROAT***"; packaged in clear plastic zip-top bags
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1455-2020·2020-09-09

    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
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1457-2020·2020-09-09

    Sundial Red Water Grass Herbal Product Recalled for Misbranding

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

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***RED WATER GRASS***1 oz.***USES: FEMALE PROBLEMS, FIBROIDS, INFERTILITY, HIGH BLOOD PRESSURE***" packaged in clear plastic zip-top bags
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1476-2020·2020-09-09

    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
    Food
    Distribution
    1 state