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.

101–125 of 547

  • 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
  • ModerateFDA (Food)·F-1495-2020·2020-09-09

    Sundial Traditional Herbal Formula Heart Recalled for Misbranding

    Sundial Herbal Products is recalling its Traditional Herbal Formula Heart product because it is misbranded and deemed an unapproved drug.

    Product
    "SUNDIAL***TRADITIONAL HERBAL FORMULA***HEART***" packaged in boxes
    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-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-1500-2020·2020-09-09

    Sundial Cassava Meal Recalled as Unapproved Drug

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

    Product
    "SUNDIAL***CASSAVA MEAL***" packaged in brown bags with a clear viewing window
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1450-2020·2020-09-09

    Sundial Chaney Root Herbal Product Recalled for Unapproved Drug Claims

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

    Product
    SUNDIAL Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***CHANEY ROOT***2oz.***USES: BLOOD CLEANSER, SKIN PROBLEMS, SYPHILIS, RHEUMATISM, ARTHRITIS
    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-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-1444-2020·2020-09-09

    Sundial Herbal Products Recalls Ethiopian Flax Seed Oil and Honey Blend

    Sundial Herbal Products is recalling Ethiopian Flax Seed Oil & Honey Blend because it is misbranded and deemed an unapproved drug.

    Product
    ETHIOPIAN FLAX SEED OIL & HONEY BLEND; "***clears bladder, kidney, urinary tract prostate womb and colon, sooths stomach, lowers cholesterol and blood pressure***DIST. BY: SUNDIAL HERBAL PRODUCTS***"
    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-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-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-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-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-1488-2020·2020-09-09

    Sundial Wood and Root Tonic Recalled for Misbranding and Unapproved Drug Claims

    Sundial Herbal Products is recalling Wood and Root Tonic under a permanent injunction because the product is misbranded and deemed an unapproved drug.

    Product
    "Sundial***Traditional Jamaican***ORGANIC***Original Maroon Recipe***WOOD AND ROOT TONIC***used for centuries in Jamaica as a household remedy, to cleanse the body and the blood of mucus, and toxic waste.***used by the Carib Indians of Central America to Protect them against epid
    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-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-1447-2020·2020-09-09

    Sundial Herbal Products Recalls Ghanian Black Spice for Unapproved Drug Claims

    Sundial Herbal Products is recalling Ghanian Black Spice because the product is misbranded and deemed an unapproved drug due to labeling claims.

    Product
    Ghanian Black Spice; "***USES:***DYSENTERY, DIARRHEA, RHEUMATISM, FACILITATES CHILDBIRTH***"
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1494-2020·2020-09-09

    Sundial Herbal Blood Pressure Formula Recalled for Misbranding and Unapproved Drug Status

    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.

    Product
    "SUNDIAL***TRADITIONAL HERBAL FORMULA***BLOOD PRESSURE***" packaged in boxes
    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-1487-2020·2020-09-09

    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
    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