Sundial Herbs and Herbal Products Enterprise

FEI 1000119548 · 3609 Boston Rd, Bronx, New York, 10466-5810, United States

1 warning letter on record

Per FDA, as of 2026-10-31 · Sources: FDA Data Dashboard, Import Alerts, Enforcement Reports

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Import alerts

Import refusals (5 years)

Warning letters

Last FDA action

2025-06-25

1 year ago

FDA record

2025-06-25
InspectionFDA inspection · Classification: No Action Indicated (NAI)
Project area: Food Composition, Standards, Labeling and Econ
FDA source
2025-06-25
InspectionFDA inspection · Classification: No Action Indicated (NAI)
Project area: Foodborne Biological Hazards
FDA source
2021-04-19
InspectionFDA inspection · Classification: No Action Indicated (NAI)
Project area: Food Composition, Standards, Labeling and Econ
FDA source
2021-04-19
InspectionFDA inspection · Classification: No Action Indicated (NAI)
Project area: Foodborne Biological Hazards
FDA source
2020-06-30
RecallRecall F-1440-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
SUNDIAL (4 oz.) ETHIOPIAN TENADAM HERB; "***Strengthens the Vein & Capillaries***lowers high Blood pressure, regulate Heartbeat.***heals Stomach ulcers***"
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1441-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
SUNDIAL PRINCESS ALMAZ Traditional ETHIOPIAN Organic SPICED TEA; "***Improves circulation***eliminates gas stomach griping & cramps. Relieves acid reflux, coughs, flu, hay fever, allergies, breaks up mucus and fights infection***" packaged …
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1442-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
SUNDIAL NIGERIAN MORINGA LEAF POWDER; "***Anti-inflammatory, builds Red Blood cells***" 4oz and 8oz jars
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1443-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
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***"
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1444-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
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***"
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1445-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
Bitter Kola (Arogbo); "***a Natural Antibiotic kills all bacteria, virus, Infections and prevent them***it's a good antidote to all poisons, it's used against stomach problem like EBOLA, Colitis, Diarrhea; dysentery etc. It suppresses the B…
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1446-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
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 fatig…
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1447-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
Ghanian Black Spice; "***USES:***DYSENTERY, DIARRHEA, RHEUMATISM, FACILITATES CHILDBIRTH***"
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1448-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
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***"
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1449-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
SUNDIAL Traditional Herbal Products***Mahogany Bark ***2 oz.***USES: BODY WEAKNESSES, MALE REPRODUCTIVE ORGANS, INFERTILITY***" packaged in zip-top plastic bag
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1450-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
SUNDIAL Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***CHANEY ROOT***2oz.***USES: BLOOD CLEANSER, SKIN PROBLEMS, SYPHILIS, RHEUMATISM, ARTHRITIS
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1451-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"SUNDIAL Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***CERASEE***1 oz.***USES: DIABETES, HYPERTENSION, WORMS, DYSENTERY, MALARIA, BLOOD PURIFIER"; packaged in clear zip-top bags
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1452-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"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
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1453-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***MANGO BARK***2 oz.***USES: KIDNEY STONE, HIGH BLOOD PRESSURE, RELATED TO NERVOUS CONDITIONS***"
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1454-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"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***"
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1455-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***DEVIL HORSEWHIP***1 oz.***USES: COUGH, COLD, CHEST PAIN,***FEVER, VENEREAL DISEASE***"
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1456-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***MANGO LEAF***1 oz.***USES: KIDNEY STONES, HIGH BLOOD PRESSURE, RELATED TO NERVOUS CONDITIONS***"
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1457-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"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
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1458-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"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.
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1459-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***MARSH MARIGOLD***1 oz.***USES: LIVER AILMENTS, HEPATITIS***"; packaged in clear plastic zip-top bags.
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1460-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"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
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1461-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***DOG BLOOD***1 oz.***USES: FIBROIDS, CYST, CLEANS WOMB, WOMAN IMBALANCE, PREVENT MISCARRIAGE***"; packaged in clear plastic zip-top bag
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1462-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"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
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1463-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BLACK WISS***1 oz.***USES: REGULATES GLANDS, CLEANS JOINTS, INFLAMMATION, SUPPLIES ENERGY***"; packaged in clear plastic zip-top bags
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1464-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"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
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1465-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***African Fever Bush***1oz***USES: FEVER, WORMS IN CHILDREN
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1466-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***MOJO BUSH***1 oz.***USES: SKIN, BLOOD PURIFIER, STOMACH & INTESTINAL CLEANSER, REMOVES PARASITES***"; packaged in clear plastic zip-top bags
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1467-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BLOOD LEAF***1oz.***USES: SUPPLIES IRON, FOOD SUPPLEMENT***ANEMIA***"; packaged in clear plastic zip-top bags
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1468-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"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
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1469-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***JAMAICAN MILK WISS***2oz.***USES: REMOVES MUCOUS FROM THE BODY, TUMORS***"; packaged in clear plastic zip-top bags
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1470-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***SPANISH NEEDLE***1oz.***USES: HEART AILMENTS, DIABETES, LOWERS FEVER***"; packaged in clear plastic zip-top bags
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1471-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"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
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1472-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BLUE VERVAIN***1oz.***USES:FEMALE PROBLEMS, WORMS & PARASITES***"; packaged in clear plastic zip-top bags
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1473-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***PIMENTO***1 oz.***USES: STIMULANT, DIABETES, WORMS, PREVENTS STROKES, REDUCES TOBACCO URGE, WARMS BODY***"; packaged in clear plastic zip-top bags
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1474-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"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
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1475-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"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
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1476-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"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
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1477-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***QUASSIA WOOD***2 oz.***USES: ALCOHOLISM, LIVER, STOMACH COMPLAINTS, DIGESTIVE SYSTEM, KILLS LICE & PARASITES***"; packaged in clear plastic zip-top bags
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1478-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"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
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1479-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***WHITE JOINTA***1 oz.***USES: NERVES, COLD, ASTHMA, BRONCHITIS, MUCOUS FEVER MENSTRUAL PROBLEMS***"; packaged in clear plastic zip-top bags
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1480-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"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
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1481-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"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
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1482-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***GUAVA LEAF***1oz.***USES: BLOOD PRESSURE, WORMS, NERVES, DIABETES***"; packaged in clear plastic zip-top bags
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1483-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"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
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1484-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***KING OF THE FOREST***1 oz.***USES: HYPERTENSION, ASTHMA, THROAT, KIDNEY, LIVER SPOTS, HERPES RASHES***"; packaged in clear plastic zip-top bags
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1485-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"***PALO DE BRAZIL***BRASIL WOOD***great to reduce the sugar in the blood and removes gall stone from the kidneys***INSTRUCTIONS. put the wood in pure water and keep in the refrigerator then drink when thirsty***"
Source: FDA Enforcement Reports