Food recall: SUNDIAL (4 oz.) ETHIOPIAN TENADAM HERB; "***Strengthens the Vein & Capillaries***lowers high Blood pressure, regulate…
Class II FDA enforcement event 85882. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sundial Herbal Products started this food recall on 30 Jun 2020. The firm address in the FDA record is in Bronx, NY. FDA put the recall in Class II. FDA event 85882 has 68 product records. The first FDA enforcement report date is 9 Sep 2020. The record gives the status Terminated, with the termination date 26 Oct 2022.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
NY
Recalling firm
Sundial Herbal Products, Bronx, NY.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: FDA Mandated.
Products
68 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| F-1440-2020 | SUNDIAL (4 oz.) ETHIOPIAN TENADAM HERB; "***Strengthens the Vein & Capillaries***lowers high Blood pressure, regulate Heartbeat.***heals Stomach ulcers***" | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1441-2020 | 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 in a breathable-type bag within a box. | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1442-2020 | SUNDIAL NIGERIAN MORINGA LEAF POWDER; "***Anti-inflammatory, builds Red Blood cells***" 4oz and 8oz jars | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1443-2020 | 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***" | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1444-2020 | 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***" | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1445-2020 | 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 Bacteria that causes them***strengthen immune system with HIV AIDS***" | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1446-2020 | 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 one to do heavy work without getting… | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1447-2020 | Ghanian Black Spice; "***USES:***DYSENTERY, DIARRHEA, RHEUMATISM, FACILITATES CHILDBIRTH***" | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1448-2020 | 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***" | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1449-2020 | SUNDIAL Traditional Herbal Products***Mahogany Bark ***2 oz.***USES: BODY WEAKNESSES, MALE REPRODUCTIVE ORGANS, INFERTILITY***" packaged in zip-top plastic bag | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1450-2020 | SUNDIAL Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***CHANEY ROOT***2oz.***USES: BLOOD CLEANSER, SKIN PROBLEMS, SYPHILIS, RHEUMATISM, ARTHRITIS | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1451-2020 | "SUNDIAL Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***CERASEE***1 oz.***USES: DIABETES, HYPERTENSION, WORMS, DYSENTERY, MALARIA, BLOOD PURIFIER"; packaged in clear zip-top bags | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1452-2020 | "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 | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1453-2020 | "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***MANGO BARK***2 oz.***USES: KIDNEY STONE, HIGH BLOOD PRESSURE, RELATED TO NERVOUS CONDITIONS***" | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1454-2020 | "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***" | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1455-2020 | "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***DEVIL HORSEWHIP***1 oz.***USES: COUGH, COLD, CHEST PAIN,***FEVER, VENEREAL DISEASE***" | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1456-2020 | "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***MANGO LEAF***1 oz.***USES: KIDNEY STONES, HIGH BLOOD PRESSURE, RELATED TO NERVOUS CONDITIONS***" | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1457-2020 | "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 | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1458-2020 | "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. | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1459-2020 | "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***MARSH MARIGOLD***1 oz.***USES: LIVER AILMENTS, HEPATITIS***"; packaged in clear plastic zip-top bags. | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1460-2020 | "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 | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1461-2020 | "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 | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1462-2020 | "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 | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1463-2020 | "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 | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1464-2020 | "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 | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1465-2020 | "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***African Fever Bush***1oz***USES: FEVER, WORMS IN CHILDREN | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1466-2020 | "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 | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1467-2020 | "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BLOOD LEAF***1oz.***USES: SUPPLIES IRON, FOOD SUPPLEMENT***ANEMIA***"; packaged in clear plastic zip-top bags | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1468-2020 | "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 | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1469-2020 | "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 | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1470-2020 | "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***SPANISH NEEDLE***1oz.***USES: HEART AILMENTS, DIABETES, LOWERS FEVER***"; packaged in clear plastic zip-top bags | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1471-2020 | "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 | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1472-2020 | "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BLUE VERVAIN***1oz.***USES:FEMALE PROBLEMS, WORMS & PARASITES***"; packaged in clear plastic zip-top bags | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1473-2020 | "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 | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1474-2020 | "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 | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1475-2020 | "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 | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1476-2020 | "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 | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1477-2020 | "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 | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1478-2020 | "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 | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1479-2020 | "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 | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1480-2020 | "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 | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1481-2020 | "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 | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1482-2020 | "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***GUAVA LEAF***1oz.***USES: BLOOD PRESSURE, WORMS, NERVES, DIABETES***"; packaged in clear plastic zip-top bags | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1483-2020 | "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 | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1484-2020 | "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 | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1485-2020 | "***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***" | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1486-2020 | "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BROOM WEED***1oz.***USES: BREAKS UP INFECTION IN BLADDER & REPRODUCTIVE SYTSEM, VENEREAL DISEASE, FEVER***"; packaged in clear plastic zip-top bags | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1487-2020 | "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BREAD NUT***1oz.***USES: CHOLESTEROL, OMEGA 3, BI POLAR, ANTIOXIDANT, BUILDS BONES, ACNE***" | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1488-2020 | "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 epidemics***INGREDIENTS: Purified,… | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1489-2020 | "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 | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1490-2020 | "***Sundial***ASHANTI**WEIGHT LOSS ENERGY LIFTER and APPETITE SUPPRESSER***" packaged in glass bottles | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1491-2020 | "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 | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1492-2020 | "SUNDIAL***TRADITIONAL HERBAL FORMULA***DIABETICS***" packaged in boxes | TBD | Class II | Terminated | 9 Sep 2020 |
| F-1493-2020 | "SUNDIAL***TRADITIONAL HERBAL FORMULA***ASTHMA***" packaged in boxes | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1494-2020 | "SUNDIAL***TRADITIONAL HERBAL FORMULA***BLOOD PRESSURE***" packaged in boxes | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1495-2020 | "SUNDIAL***TRADITIONAL HERBAL FORMULA***HEART***" packaged in boxes | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1496-2020 | "SUNDIAL***TRADITIONAL HERBAL FORMULA***Worms & Parasites***" packaged in boxes | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1497-2020 | "SUNDIAL***TRADITIONAL HERBAL FORMULA***Flu-Allergies HayFever***" packaged in boxes | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1498-2020 | "SUNDIAL***TRADITIONAL HERBAL FORMULA***ARTHRITIS***" packaged in boxes | Unknown | Class II | Terminated | 9 Sep 2020 |
| F-1499-2020 | "AXUM ETHOIPIAN HONEY BEVERAGE***SUNDIAL HERBS***" | Unknown | Class II | Terminated | 9 Sep 2020 |
The table shows 60 of 68 product records. The FDA enforcement report lists all the records.
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Food events that started in 2020
- 381
- Share of these events in Class II
- 57%
- Product records in this event
- 68
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report F-1440-2020The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA: report a problemThe FDA page that shows where a report about a product goes.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 85882. https://recallregister.com/fda/ii/85882/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA food enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
NY
- What quantity of product is in FDA event 85882?
- The event has 68 product records. The first record gives this quantity:
Unknown
- How did the recall start?
- The FDA record says:
FDA Mandated
- How many food recalls of 2020 have the same class?
- 57% of the 381 food events that started in 2020 are in Class II.