Class IITerminated · reported 2020-09-09

Jamaican Bissy Powder; "***Bissy regulates the heart, removes and prevents water from…

Sundial Herbal Products recalled this product and the FDA reported the enforcement action on 9 September 2020 as Class II. The recall was mandated. Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

The record

Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.

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 one to do heavy work without getting tired. The tea also relieves depression, headaches, diarrhea, and dysentery. It's used as antibiotic and antidote***Always have Sundial Bissy and Sundial Ethiopian mitmita (Cayenne pepper) for all medical emergencies***"
Reason for recall: Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
Recalling firm: Sundial Herbal Products
Firm location: Bronx, New York, United States
Classification: Class II
Status: Terminated
Recall number: F-1446-2020
Quantity: Unknown
Distribution: NY
Initiated: 30 June 2020
Reported by FDA: 9 September 2020
Terminated: 26 October 2022
Firm notified by: Letter
Product codes: Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.

Reading this record

Five things about this record are not in the record itself, and each one changes how it should be read.

Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
This recall was not recorded as firm-initiated. The circumstances in which the FDA requests a recall are set out in 21 CFR 7.45.
This is one of 68 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 68 separate recalls, which almost every published figure does, overstates it by a factor of 68. All 68 of them are listed on this page.
The recall ran for 2.3 years, from 30 June 2020 to termination on 26 October 2022. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
The distribution pattern names 1 state, and the FDA published the enforcement report 2 months after the firm began the recall.
Recalls of a spice or seasoning run a median of 6 months, so this one was longer than usual for its category. Spices are a low-moisture, globally sourced, minimally processed ingredient that is added after any kill step, which is the combination that makes Salmonella in a spice lot capable of contaminating every product it was blended into.

What this recall was for

Unapproved ingredients

An unapproved ingredient recall means a product contained a substance not permitted in food, most often an undisclosed pharmaceutical active found in a dietary supplement.

A preventive controls plan covers an unapproved ingredient under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.

21 CFR 111: Dietary supplement CGMP: the identity, purity, strength and composition specifications a supplement manufacturer sets and verifies for every component and finished batch.
21 CFR 117 subpart G: Supply-chain programme: the approval and verification a receiving facility runs on a supplier when the hazard is controlled before the ingredient arrives.

Filed under spices and seasonings and beverages and juice. A product can sit in more than one.

Every product in this recall

The FDA opened 68 enforcement records for this one recall, one per product code. This page carries all of them; the 67 below each have their own page with that product’s lot codes and distribution, and search engines are pointed here for the recall as a whole.

The other 67 records of FDA event 85882
Reported	Product	Firm	Reason	Class
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSWHITE JOINTA1 oz.USES: NERVES, COLD, ASTHMA, BRONCHITIS, MUCOUS FEVER MENSTRUAL PROBLEMS*"; packaged in clear plastic zip-top bags	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	SUNDIAL NIGERIAN MORINGA LEAF POWDER; "*Anti-inflammatory, builds Red Blood cells*" 4oz and 8oz jars	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSDOG BLOOD1 oz.USES: FIBROIDS, CYST, CLEANS WOMB, WOMAN IMBALANCE, PREVENT MISCARRIAGE*"; packaged in clear plastic zip-top bag	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSWHITE SAGE2 oz.USES: EXCESS SWEATING, FEMALE HORMONE, SINUS INFECTION, INDIGESTION, KILLS BACTERIA*"; packaged in clear plastic zip-top bags	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSBREAD NUT1oz.USES: CHOLESTEROL, OMEGA 3, BI POLAR, ANTIOXIDANT, BUILDS BONES, ACNE*"	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*TRADITIONAL HERBAL FORMULAFlu-Allergies HayFever**" packaged in boxes	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSQUASSIA WOOD2 oz.USES: ALCOHOLISM, LIVER, STOMACH COMPLAINTS, DIGESTIVE SYSTEM, KILLS LICE & PARASITES*"; packaged in clear plastic zip-top bags	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSCINNAMON1 oz.USES: STOMACH PAIN, MUCOUS CONGESTION, COLDS, NOSE BLEED, STIMULANT, FLAVORING*"; packaged in clear plastic zip-top bags	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*TRADITIONAL HERBAL FORMULABLOOD PRESSURE**" packaged in boxes	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*TRADITIONAL HERBAL FORMULAHEART**" packaged in boxes	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSBITTER WOOD2 oz.USES: EXPELS WORMS IN THE WEST INTESTINES, DESTROYS PARASITES, LEUKEMIA, DESTROY APPETITE FOR ALCOHOL*"	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	Ghanian Black Spice; "*USES:DYSENTERY, DIARRHEA, RHEUMATISM, FACILITATES CHILDBIRTH**"	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSMOJO BUSH1 oz.USES: SKIN, BLOOD PURIFIER, STOMACH & INTESTINAL CLEANSER, REMOVES PARASITES*"; packaged in clear plastic zip-top bags	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"*PALO DE BRAZILBRASIL WOODgreat to reduce the sugar in the blood and removes gall stone from the kidneysINSTRUCTIONS. put the wood in pure water and keep in the refrigerator then drink when thirsty**"	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSKING OF THE FOREST1 oz.USES: HYPERTENSION, ASTHMA, THROAT, KIDNEY, LIVER SPOTS, HERPES RASHES*"; packaged in clear plastic zip-top bags	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSJACK IN THE BUSH1oz.USES: COLD MEDICINE (ESP. IN CHILDREN), CALMS THE NERVES, RELIEVES DEPRESSION*"; packaged in clear plastic zip-top bags	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSPURPLE SAGE1 oz.USES: DEPRESSION, INSECT BITES, INSOMNIA, RELIEVES CONGESTION*"; packaged in clear plastic zip-top bags	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSFIG LEAF1oz.USES: FIBER, CALCIUM, DIABETES, HIGH BLOOD PRESSURE, GENITAL WARTS, LIVER, ULCERS*"; packaged in clear zip-top bags	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*ETHIOPIAN ABISH (FENNUGREEK SEED POWDER.)*"	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*TRADITIONAL HERBAL FORMULAARTHRITIS**" packaged in boxes	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSRED WATER GRASS1 oz.USES: FEMALE PROBLEMS, FIBROIDS, INFERTILITY, HIGH BLOOD PRESSURE*" packaged in clear plastic zip-top bags	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSTRUMPET LEAF1 oz.USES: DIABETES, ASTHMA, CONGESTION, SKIN BATH, ULCERS, SORES, PARKINSON'S DISEASE, KIDNEY*"; packaged in clear plastic zip-top bags	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*CASSAVA MEAL*" packaged in brown bags with a clear viewing window	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	SUNDIAL Traditional Herbal Products*Mahogany Bark 2 oz.USES: BODY WEAKNESSES, MALE REPRODUCTIVE ORGANS, INFERTILITY*" packaged in zip-top plastic bag	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSGUINEA HEN WEED1 oz.USES: ARTHRITIS, RHEUMATISM, STIMULATE IMMUNE SYSTEM, FIGHTS CANCER CELLS, VIRUSES, YEAST*"; packaged in clear plastic zip-top bags	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSMANGO BARK2 oz.USES: KIDNEY STONE, HIGH BLOOD PRESSURE, RELATED TO NERVOUS CONDITIONS*"	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSBLUE VERVAIN1oz.USES:FEMALE PROBLEMS, WORMS & PARASITES*"; packaged in clear plastic zip-top bags	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSSPANISH NEEDLE1oz.USES: HEART AILMENTS, DIABETES, LOWERS FEVER*"; packaged in clear plastic zip-top bags	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*TRADITIONAL HERBAL FORMULADIABETICS**" packaged in boxes	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSMARSH MARIGOLD1 oz.USES: LIVER AILMENTS, HEPATITIS*"; packaged in clear plastic zip-top bags.	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSAfrican Fever Bush1oz**USES: FEVER, WORMS IN CHILDREN	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*TRADITIONAL AFRICAN MANBACK TONICremember 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	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Hemp Seed Oil*"	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSBLACK WISS1 oz.USES: REGULATES GLANDS, CLEANS JOINTS, INFLAMMATION, SUPPLIES ENERGY*"; packaged in clear plastic zip-top bags	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSFEVER GRASS1oz.USES: FEVER, COLD, MALARIA, FLU, COUGH, PNEUMONIA, HEADACHE, NERVES, STOMACH & BOWEL*"; packaged in clear plastic zip-top bags	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSGUAVA LEAF1oz.USES: BLOOD PRESSURE, WORMS, NERVES, DIABETES*"; packaged in clear plastic zip-top bags	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSBAY LEAVES1 oz.USES: COUGH, COLD, DIABETES, ACHES, PAINS, DIGESTION, FEVER, FLU SYMPTOMS*"; packaged in clear plastic zip-top bags	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*TRADITIONAL HERBAL FORMULAASTHMA**" packaged in boxes	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"AXUM ETHOIPIAN HONEY BEVERAGE*SUNDIAL HERBS*"	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSBLOOD LEAF1oz.USES: SUPPLIES IRON, FOOD SUPPLEMENTANEMIA**"; packaged in clear plastic zip-top bags	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"Sundial*Traditional JamaicanORGANICOriginal Maroon RecipeWOOD AND ROOT TONICused 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 epidemicsINGREDIENTS: Purified, Filtered & Distilled Water Chaney Root, Sarsparilla Root, Black Wis, Milk Wiss, African Cayenne, Sour Sop Leaf, Mango Leaf, Cloves, Pimento, Cinnamon*" packaged in 16oz bottles	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSBROOM WEED1oz.USES: BREAKS UP INFECTION IN BLADDER & REPRODUCTIVE SYTSEM, VENEREAL DISEASE, FEVER*"; packaged in clear plastic zip-top bags	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	Bitter Kola (Arogbo); "*a Natural Antibiotic kills all bacteria, virus, Infections and prevent themit'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 themstrengthen immune system with HIV AIDS*"	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	SUNDIAL (4 oz.) ETHIOPIAN TENADAM HERB; "*Strengthens the Vein & Capillarieslowers high Blood pressure, regulate Heartbeat.heals Stomach ulcers*"	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Talibah's Tooth Powder*"	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSJAMAICAN MILK WISS2oz.USES: REMOVES MUCOUS FROM THE BODY, TUMORS*"; packaged in clear plastic zip-top bags	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Ethiopian Traditional Talba (Flaxseed Meal Cereal)*"	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	Ethiopian Coffee	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSSARSAPARILLA2 oz.USES: BLOOD CLEANSER, BALANCES HORMONES, PRODUCTIVE ORGANS, SYPHILIS, ECZEMA, PSORIASIS*"; packaged in clear plastic zip-top bags.	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL Traditional Herbal Products*TRADITIONAL ORGANIC HERBSCERASEE1 oz.*USES: DIABETES, HYPERTENSION, WORMS, DYSENTERY, MALARIA, BLOOD PURIFIER"; packaged in clear zip-top bags	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*TRADITIONAL HERBAL FORMULAWorms & Parasites**" packaged in boxes	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"*SundialASHANTIWEIGHT LOSS ENERGY LIFTER and APPETITE SUPPRESSER**" packaged in glass bottles	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*COCOA BALLS*" packaged in translucent plastic bags	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSBLACK SAGE1 oz.USES: ALZHEIMER'S DISEASE, GINGIVITIS, MENOPAUSE, APPLY DIRECTLY TO SKIN FOR COLD SORES, ASTHMA*"; packaged in clear plastic zip-top bags	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	SUNDIAL Traditional Herbal Products*TRADITIONAL ORGANIC HERBSCHANEY ROOT2oz.*USES: BLOOD CLEANSER, SKIN PROBLEMS, SYPHILIS, RHEUMATISM, ARTHRITIS	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSDEVIL HORSEWHIP1 oz.USES: COUGH, COLD, CHEST PAIN,FEVER, VENEREAL DISEASE**"	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSPISS A BED1 oz.USES: LIVER TONIC, ARTHRITIS, RHEUMATISM, KIDNEY, BLADDER, JAUNDICE*"; packaged in clear plastic zip-top bags	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSWHITE POND LILY1oz.USES: CANCER, DOUCHE, TUBERCULOSIS IN LYMPH GLANDS, GONORRHEA, ULCER IN MOUTH & THROAT*"; packaged in clear plastic zip-top bags	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	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***"	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSPIMENTO1 oz.USES: STIMULANT, DIABETES, WORMS, PREVENTS STROKES, REDUCES TOBACCO URGE, WARMS BODY*"; packaged in clear plastic zip-top bags	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSMANGO LEAF1 oz.USES: KIDNEY STONES, HIGH BLOOD PRESSURE, RELATED TO NERVOUS CONDITIONS*"	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	SUNDIAL PRINCESS ALMAZ Traditional ETHIOPIAN Organic SPICED TEA; "*Improves circulationeliminates 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.	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSEA MOSS/IRISH MOSS2oz.USES: IODINE, BREAKS UP FAT & MUCOUS, ADD, ULCERS, CALCIUM, THYROID, DETOX*"; packaged in clear plastic zip-top bags	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	SUNDIAL ORGANIC JAMAICAN TUMERIC; "*increases the quality and quantity of breast milksuppresses the development of parasite that causes tumors cancer, growths, cysts & all types of cancers**"	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*KOROMANTEEColonic & Intestinal Cleanerused 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	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Jamaican & Tropical Raw Honey*"	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	ETHIOPIAN FLAX SEED OIL & HONEY BLEND; "*clears bladder, kidney, urinary tract prostate womb and colon, sooths stomach, lowers cholesterol and blood pressureDIST. BY: SUNDIAL HERBAL PRODUCTS**"	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II

Other spices and seasonings recalls for the same reason

These are the closest records in the corpus: the same kind of food, recalled for a hazard this record also names. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.

Reported	Product	Firm	Reason	Class
2026-04-01	Tops GOLD Stuffed Red Chilli Pickle NET QTY.: 31.74oz PRODUCT OF INDIA UPC: 8904288611953 INGREDIENTS:*Mustard Oil*	Mangalm LLC	Potential adulteration with erucic acid from mustard oil ingredient.	Class II
2026-04-01	Tops GOLD Green Chilli Pickle NET QTY.: 31.74oz PRODUCT OF INDIA UPC: 8904288612837 INGREDIENTS:*Mustard Oil*	Mangalm LLC	Potential adulteration with erucic acid from mustard oil ingredient.	Class II
2025-03-19	Trader Joe's branded Solid White Albacore Tuna in Water, no salt added; NET WT. 5 OZ (142g) DR WT. 4 OZ (113g); Dist & Sold Exclusively By: Trader Joe's, Monrovia, CA 91816; UPC# 0099 2848	Chicken of the Sea; Thai Union	Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.	Class II
2025-03-19	Genova branded Yellowfin Tuna in Extra Virgin Olive Oil and Sea Salt; NET WT. 5 OZ (142g) RD WT. 4 OZ (113g); Distributed by Tri-Union Seafoods, LLC.; El Sugundo, CA 90245 U.S.A. UPC# 48000 13275	Chicken of the Sea; Thai Union	Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.	Class II
2025-03-19	Trader Joe's branded Solid White Albacore Tuna in Water, salt added; NET WT. 5 OZ (142g) DR WT. 4 OZ (113g); Dist & Sold Exclusively By: Trader Joe's, Monrovia, CA 91816; UPC# 0099285	Chicken of the Sea; Thai Union	Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.	Class II
2022-05-18	'KORICA' ROASTED PEANUT; 10.6OZ (300G); packaged in plastic bags; Ingredients: Peanuts, Salt, Licorice, Anise, Cinnamon, Food Additives (Cyclamate); Product of P.R.C.; Manufacturer: Jianmen Xinhui Green Day Food Co. Ltd.; RONG SHING TRADING NY INC. 47-57 BRIDGEWATER STREET BROOKLYN NY 11222	Rong Shing Trading NY Inc	Product contains cyclamate, an unapproved color.	Class III
2022-03-23	Port City Soups Thai Green Curry 32oz glass mason jar sold by individual unit	Tony's Tejas Salsa	Production Process not approved for acidified foods.	Class II
2022-01-26	Curry Leaf Hot Pickle packaged in white plastic pouch, net wt. 1/2 KG (500 gms). No UPC. Labeled with Aroma Meats name but has no address.	Aroma Meats LLC	Product was from unapproved source.	Class II

Other records from Sundial Herbal Products

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 67 other records name this firm.

Reported	Product	Firm	Reason	Class
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSWHITE JOINTA1 oz.USES: NERVES, COLD, ASTHMA, BRONCHITIS, MUCOUS FEVER MENSTRUAL PROBLEMS*"; packaged in clear plastic zip-top bags	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	SUNDIAL NIGERIAN MORINGA LEAF POWDER; "*Anti-inflammatory, builds Red Blood cells*" 4oz and 8oz jars	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSDOG BLOOD1 oz.USES: FIBROIDS, CYST, CLEANS WOMB, WOMAN IMBALANCE, PREVENT MISCARRIAGE*"; packaged in clear plastic zip-top bag	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSWHITE SAGE2 oz.USES: EXCESS SWEATING, FEMALE HORMONE, SINUS INFECTION, INDIGESTION, KILLS BACTERIA*"; packaged in clear plastic zip-top bags	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSBREAD NUT1oz.USES: CHOLESTEROL, OMEGA 3, BI POLAR, ANTIOXIDANT, BUILDS BONES, ACNE*"	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*TRADITIONAL HERBAL FORMULAFlu-Allergies HayFever**" packaged in boxes	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSQUASSIA WOOD2 oz.USES: ALCOHOLISM, LIVER, STOMACH COMPLAINTS, DIGESTIVE SYSTEM, KILLS LICE & PARASITES*"; packaged in clear plastic zip-top bags	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSCINNAMON1 oz.USES: STOMACH PAIN, MUCOUS CONGESTION, COLDS, NOSE BLEED, STIMULANT, FLAVORING*"; packaged in clear plastic zip-top bags	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*TRADITIONAL HERBAL FORMULABLOOD PRESSURE**" packaged in boxes	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*TRADITIONAL HERBAL FORMULAHEART**" packaged in boxes	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II

All 68 records for Sundial Herbal Products

All 2020 recalls · All FDA food recall data

21 CFR 111 is the clause behind this recall, and it is one somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.

Early access

Recall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.