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Sundial Herbal Products

68 recall records on file.

2020

20 records

Class IITerminatedRecall F-1440-2020

Product description

SUNDIAL (4 oz.) ETHIOPIAN TENADAM HERB; "***Strengthens the Vein & Capillaries***lowers high Blood pressure, regulate Heartbeat.***heals Stomach ulcers***"

Reason for recall

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

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Event ID
85882
Code info
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Product quantity
Unknown
Distribution pattern
NY
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
3609 Boston Rd, N/A, Bronx, NY, United States
Recall initiation date
06/30/2020
Center classification date
09/15/2020
Termination date
10/26/2022
Class IITerminatedRecall F-1441-2020

Product description

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.

Reason for recall

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

View full record
Event ID
85882
Code info
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Product quantity
Unknown
Distribution pattern
NY
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
3609 Boston Rd, N/A, Bronx, NY, United States
Recall initiation date
06/30/2020
Center classification date
09/15/2020
Termination date
10/26/2022
Class IITerminatedRecall F-1442-2020

Product description

SUNDIAL NIGERIAN MORINGA LEAF POWDER; "***Anti-inflammatory, builds Red Blood cells***" 4oz and 8oz jars

Reason for recall

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

View full record
Event ID
85882
Code info
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Product quantity
Unknown
Distribution pattern
NY
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
3609 Boston Rd, N/A, Bronx, NY, United States
Recall initiation date
06/30/2020
Center classification date
09/15/2020
Termination date
10/26/2022
Class IITerminatedRecall F-1443-2020

Product description

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***"

Reason for recall

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

View full record
Event ID
85882
Code info
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Product quantity
Unknown
Distribution pattern
NY
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
3609 Boston Rd, N/A, Bronx, NY, United States
Recall initiation date
06/30/2020
Center classification date
09/15/2020
Termination date
10/26/2022
Class IITerminatedRecall F-1444-2020

Product description

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***"

Reason for recall

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

View full record
Event ID
85882
Code info
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Product quantity
Unknown
Distribution pattern
NY
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
3609 Boston Rd, N/A, Bronx, NY, United States
Recall initiation date
06/30/2020
Center classification date
09/15/2020
Termination date
10/26/2022
Class IITerminatedRecall F-1445-2020

Product description

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***"

Reason for recall

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

View full record
Event ID
85882
Code info
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Product quantity
Unknown
Distribution pattern
NY
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
3609 Boston Rd, N/A, Bronx, NY, United States
Recall initiation date
06/30/2020
Center classification date
09/15/2020
Termination date
10/26/2022
Class IITerminatedRecall F-1446-2020

Product description

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.

View full record
Event ID
85882
Code info
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Product quantity
Unknown
Distribution pattern
NY
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
3609 Boston Rd, N/A, Bronx, NY, United States
Recall initiation date
06/30/2020
Center classification date
09/15/2020
Termination date
10/26/2022
Class IITerminatedRecall F-1447-2020

Product description

Ghanian Black Spice; "***USES:***DYSENTERY, DIARRHEA, RHEUMATISM, FACILITATES CHILDBIRTH***"

Reason for recall

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

View full record
Event ID
85882
Code info
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Product quantity
Unknown
Distribution pattern
NY
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
3609 Boston Rd, N/A, Bronx, NY, United States
Recall initiation date
06/30/2020
Center classification date
09/15/2020
Termination date
10/26/2022
Class IITerminatedRecall F-1448-2020

Product description

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***"

Reason for recall

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

View full record
Event ID
85882
Code info
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Product quantity
Unknown
Distribution pattern
NY
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
3609 Boston Rd, N/A, Bronx, NY, United States
Recall initiation date
06/30/2020
Center classification date
09/15/2020
Termination date
10/26/2022
Class IITerminatedRecall F-1449-2020

Product description

SUNDIAL Traditional Herbal Products***Mahogany Bark ***2 oz.***USES: BODY WEAKNESSES, MALE REPRODUCTIVE ORGANS, INFERTILITY***" packaged in zip-top plastic bag

Reason for recall

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

View full record
Event ID
85882
Code info
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Product quantity
Unknown
Distribution pattern
NY
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
3609 Boston Rd, N/A, Bronx, NY, United States
Recall initiation date
06/30/2020
Center classification date
09/15/2020
Termination date
10/26/2022
Class IITerminatedRecall F-1450-2020

Product description

SUNDIAL Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***CHANEY ROOT***2oz.***USES: BLOOD CLEANSER, SKIN PROBLEMS, SYPHILIS, RHEUMATISM, ARTHRITIS

Reason for recall

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

View full record
Event ID
85882
Code info
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Product quantity
Unknown
Distribution pattern
NY
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
3609 Boston Rd, N/A, Bronx, NY, United States
Recall initiation date
06/30/2020
Center classification date
09/15/2020
Termination date
10/26/2022
Class IITerminatedRecall F-1451-2020

Product description

"SUNDIAL Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***CERASEE***1 oz.***USES: DIABETES, HYPERTENSION, WORMS, DYSENTERY, MALARIA, BLOOD PURIFIER"; packaged in clear zip-top bags

Reason for recall

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

View full record
Event ID
85882
Code info
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Product quantity
Unknown
Distribution pattern
NY
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
3609 Boston Rd, N/A, Bronx, NY, United States
Recall initiation date
06/30/2020
Center classification date
09/15/2020
Termination date
10/26/2022
Class IITerminatedRecall F-1452-2020

Product description

"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

Reason for recall

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

View full record
Event ID
85882
Code info
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Product quantity
Unknown
Distribution pattern
NY
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
3609 Boston Rd, N/A, Bronx, NY, United States
Recall initiation date
06/30/2020
Center classification date
09/15/2020
Termination date
10/26/2022
Class IITerminatedRecall F-1453-2020

Product description

"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***MANGO BARK***2 oz.***USES: KIDNEY STONE, HIGH BLOOD PRESSURE, RELATED TO NERVOUS CONDITIONS***"

Reason for recall

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

View full record
Event ID
85882
Code info
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Product quantity
Unknown
Distribution pattern
NY
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
3609 Boston Rd, N/A, Bronx, NY, United States
Recall initiation date
06/30/2020
Center classification date
09/15/2020
Termination date
10/26/2022
Class IITerminatedRecall F-1454-2020

Product description

"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***"

Reason for recall

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

View full record
Event ID
85882
Code info
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Product quantity
Unknown
Distribution pattern
NY
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
3609 Boston Rd, N/A, Bronx, NY, United States
Recall initiation date
06/30/2020
Center classification date
09/15/2020
Termination date
10/26/2022
Class IITerminatedRecall F-1455-2020

Product description

"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***DEVIL HORSEWHIP***1 oz.***USES: COUGH, COLD, CHEST PAIN,***FEVER, VENEREAL DISEASE***"

Reason for recall

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

View full record
Event ID
85882
Code info
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Product quantity
Unknown
Distribution pattern
NY
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
3609 Boston Rd, N/A, Bronx, NY, United States
Recall initiation date
06/30/2020
Center classification date
09/15/2020
Termination date
10/26/2022
Class IITerminatedRecall F-1456-2020

Product description

"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***MANGO LEAF***1 oz.***USES: KIDNEY STONES, HIGH BLOOD PRESSURE, RELATED TO NERVOUS CONDITIONS***"

Reason for recall

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

View full record
Event ID
85882
Code info
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Product quantity
Unknown
Distribution pattern
NY
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
3609 Boston Rd, N/A, Bronx, NY, United States
Recall initiation date
06/30/2020
Center classification date
09/15/2020
Termination date
10/26/2022
Class IITerminatedRecall F-1457-2020

Product description

"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

Reason for recall

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

View full record
Event ID
85882
Code info
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Product quantity
Unknown
Distribution pattern
NY
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
3609 Boston Rd, N/A, Bronx, NY, United States
Recall initiation date
06/30/2020
Center classification date
09/15/2020
Termination date
10/26/2022
Class IITerminatedRecall F-1458-2020

Product description

"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.

Reason for recall

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

View full record
Event ID
85882
Code info
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Product quantity
Unknown
Distribution pattern
NY
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
3609 Boston Rd, N/A, Bronx, NY, United States
Recall initiation date
06/30/2020
Center classification date
09/15/2020
Termination date
10/26/2022
Class IITerminatedRecall F-1459-2020

Product description

"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***MARSH MARIGOLD***1 oz.***USES: LIVER AILMENTS, HEPATITIS***"; packaged in clear plastic zip-top bags.

Reason for recall

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

View full record
Event ID
85882
Code info
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Product quantity
Unknown
Distribution pattern
NY
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
3609 Boston Rd, N/A, Bronx, NY, United States
Recall initiation date
06/30/2020
Center classification date
09/15/2020
Termination date
10/26/2022