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

2020-06-30
RecallRecall F-1486-2020 · 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***BROOM WEED***1oz.***USES: BREAKS UP INFECTION IN BLADDER & REPRODUCTIVE SYTSEM, VENEREAL DISEASE, FEVER***"; packaged in clear plastic zip-top bags
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1487-2020 · 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***BREAD NUT***1oz.***USES: CHOLESTEROL, OMEGA 3, BI POLAR, ANTIOXIDANT, BUILDS BONES, ACNE***"
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1488-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"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 Cent…
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1489-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"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 bot…
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1490-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"***Sundial***ASHANTI**WEIGHT LOSS ENERGY LIFTER and APPETITE SUPPRESSER***" packaged in glass bottles
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1491-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"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
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1492-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"SUNDIAL***TRADITIONAL HERBAL FORMULA***DIABETICS***" packaged in boxes
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1493-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"SUNDIAL***TRADITIONAL HERBAL FORMULA***ASTHMA***" packaged in boxes
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1494-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"SUNDIAL***TRADITIONAL HERBAL FORMULA***BLOOD PRESSURE***" packaged in boxes
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1495-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"SUNDIAL***TRADITIONAL HERBAL FORMULA***HEART***" packaged in boxes
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1496-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"SUNDIAL***TRADITIONAL HERBAL FORMULA***Worms & Parasites***" packaged in boxes
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1497-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"SUNDIAL***TRADITIONAL HERBAL FORMULA***Flu-Allergies HayFever***" packaged in boxes
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1498-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"SUNDIAL***TRADITIONAL HERBAL FORMULA***ARTHRITIS***" packaged in boxes
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1499-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"AXUM ETHOIPIAN HONEY BEVERAGE***SUNDIAL HERBS***"
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1500-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"SUNDIAL***CASSAVA MEAL***" packaged in brown bags with a clear viewing window
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1501-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"SUNDIAL***COCOA BALLS***" packaged in translucent plastic bags
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1502-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"SUNDIAL***ETHIOPIAN ABISH (FENNUGREEK SEED POWDER.)***"
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1503-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"SUNDIAL***Ethiopian Traditional Talba (Flaxseed Meal Cereal)***"
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1504-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"SUNDIAL***Jamaican & Tropical Raw Honey***"
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1505-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"SUNDIAL***Hemp Seed Oil***"
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1506-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
"SUNDIAL***Talibah's Tooth Powder***"
Source: FDA Enforcement Reports
2020-06-30
RecallRecall F-1507-2020 · Class 2 · Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
Ethiopian Coffee
Source: FDA Enforcement Reports
2020-05-27
Compliance actionFDA Injunction (CFSAN)
FDA source
2017-02-17
InspectionFDA inspection · Classification: Official Action Indicated (OAI)
Project area: Food Composition, Standards, Labeling and Econ
FDA source
2014-02-12
InspectionFDA inspection · Classification: Voluntary Action Indicated (VAI)
Project area: Foodborne Biological Hazards
FDA source
2014-02-12
InspectionFDA inspection · Classification: Voluntary Action Indicated (VAI)
Project area: Food Composition, Standards, Labeling and Econ
FDA source
2013-05-24
Warning letterFDA Warning Letter (CFSAN)
FDA source
2012-11-15
InspectionFDA inspection · Classification: Official Action Indicated (OAI)
Project area: Foodborne Biological Hazards
FDA source
2012-11-15
InspectionFDA inspection · Classification: Official Action Indicated (OAI)
Project area: Food Composition, Standards, Labeling and Econ
FDA source