Unauthorised substance or claim: food recalls in the United States · page 3
603 official food recall notices published by the U.S. Food and Drug Administration (FDA) in the United States for the reason “Unauthorised substance or claim” (Shelfpedia classification of the official reason), newest first. Each notice links to the official page.
Notices
603 notices, newest first · page 3 of 13.
- September 9, 2020reportedFDAClass IIUnauthorised substance or claim
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***KING OF THE FOREST***1 oz.***USES: HYPERTENSION, ASTHMA, THROAT, KIDNEY, LIVER SPOTS…
Official wording (English):
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
- September 9, 2020reportedFDAClass IIUnauthorised substance or claim
"***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…
Official wording (English):
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
- September 9, 2020reportedFDAClass IIUnauthorised substance or claim
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BROOM WEED***1oz.***USES: BREAKS UP INFECTION IN BLADDER & REPRODUCTIVE SYTSEM, VENEREAL…
Official wording (English):
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
- September 9, 2020reportedFDAClass IIUnauthorised substance or claim
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BREAD NUT***1oz.***USES: CHOLESTEROL, OMEGA 3, BI POLAR, ANTIOXIDANT, BUILDS BONES…
Official wording (English):
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
- September 9, 2020reportedFDAClass IIUnauthorised substance or claim
"Sundial***Traditional Jamaican***ORGANIC***Original Maroon Recipe***WOOD AND ROOT TONIC***used for centuries in Jamaica as a household remedy, to cleanse the…
Official wording (English):
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
- September 9, 2020reportedFDAClass IIUnauthorised substance or claim
"SUNDIAL***KOROMANTEE***Colonic & Intestinal Cleaner***used by the descendants of the Koromantee people in Jamaica to help cleanse and strengthen the bowels…
Official wording (English):
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
- September 9, 2020reportedFDAClass IIUnauthorised substance or claim
"***Sundial***ASHANTI**WEIGHT LOSS ENERGY LIFTER and APPETITE SUPPRESSER***" packaged in glass bottles
Official wording (English):
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
- September 9, 2020reportedFDAClass IIUnauthorised substance or claim
"SUNDIAL***TRADITIONAL AFRICAN MANBACK TONIC***remember the strength of the reproductive organ, reflects the strength of the entire body. Take SUNDIAL AFRICAN…
Official wording (English):
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
- September 9, 2020reportedFDAClass IIUnauthorised substance or claim
"SUNDIAL***TRADITIONAL HERBAL FORMULA***DIABETICS***" packaged in boxes
Official wording (English):
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
- September 9, 2020reportedFDAClass IIUnauthorised substance or claim
"SUNDIAL***TRADITIONAL HERBAL FORMULA***ASTHMA***" packaged in boxes
Official wording (English):
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
- September 9, 2020reportedFDAClass IIUnauthorised substance or claim
"SUNDIAL***TRADITIONAL HERBAL FORMULA***BLOOD PRESSURE***" packaged in boxes
Official wording (English):
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
- September 9, 2020reportedFDAClass IIUnauthorised substance or claim
"SUNDIAL***TRADITIONAL HERBAL FORMULA***HEART***" packaged in boxes
Official wording (English):
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
- September 9, 2020reportedFDAClass IIUnauthorised substance or claim
"SUNDIAL***TRADITIONAL HERBAL FORMULA***Worms & Parasites***" packaged in boxes
Official wording (English):
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
- September 9, 2020reportedFDAClass IIUnauthorised substance or claim
"SUNDIAL***TRADITIONAL HERBAL FORMULA***Flu-Allergies HayFever***" packaged in boxes
Official wording (English):
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
- September 9, 2020reportedFDAClass IIUnauthorised substance or claim
"SUNDIAL***TRADITIONAL HERBAL FORMULA***ARTHRITIS***" packaged in boxes
Official wording (English):
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
- September 9, 2020reportedFDAClass IIUnauthorised substance or claim
"AXUM ETHOIPIAN HONEY BEVERAGE***SUNDIAL HERBS***"
Official wording (English):
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
- September 9, 2020reportedFDAClass IIUnauthorised substance or claim
"SUNDIAL***CASSAVA MEAL***" packaged in brown bags with a clear viewing window
Official wording (English):
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
- September 9, 2020reportedFDAClass IIUnauthorised substance or claim
"SUNDIAL***COCOA BALLS***" packaged in translucent plastic bags
Official wording (English):
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
- September 9, 2020reportedFDAClass IIUnauthorised substance or claim
"SUNDIAL***ETHIOPIAN ABISH (FENNUGREEK SEED POWDER.)***"
Official wording (English):
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
- September 9, 2020reportedFDAClass IIUnauthorised substance or claim
"SUNDIAL***Ethiopian Traditional Talba (Flaxseed Meal Cereal)***"
Official wording (English):
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
- September 9, 2020reportedFDAClass IIUnauthorised substance or claim
"SUNDIAL***Jamaican & Tropical Raw Honey***"
Official wording (English):
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
- September 9, 2020reportedFDAClass IIUnauthorised substance or claim
"SUNDIAL***Hemp Seed Oil***"
Official wording (English):
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
- September 9, 2020reportedFDAClass IIUnauthorised substance or claim
"SUNDIAL***Talibah's Tooth Powder***"
Official wording (English):
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
- September 9, 2020reportedFDAClass IIUnauthorised substance or claim
Ethiopian Coffee
Official wording (English):
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
- July 22, 2020reportedFDAClass IIUnauthorised substance or claim
Anti-Viral Immune Enhance "Corona Virus (COVID-19) " "Influenza (H1N1)" "Bronchitis" "Common Cold" 60 Capsules, Dietary Supplement, Manufactured by: Golden…
Official wording (English):
The product is a dietary supplement with drug claims (COVID-19)
- May 20, 2020reportedFDAClass IIUnauthorised substance or claim
Natural by Nature 1 % Milk (gallon, 1/2 gallon, and quart)
Official wording (English):
A sample of the product was found to be positive with Antibiotic Residue.
- May 20, 2020reportedFDAClass IIUnauthorised substance or claim
Fairway Market 1 % Milk (1/2 gallon and gallon)
Official wording (English):
A sample of the product was found to be positive with Antibiotic Residue.
- May 20, 2020reportedFDAClass IIUnauthorised substance or claim
Common Market 1 % Milk (1/2 Gallon)
Official wording (English):
A sample of the product was found to be positive with Antibiotic Residue.
- February 19, 2020reportedFDAClass IIUnauthorised substance or claim
bliss anti-stress formula Dietary Supplement, 60 Tablets; Manufactured For and distributed by: Market America, Inc., 1302 Pleasant Ridge Road, Greensboro, NC…
Official wording (English):
Potentially undeclared Yohimbe 83 and complaints of adverse reactions: upset stomach, jittery, sweaty, lightheaded or dizzy.
- May 22, 2019reportedFDAClass IIIUnauthorised substance or claim
Item #13898 Raw California Orange Blossom Honey, packaged in an 18 oz jar with gold metal lid. Retail Jar UPC: 0 30042 00305 9. Item #13899 Raw California…
Official wording (English):
Raw California Orange Blossom Honey was recalled due to two random FDA samples tested for unapproved fumagillin (antibiotic drug) residue.
- July 11, 2018reportedFDAClass IIUnauthorised substance or claim
SNI Nitric Blast Sour Apple 276gr (UPC ending in 5581) --- The product is a powder marketed in a 276gr black bottle with a silver cap. The bottle prominently…
Official wording (English):
SNI, LLC is recalling certain Nitric Blast brand products that contain geranium extract as a dietary ingredient. This ingredient is also called, among other names, dimethylamylamine, 1,3-dimethylamylamine, DMAA or methylhexanamine (DMAA ).
- July 11, 2018reportedFDAClass IIUnauthorised substance or claim
SNI Nitric Blast Pink Lemonade 276gr (UPC ending in 5598)
Official wording (English):
SNI, LLC is recalling certain Nitric Blast brand products that contain geranium extract as a dietary ingredient. This ingredient is also called, among other names, dimethylamylamine, 1,3-dimethylamylamine, DMAA or methylhexanamine (DMAA ).
- July 4, 2018reportedFDAClass IIIUnauthorised substance or claim
Belly Fat Reducer + Energy Booster and Stamina, Dietary Supplement
Official wording (English):
The product Blood & Internal Cleanser is a dietary supplement with drug claims and iron content at 67 & 69% of declared, per laboratory results. The product Belly Fat Reducer + Energy Booster and Stamina declares incorrect amount of Vitamin B6. The product label declares 50mg and only contains 0.1…
- July 4, 2018reportedFDAClass IIUnauthorised substance or claim
Blood & Internal Cleanser, Dietary Supplement
Official wording (English):
The product Blood & Internal Cleanser is a dietary supplement with drug claims and iron content at 67 & 69% of declared, per laboratory results. The product Belly Fat Reducer + Energy Booster and Stamina declares incorrect amount of Vitamin B6. The product label declares 50mg and only contains 0.1…
- May 30, 2018reportedFDAClass IIUnauthorised substance or claim
Nature's Only Choice B17 BITTER RAW APRICOT EXTRACT AMYGDALIN Dietary Supplement 100 Capsules
Official wording (English):
The Vitamin B17 containing product is considered to be a prescription drug, new drug, and unapproved new drug.
- May 16, 2018reportedFDAClass IIUnauthorised substance or claim
Peaceful Mountain -Stomach Rescue - Dietary supplement - Elemental silver (45 ppm) 2.7 mg; Dist. by Peaceful Mountain, Inc. Woodbine, IA 51579
Official wording (English):
Multiple products marketed as dietary supplements are unapproved new drugs based on disease claims or routes of administration.
- May 16, 2018reportedFDAClass IIUnauthorised substance or claim
Energique, Herbal Supplement, Octocom,; Dist. by Energique, Inc. Woodbine, IA 51579
Official wording (English):
Multiple products marketed as dietary supplements are unapproved new drugs based on disease claims or routes of administration.
- May 16, 2018reportedFDAClass IIUnauthorised substance or claim
Peaceful Mountain, Nasal Rescue, Dietary Supplement, Natural Sinus Support, Dist. by Peaceful Mountain, Inc. Woodbine, IA 51579
Official wording (English):
Multiple products marketed as dietary supplements are unapproved new drugs based on disease claims or routes of administration.
- May 16, 2018reportedFDAClass IIUnauthorised substance or claim
Energique, Dietary Supplement, Enervimin CNCR Focus, Dist. by Energique Inc.. Woodbine, IA 51579
Official wording (English):
Multiple products marketed as dietary supplements are unapproved new drugs based on disease claims or routes of administration.
- January 10, 2018reportedFDAClass IIUnauthorised substance or claim
Early Dawn; Whole Tilapia IQF, Gutted & Scaled, Farm Raised, 40 lbs.; Size 550-750g OR 750g+, Lot No.: 1985507; Production Date: 08/12/2017; Best Used By Date…
Official wording (English):
Early Dawn Whole Tilapia was sampled and found positive for the antibiotic, Sulfadiazine.
- November 29, 2017reportedFDAClass IIUnauthorised substance or claim
Icybay Brand Frog Legs, 4/6 Ct / Lb Farm Raised Trimmed, Frozen. 30 lb. Master Carton (5 lb. inner boxes 6 boxes per master case) UPC Codes: 073129282770
Official wording (English):
Unapproved antibiotics-Nitrofurans and Chloramphenicol present
- September 20, 2017reportedFDAClass IIUnauthorised substance or claim
Rugby Calcionate Syrup, One Pint (473 mL)
Official wording (English):
The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard Drug Group dba Rugby Laboratories are jointly initiating a voluntary recall of multiple supplements due to possible product contamination with B. cepacia, which may result in serious infections that could be…
- September 20, 2017reportedFDAClass IIUnauthorised substance or claim
Rugby Cerovite Liquid, 8 oz. 236ML
Official wording (English):
The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard Drug Group dba Rugby Laboratories are jointly initiating a voluntary recall of multiple supplements due to possible product contamination with B. cepacia, which may result in serious infections that could be…
- September 20, 2017reportedFDAClass IIUnauthorised substance or claim
Rugby D 3 Vitamin Liquid, 400 IUI/1 mL, 1 and 2/3 oz., 50 mL
Official wording (English):
The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard Drug Group dba Rugby Laboratories are jointly initiating a voluntary recall of multiple supplements due to possible product contamination with B. cepacia, which may result in serious infections that could be…
- September 20, 2017reportedFDAClass IIUnauthorised substance or claim
Rugby Fer-iron Liquid, 1 and 2/3 oz., 50 mL
Official wording (English):
The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard Drug Group dba Rugby Laboratories are jointly initiating a voluntary recall of multiple supplements due to possible product contamination with B. cepacia, which may result in serious infections that could be…
- September 20, 2017reportedFDAClass IIUnauthorised substance or claim
Rugby Liquid Vitamin C Supplement, 4 oz., 118 mL
Official wording (English):
The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard Drug Group dba Rugby Laboratories are jointly initiating a voluntary recall of multiple supplements due to possible product contamination with B. cepacia, which may result in serious infections that could be…
- September 20, 2017reportedFDAClass IIUnauthorised substance or claim
Rugby Ferrous Sulfate Liquid One Pint, (473 mL)
Official wording (English):
The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard Drug Group dba Rugby Laboratories are jointly initiating a voluntary recall of multiple supplements due to possible product contamination with B. cepacia, which may result in serious infections that could be…
- September 20, 2017reportedFDAClass IIUnauthorised substance or claim
Rugby Polyvitamin Liquid, 1 2/3 oz (50 mL)
Official wording (English):
The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard Drug Group dba Rugby Laboratories are jointly initiating a voluntary recall of multiple supplements due to possible product contamination with B. cepacia, which may result in serious infections that could be…
- September 20, 2017reportedFDAClass IIUnauthorised substance or claim
Rugby Polyvitamin Liquid with Iron, 1 2/3 oz (50 mL)
Official wording (English):
The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard Drug Group dba Rugby Laboratories are jointly initiating a voluntary recall of multiple supplements due to possible product contamination with B. cepacia, which may result in serious infections that could be…
- September 20, 2017reportedFDAClass IIUnauthorised substance or claim
Rugby Tri-vitamin Liquid, 1 2/3 oz (50 mL)
Official wording (English):
The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard Drug Group dba Rugby Laboratories are jointly initiating a voluntary recall of multiple supplements due to possible product contamination with B. cepacia, which may result in serious infections that could be…
Sources: openFDA (U.S. FDA food enforcement reports), CC0 · Health Canada / CFIA Recalls and Safety Alerts, Open Government Licence – Canada · Food Standards Agency food alerts, OGL v3 · RappelConso (DGCCRF), Licence Ouverte 2.0. Shares and counts: Shelfpedia calculations.