The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

6476–6500 of 21595

  • ModerateFDA (Food)·F-1479-2020·2020-09-09

    Sundial White Jointa Herbal Product Recalled for Misbranding

    Sundial Herbal Products is recalling White Jointa herbal products under a permanent injunction because the items are misbranded and deemed unapproved drugs.

    Product
    "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
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1450-2020·2020-09-09

    Sundial Chaney Root Herbal Product Recalled for Unapproved Drug Claims

    Sundial Herbal Products is recalling Chaney Root herbal products under a permanent injunction because the items are misbranded and deemed unapproved drugs.

    Product
    SUNDIAL Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***CHANEY ROOT***2oz.***USES: BLOOD CLEANSER, SKIN PROBLEMS, SYPHILIS, RHEUMATISM, ARTHRITIS
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2923-2020·2020-09-09

    Randox Laboratories Recalls Amylase Reagents Due to Performance Failures

    Randox Laboratories is recalling specific batches of Amylase reagents because they failed to meet performance claims prior to their September 2020 expiry date.

    Product
    Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Food)·F-1496-2020·2020-09-09

    Sundial Herbal Worms and Parasites Formula Recalled as Unapproved Drug

    Sundial Herbal Products is recalling its Traditional Herbal Formula for Worms & Parasites because the product is misbranded and deemed an unapproved drug.

    Product
    "SUNDIAL***TRADITIONAL HERBAL FORMULA***Worms & Parasites***" packaged in boxes
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1501-2020·2020-09-09

    Sundial Herbal Products Recalls Cocoa Balls for Unapproved Drug Claims

    Sundial Herbal Products is recalling Sundial Cocoa Balls because the product is misbranded and deemed an unapproved drug based on labeling claims.

    Product
    "SUNDIAL***COCOA BALLS***" packaged in translucent plastic bags
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1560-2020·2020-09-09

    Bersih Hand Sanitizer Gel Recalled for cGMP Deviations

    Soluciones Cosmeticas, SA de CV is voluntarily recalling Bersih Hand Sanitizer Gel due to cGMP deviations. The product was distributed in the United States.

    Product
    Bersih Hand Sanitizer Gel, Net wt. 16.9 floz (500ml), Blue and Green cap) Distributed by RediBag USA 135 Fulton Ave New Hyde Park, NY 11040 UPC 8 16822 02666 7
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2933-2020·2020-09-09

    Stimwave StimQ Peripheral Nerve Stimulator Recalled for Non-Functional Component

    Stimwave Technologies is recalling 13 StimQ Peripheral Nerve Stimulator units because they contain a non-functional component not listed in the product labeling.

    Product
    StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and 2. FR4A-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrica
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1447-2020·2020-09-09

    Sundial Herbal Products Recalls Ghanian Black Spice for Unapproved Drug Claims

    Sundial Herbal Products is recalling Ghanian Black Spice because the product is misbranded and deemed an unapproved drug due to labeling claims.

    Product
    Ghanian Black Spice; "***USES:***DYSENTERY, DIARRHEA, RHEUMATISM, FACILITATES CHILDBIRTH***"
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1452-2020·2020-09-09

    Sundial Bay Leaves Recalled for Unapproved Drug Claims

    Sundial Herbal Products is recalling bay leaves labeled with unapproved drug claims. The FDA determined the products are misbranded and unapproved drugs.

    Product
    "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
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2931-2020·2020-09-09

    Stimwave StimQ Peripheral Nerve Stimulator System Recalled for Non-Functional Component

    Stimwave Technologies is recalling six StimQ Peripheral Nerve Stimulator Systems because they contain a non-functional component not referenced in product labeling.

    Product
    StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an elec
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1482-2020·2020-09-09

    Sundial Guava Leaf Herbal Product Recalled for Unapproved Drug Claims

    Sundial Herbal Products is recalling Guava Leaf herbal products because they are misbranded and deemed unapproved drugs based on labeling claims.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***GUAVA LEAF***1oz.***USES: BLOOD PRESSURE, WORMS, NERVES, DIABETES***"; packaged in clear plastic zip-top bags
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1364-2020·2020-09-09

    Newman's Own Organic Decaf Coffee Recalled for Containing Non-Organic Beans

    Keurig Dr Pepper is recalling Newman's Own Organic Decaf Ground Coffee because it contains regular non-organic coffee. Consumers should stop using the product.

    Product
    Newman's Own Organics, Newman's Special Decaf Medium Roast, Ground Coffee, 10 oz.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-1489-2020·2020-09-09

    Sundial Herbal Products Recalls Koromantee Colonic Cleaner as Unapproved Drug

    Sundial Herbal Products is recalling Koromantee Colonic & Intestinal Cleaner because the product is misbranded and deemed an unapproved drug based on its labeling claims.

    Product
    "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
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2926-2020·2020-09-09

    Exactech Recalls Vantage Total Ankle Tibial Inserts Due to Labeling Error

    Exactech is recalling 11 Vantage Total Ankle Tibial Inserts because the labels incorrectly identify the implant size as 3 instead of 4.

    Product
    The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2930-2020·2020-09-09

    Stimwave StimQ Peripheral Nerve Stimulator Recalled for Non-Functional Component

    Stimwave Technologies is recalling 1,424 StimQ Peripheral Nerve Stimulator units because they contain a non-functional component not referenced in product labeling.

    Product
    StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical cu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1440-2020·2020-09-09

    FDA Recalls Sundial Ethiopian Tenadam Herb for Unapproved Drug Claims

    Sundial Herbal Products is recalling Sundial Ethiopian Tenadam Herb because the product is misbranded and deemed an unapproved drug based on its labeling claims.

    Product
    SUNDIAL (4 oz.) ETHIOPIAN TENADAM HERB; "***Strengthens the Vein & Capillaries***lowers high Blood pressure, regulate Heartbeat.***heals Stomach ulcers***"
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2936-2020·2020-09-09

    Diasorin Recalls Parvovirus B19 IgG EIA Kit Due to Labeling Error

    Diasorin Inc. is recalling 615 units of the Parvovirus B19 IgG EIA kit because the printed label inside the box lid contains an incorrect Lot Specific Constant value.

    Product
    Parvovirus B19 IgG EIA kit Part No. V519IGUS
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Food)·F-1462-2020·2020-09-09

    Sundial Black Sage Herbal Product Recalled for Unapproved Drug Claims

    Sundial Herbal Products is recalling Black Sage herbal products under a permanent injunction because the labeling makes unapproved drug claims.

    Product
    "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
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1454-2020·2020-09-09

    Sundial Bitter Wood Herbal Product Recalled for Unapproved Drug Claims

    Sundial Herbal Products is recalling Bitter Wood herbal products under a court order because the labels make unapproved drug claims.

    Product
    "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***"
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1448-2020·2020-09-09

    Sundial Herbal Products Recalls Mitmitta Cayenne Pepper Product

    Sundial Herbal Products is recalling Mitmitta (Cayenne Pepper) because it is misbranded and deemed an unapproved drug due to labeling claims.

    Product
    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***"
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1464-2020·2020-09-09

    Sundial Cinnamon Herbal Product Recalled for Misbranding and Unapproved Drug Claims

    Sundial Herbal Products is recalling 1 oz. bags of Cinnamon under a permanent injunction because the product is misbranded and deemed an unapproved drug.

    Product
    "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
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1445-2020·2020-09-09

    FDA Recalls Sundial Herbal Bitter Kola for Unapproved Drug Claims

    Sundial Herbal Products is recalling Bitter Kola (Arogbo) in New York because the product is misbranded and deemed an unapproved drug based on its labeling claims.

    Product
    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 im
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1453-2020·2020-09-09

    Sundial Mango Bark Herbal Product Recalled for Unapproved Drug Claims

    Sundial Herbal Products is recalling Mango Bark herbal products because they are misbranded and deemed unapproved drugs based on labeling claims.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***MANGO BARK***2 oz.***USES: KIDNEY STONE, HIGH BLOOD PRESSURE, RELATED TO NERVOUS CONDITIONS***"
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1495-2020·2020-09-09

    Sundial Traditional Herbal Formula Heart Recalled for Misbranding

    Sundial Herbal Products is recalling its Traditional Herbal Formula Heart product because it is misbranded and deemed an unapproved drug.

    Product
    "SUNDIAL***TRADITIONAL HERBAL FORMULA***HEART***" packaged in boxes
    Category
    Drug
    Distribution
    1 state