The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

10151–10175 of 27089

  • ModerateFDA (Food)·F-1615-2024·2024-08-14

    Urban River Spirits Raspberry Lemon Mixer recalled for potential under-processing

    Urban River Spirits is recalling Raspberry Lemon Mixer because the product was manufactured in an unlicensed and uninspected facility. The recall concerns potential under-processing issues.

    Product
    Raspberry Lemon Mixer is a non-alcoholic cocktail mixer. Product is packaged in glass 750ml bottle and sold under brand Urban River Spirits. Label has listed instructions as Shake Well Refrigerated After Opening.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1620-2024·2024-08-14

    Non-alcoholic cocktail mixer made in unlicensed facility recalled

    Urban River Spirits is recalling its Lemon Drop Mixer due to being manufactured in an unlicensed, uninspected facility with potential under-processing concerns affecting product safety. The product was distributed across multiple states.

    Product
    Lemon Drop Mixer is a non-alcoholic cocktail mixer. Product is packaged in glass 750ml bottle and sold under brand Urban River Spirits. Label has listed instructions as Shake Well Refrigerated After Opening.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1623-2024·2024-08-14

    Keep It Spicy cocktail mixer recalled for potential under-processing

    Urban River Spirits recalled Keep It Spicy Pear & Jalapeno Mixer because it was produced in an unlicensed, uninspected facility with potential under-processing. The product was distributed across 11 states.

    Product
    Keep It Spicy Pear & Jalapeno Mixer is a non-alcoholic cocktail mixer. Product is packaged in glass 750ml bottle and sold under brand Urban River Spirits. Label has listed instructions as Shake Well Refrigerated After Opening.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1638-2024·2024-08-14

    Brown Sugar Simple Syrup Recalled for Potential Under-Processing

    Urban River Spirits is recalling Brown Sugar Simple Syrup due to manufacture in an unlicensed, uninspected facility with potential under-processing concerns.

    Product
    Brown Sugar Simple Syrup is a non-alcoholic cocktail mixer. Product is packaged in glass 5oz. bottle and sold under brand Urban River Spirits.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1626-2024·2024-08-14

    Non-alcoholic cocktail mixer recalled for potential under-processing

    Urban River Spirits is recalling Lush Lavender & Wildberry Spritz non-alcoholic mixer due to potential under-processing. The product was manufactured in an unlicensed and uninspected facility.

    Product
    Lush Lavender & Wildberry Spritz is a non-alcoholic cocktail mixer. Product is packaged in glass 750ml bottle and sold under brand Urban River Spirits. Label has listed instructions as Shake Well Refrigerated After Opening.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1619-2024·2024-08-14

    Urban River Spirits Grapefruit Mixer Recalled for Potential Under-Processing

    Urban River Spirits is recalling Ruby-Red Grapefruit Mixer due to potential under-processing of the non-alcoholic beverage made in an unlicensed facility. No illnesses have been reported.

    Product
    Ruby-Red Grapefruit Mixer is a non-alcoholic cocktail mixer. Product is packaged in glass 750ml bottle and sold under brand Urban River Spirits. Label has listed instructions as Shake Well Refrigerated After Opening.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0628-2024·2024-08-14

    PEG-3350 Oral Solution Recalled for Defective Non-Sealed Pouches

    A PEG-3350 oral solution is being recalled nationwide due to defective pouches that may not be properly sealed, risking product leakage. The recall affects 13,200 cartons with lot number S300542.

    Product
    PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID — PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID (PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1631-2024·2024-08-14

    Urban River Spirits Cocktail Mixer Recalled for Under-Processing Risk

    Urban River Spirits is recalling Tropical Lime & Coconut non-alcoholic mixer because it was manufactured in an unlicensed facility with potential under-processing. No illnesses have been reported.

    Product
    Tropical Lime & Coconut is a non-alcoholic cocktail mixer. Product is packaged in glass 750ml bottle and sold under brand Urban River Spirits. Label has listed instructions as Shake Well Refrigerated After Opening.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2504-2024·2024-08-14

    Soltive Premium SuperPulsed Laser System Wireless Footswitch Pairing Difficulties

    The Soltive Premium SuperPulsed Laser System may experience difficulties pairing its wireless footswitch, potentially delaying surgical procedures. The recall affects units distributed worldwide.

    Product
    Soltive Premium SuperPulsed Laser System, Model TFL-PLS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1624-2024·2024-08-14

    Non-alcoholic cocktail mixer recalled due to facility and processing concerns

    Urban River Spirits recalls Tropical Blackberry cocktail mixer (3,876 bottles) due to manufacturing in an unlicensed, uninspected facility with potential under-processing. No illnesses reported.

    Product
    Tropical Blackberry is a non-alcoholic cocktail mixer. Product is packaged in glass 750ml bottle and sold under brand Urban River Spirits. Label has listed instructions as Shake Well Refrigerated After Opening.
    Category
    Food
    Distribution
    0 states
  • LowFDA (Devices)·Z-2535-2024·2024-08-14

    NavaClick Syringe and Needle Model LIN02 Recalled for Incorrect Carton GTIN Label

    Lineage Biomedical is recalling NavaClick Syringe and Needle Model LIN02 due to an incorrect GTIN number on carton packaging. The recall affects 215 cartons distributed in Michigan and South Carolina.

    Product
    NavaClick Syringe and Needle, Model Number LIN02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0625-2024·2024-08-14

    Sevelamer Carbonate for Oral Suspension missing lot and expiration date labels

    Dr. Reddy's Laboratories is recalling Sevelamer Carbonate for Oral Suspension packets missing lot number and expiration date information. Approximately 5,136 cartons were distributed nationwide.

    Product
    SEVELAMER CARBONATE FOR ORAL SUSPENSION — SEVELAMER CARBONATE FOR ORAL SUSPENSION (SEVELAMER CARBONATE FOR ORAL SUSPENSION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1535-2024·2024-08-07

    Diamond Shruumz Gummies Recalled for Toxic Levels of Muscimol

    Diamond Shruumz Gummies (Micro Dose Sour Peach Apple) manufactured by Prophet Premium Blends, LLC, are being recalled by the FDA due to toxic levels of muscimol. The Class I recall affects approximately 248,007 products distributed nationwide.

    Product
    Diamond Shruumz Gummies - Micro Dose Sour Peach Apple UPC 755003861386
    Category
    Food
    Distribution
    51 states
  • CriticalFDA (Drugs)·D-0620-2024·2024-08-07

    Dietary Supplement Recalled for Undeclared Diclofenac and Omeprazole

    SoloVital's Umary Hyaluronic Acid supplement was recalled because FDA testing found it contains undeclared Diclofenac and Omeprazole. The product, marketed without approved NDA/ANDA, affected 1,331 bottles distributed nationwide.

    Product
    Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1540-2024·2024-08-07

    Diamond Shruumz Gummies recalled for toxic muscimol levels

    Diamond Shruumz Gummies Mega/Extreme Dose Peach Paradise contain toxic levels of muscimol. The FDA is recalling all 248,007 units distributed nationwide.

    Product
    Diamond Shruumz Gummies - Mega/Extreme Dose Peach Paradise UPC 810133320384
    Category
    Food
    Distribution
    51 states
  • SevereFDA (Food)·F-1538-2024·2024-08-07

    Diamond Shruumz Gummies Blue Razz recalled for toxic muscimol levels

    Prophet Premium Blends is recalling Diamond Shruumz Gummies Blue Razz containing toxic levels of muscimol. The product has been distributed nationwide across all U.S. states and territories.

    Product
    Diamond Shruumz Gummies - Mega/Extreme Dose Blue Razz Euphoria UPC 810133320346
    Category
    Food
    Distribution
    51 states
  • SevereFDA (Food)·F-1526-2024·2024-08-07

    Diamond Shruumz Chocolate Bars Recalled for Toxic Muscimol Contamination

    Diamond Shruumz Chocolate Bars Cookies & Cream are being recalled due to toxic levels of muscimol. The FDA Class I recall affects approximately 248,007 products distributed nationwide.

    Product
    Diamond Shruumz Chocolate Bars Cookies & Cream UPC 755003858782
    Category
    Food
    Distribution
    51 states
  • SevereFDA (Drugs)·D-0619-2024·2024-08-07

    Potassium Chloride Extended-Release Capsules Recalled Over Failed Dissolution

    Amerisource Health Services LLC is recalling 61,231 bottles of Potassium Chloride Extended-Release Capsules nationwide due to failed dissolution specifications. The medication may not release properly, potentially affecting dosing accuracy.

    Product
    POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1523-2024·2024-08-07

    Diamond Shruumz Cones Sprinkles Recalled for Toxic Muscimol Levels

    Prophet Premium Blends, LLC is recalling Diamond Shruumz Infused Cones Sprinkles due to toxic levels of muscimol. The recall affects approximately 248,007 products distributed nationwide.

    Product
    Diamond Shruumz Infused Cones Sprinkles UPC 810133320063
    Category
    Food
    Distribution
    51 states
  • SevereFDA (Food)·F-1531-2024·2024-08-07

    Diamond Shruumz Chocolate Bars Recalled Due to Toxic Muscimol Levels

    Prophet Premium Blends is recalling Diamond Shruumz Chocolate Bars Fruity Cereal due to toxic levels of muscimol contamination. Products have been distributed nationwide across the United States.

    Product
    Diamond Shruumz Chocolate Bars Fruity Cereal UPC 755003858799
    Category
    Food
    Distribution
    51 states
  • SevereFDA (Food)·F-1521-2024·2024-08-07

    Diamond Shruumz Infused Cones Recalled for Toxic Muscimol Levels

    Diamond Shruumz Infused Cones Cookies and Cream are being recalled due to toxic levels of muscimol. The FDA Class I recall affects approximately 248,007 units distributed nationwide.

    Product
    Diamond Shruumz Infused Cones Cookies and Cream UPC 810133320025
    Category
    Food
    Distribution
    51 states
  • SevereFDA (Food)·F-1533-2024·2024-08-07

    Diamond Shruumz Grape Lemonade Gummies recalled for toxic muscimol levels

    Diamond Shruumz Gummies - Micro Dose Grape Lemonade (UPC 755003861584) are being recalled by the FDA due to toxic levels of muscimol. The product was distributed across all U.S. states, affecting approximately 248,007 units.

    Product
    Diamond Shruumz Gummies - Micro Dose Grape Lemonade UPC 755003861584
    Category
    Food
    Distribution
    51 states
  • SevereFDA (Food)·F-1528-2024·2024-08-07

    Diamond Shruumz Chocolate Bars Cinnamon Bar Recalled for Toxic Muscimol Levels

    Prophet Premium Blends is recalling Diamond Shruumz Chocolate Bars Cinnamon Bar products nationwide due to toxic levels of muscimol. Approximately 248,007 units were affected.

    Product
    Diamond Shruumz Chocolate Bars Cinnamon Bar UPC 755003858836
    Category
    Food
    Distribution
    51 states
  • SevereFDA (Food)·F-1532-2024·2024-08-07

    Diamond Shruumz Gummies Recalled for Toxic Muscimol Levels

    Diamond Shruumz Gummies - Micro Dose Blue Raz Watermelon are being recalled nationwide due to toxic levels of muscimol. All lots are affected.

    Product
    Diamond Shruumz Gummies - Micro Dose Blue Raz Watermelon UPC 755003861362
    Category
    Food
    Distribution
    51 states
  • SevereFDA (Food)·F-1530-2024·2024-08-07

    Diamond Shruumz Chocolate Bars recalled for toxic muscimol contamination

    Prophet Premium Blends, LLC is recalling Diamond Shruumz Chocolate Bars Dark Chocolate due to toxic levels of muscimol. All lots distributed nationwide should not be consumed.

    Product
    Diamond Shruumz Chocolate Bars Dark Chocolate UPC 755003858829
    Category
    Food
    Distribution
    51 states