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.

12051–12075 of 88183

  • ModerateFDA (Food)·F-1627-2024·2024-08-14

    Non-Alcoholic Cocktail Mixer Recalled Due to Facility Safety Concerns

    Cafe Caramel Delight, a non-alcoholic cocktail mixer, is being recalled because it was produced in an unlicensed, uninspected facility with potential under-processing concerns.

    Product
    Cafe Caramel Delight 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
    11 states
  • ModerateFDA (Food)·F-1618-2024·2024-08-14

    Non-Alcoholic Cocktail Mixer Recalled for Facility Safety and Under-Processing Concerns

    Urban River Spirits is recalling 3,876 bottles of Spicy Cool-aid: Watermelon & Jalapeno due to potential under-processing. The product was manufactured in an unlicensed and uninspected facility.

    Product
    Spicy Cool-aid: Watermelon & Jalapeno 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
    11 states
  • ModerateFDA (Food)·F-1625-2024·2024-08-14

    Non-Alcoholic Cocktail Mixer from Urban River Spirits Recalled for Potential Under-Processing

    Urban River Spirits is recalling Peppered Peach Bliss, a non-alcoholic cocktail mixer, due to potential under-processing risks. The product was manufactured in an unlicensed and uninspected facility.

    Product
    Peppered Peach Bliss 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
    11 states
  • ModerateFDA (Food)·F-1652-2024·2024-08-14

    Frozen Cornbread Muffins Recalled Due to Manufacturing and Sanitation Violations

    Frozen Food Processors recalls frozen cornbread muffins manufactured without state license and in unsanitary conditions. The recall affects approximately 1,862 cases distributed in MS, TN, LA, AR, and AL.

    Product
    Frozen Food Processors - Regular Cornbread Muffins packaged in 2oz corrugated cardboard boxes lined with food grade plastic bags. Keep frozen at 0F or lower until time of use. 96 individual muffins per case.
    Category
    Food
    Distribution
    5 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
    11 states
  • ModerateFDA (Food)·F-1629-2024·2024-08-14

    Non-Alcoholic Cocktail Mixer Recalled Due to Unlicensed Facility Production

    Urban River Spirits recalls Sunkissed Lavender and Lemon non-alcoholic cocktail mixer (750ml glass bottles) manufactured in an unlicensed, uninspected facility due to potential under-processing concerns.

    Product
    Sunkissed Lavender and Lemon 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
    11 states
  • ModerateFDA (Food)·F-1630-2024·2024-08-14

    Urban River Spirits Velvet Cocoa and Caramel Mixer Recalled for Potential Under-Processing

    Urban River Spirits voluntarily recalls Velvet Cocoa and Caramel cocktail mixer due to potential under-processing from manufacture in an unlicensed, uninspected facility. Product distributed across 11 states.

    Product
    Velvet Cocoa and Caramel 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
    11 states
  • ModerateFDA (Food)·F-1637-2024·2024-08-14

    Maple Infused Simple Syrup Recalled Due to Potential Under-Processing

    Urban River Spirits recalls 3876 bottles of Maple Infused Simple Syrup distributed across multiple states. The product was manufactured in an unlicensed, uninspected facility and may be under-processed.

    Product
    Maple Infused 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
    11 states
  • ModerateFDA (Devices)·Z-2506-2024·2024-08-14

    Wireless Footswitch for Soltive Laser System Recalled for Pairing Difficulties

    Olympus Corporation of the Americas is recalling 1,838 units of the Soltive SuperPulsed Laser System Wireless Footswitch due to pairing difficulties that may delay surgical procedures.

    Product
    Soltive SuperPulsed Laser System Wireless Footswitch, Model TFL-AFSWL
    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
    11 states
  • 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
    11 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-1632-2024·2024-08-14

    Non-Alcoholic Cocktail Mixer Recalled for Potential Under-Processing Risk

    Urban River Spirits is recalling Summer Sunset Strawberry and Peach non-alcoholic cocktail mixer from multiple states because it was manufactured in an unlicensed and uninspected facility, creating potential under-processing concerns.

    Product
    Summer Sunset Strawberry and Peach 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
    11 states
  • ModerateFDA (Food)·F-1633-2024·2024-08-14

    Non-alcoholic cocktail mixer recalled due to unlicensed production facility

    Urban River Spirits is recalling Raspberry and Peach Melody non-alcoholic cocktail mixer due to concerns over potential under-processing. The product was manufactured in an unlicensed and uninspected facility.

    Product
    Raspberry and Peach Melody 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
    11 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-1653-2024·2024-08-14

    Frozen Jalapeno Cornbread Muffins Recalled for Unsanitary Manufacturing

    Frozen Food Processors recalls Jalapeno Cornbread Muffins due to manufacturing without state license and in unsanitary conditions. 259 cases were distributed to five states.

    Product
    Frozen Food Processors - Jalapeno Cornbread Muffins packaged in 2oz corrugated cardboard boxes lined with food grade plastic bags. Keep frozen at 0F or lower until time of use. 96 individual muffins per case.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-1622-2024·2024-08-14

    Pear-Tini Mixer recalled due to production in unlicensed facility

    Urban River Spirits is recalling Pear-Tini Mixer because it was made in an unlicensed and uninspected facility. The product may not have been properly processed.

    Product
    Pear-Tini 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
    11 states
  • ModerateFDA (Food)·F-1616-2024·2024-08-14

    Life s a Peach Spritzer Recalled for Unlicensed Facility and Under-Processing

    Urban River Spirits Life s a Peach Spritzer is recalled because it was manufactured in an unlicensed, uninspected facility with potential under-processing. No illnesses have been reported.

    Product
    Life s a Peach Spritzer 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
    11 states
  • ModerateFDA (Drugs)·D-0629-2024·2024-08-14

    Methotrexate tablets may contain wrong medication, FDA says

    Amneal Pharmaceuticals recalls Methotrexate 2.5mg tablets (Lot BB29124) distributed nationwide due to potential presence of Fludrocortisone Acetate tablets. Patients should verify their lot number with their pharmacy.

    Product
    Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-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
  • 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-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
  • SevereFDA (Food)·F-1525-2024·2024-08-07

    Diamond Shruumz Infused Cones Recalled for Toxic Muscimol Levels

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

    Product
    Diamond Shruumz Infused Cones Strawberry Cheesecake UPC 810133320087
    Category
    Food
    Distribution
    51 states