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.

8726–8750 of 27089

  • ModerateFDA (Drugs)·D-0034-2025·2024-11-13

    OTC cough and congestion medication recalled for crystallization

    Denison Pharmaceuticals is recalling its Maximum Strength Cough and Chest Congestion medication due to crystallization in bottles. The product, distributed by Genexa Inc., may contain chunks, graininess, or crystal substances that affect uniformity.

    Product
    MAXIMUM STRENGTH COUGH AND CHEST CONGESTION AND NIGHTTIME SEVERE COLD AND FLU COMBO PACK — MAXIMUM STRENGTH COUGH AND CHEST CONGESTION AND NIGHTTIME SEVERE COLD AND FLU COMBO PACK (DEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN, DOXYLAMINE SUCCINATE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0311-2025·2024-11-13

    Intra-Aortic Balloon Catheters Recalled for Packaging Label Discrepancy

    Datascope Corp. is recalling 160 units of MEGA 7.5Fr intra-aortic balloon catheters due to discrepant labeling between inner and outer packaging, which could cause confusion about proper use.

    Product
    MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0111-2025·2024-11-13

    MySyrup Sugar Free Almond Syrup Recalled for Missing Production Records

    My Chai Inc is recalling MySyrup Sugar Free Almond Syrup due to missing production records. The recall affects 212 jugs with batch numbers and expiration dates from August 2023 through December 2024.

    Product
    MySyrup Sugar Free Almond Syrup. Product is packaged in the same square 0.5gallon HDPE plastic bottles and the volume is 68 fl oz. Ingredients: Water, natural flavor, Madagascar vanilla extract, sodium benzoate and potassium sorbate (to protect flavor), sucralose, acesulfame pot
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0284-2025·2024-11-13

    Canon Medical PET-CT System Software Malfunction Prevents Image Reconstruction

    27 Canon Cartesion Prime PET-CT imaging systems may experience software processing failures during simultaneous imaging of multiple patients, necessitating repeat examinations. The issue occurs when PET acquisition or reconstruction for another patient is performed while reconstruction is in progress.

    Product
    Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Food)·F-0116-2025·2024-11-13

    MySyrup Sugar Free Peppermint Syrup Recalled for Missing Production Records

    My Chai Inc is recalling MySyrup Sugar Free Peppermint Syrup (68 fl oz bottles) nationwide due to missing production records documenting the acidification process. No illnesses have been reported.

    Product
    MySyrup Sugar Free Peppermint Syrup. Product is packaged in the same square 0.5gallon HDPE plastic bottles and the volume is 68 fl oz. Ingredients: Water, natural flavor, sodium benzoate and potassium sorbate (to protect flavor), sucralose, acesulfame potassium, citric acid. Ma
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0038-2025·2024-11-13

    Dapsone Gel 7.5% recalled nationwide due to crystallization

    Viona Pharmaceuticals is recalling Dapsone Gel 7.5% due to crystallization. The voluntary recall covers 6,048 pumps distributed nationwide in the United States.

    Product
    DAPSONE — DAPSONE (DAPSONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0033-2025·2024-11-13

    OTC Cold and Cough Medication Recalled Due to Crystallization

    Denison Pharmaceuticals recalls Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo Pack due to crystallization and texture changes in affected bottles.

    Product
    MAXIMUM STRENGTH COUGH AND CHEST CONGESTION AND NIGHTTIME SEVERE COLD AND FLU COMBO PACK — MAXIMUM STRENGTH COUGH AND CHEST CONGESTION AND NIGHTTIME SEVERE COLD AND FLU COMBO PACK (DEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN, DOXYLAMINE SUCCINATE)
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Food)·F-0110-2025·2024-11-13

    MyChai Chai Tea Concentrate recalled for missing production records

    My Chai Inc is recalling 19,171 jugs of MyChai Chai Tea Concentrate Original Double distributed nationwide due to missing production records.

    Product
    MyChai Chai Tea Concentrate Original Double. Product is packaged in the same square 0.5 gallon HDPE plastic bottles and have volumes of 68 fl oz. Ingredients: Water, Sugar, Organic Black Tea, Organic Spices, Molasses, Vanilla Extract, Citric Acid, Natural Flavors. Made by: MyCh
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0288-2025·2024-11-13

    iotaSOFT Plus Drive Unit Recalled Due to Incorrect GTIN Number

    Iotamotion Inc. is recalling the iotaSOFT Plus Drive Unit (Lot #D500330) due to an incorrect GTIN number on the product label. Five devices were distributed in Iowa.

    Product
    iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of implant insertion.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Food)·F-0117-2025·2024-11-13

    MySyrup Sugar Free Raspberry Syrup Recalled Due to Missing Production Records

    My Chai Inc is recalling MySyrup Sugar Free Raspberry Syrup (491 units, 68 fl oz bottles) distributed nationwide due to lack of production records for this acidified food product.

    Product
    MySyrup Sugar Free Raspberry Syrup. Product is packaged in the same square 0.5gallon HDPE plastic bottles and the volume is 68 fl oz. Ingredients: Water, natural flavor, vanilla extract, sodium benzoate and potassium sorbate (to protect flavor), sucralose, acesulfame potassium,
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0108-2025·2024-11-13

    MyChai Chai Tea Concentrate Recalled for Missing Production Records

    My Chai Inc is recalling 11,202 jugs of MyChai Chai Tea Concentrate nationwide due to missing production records.

    Product
    MyChai Chai Tea Concentrate Double. Product is packaged in the same square 0.5 gallon HDPE plastic bottles and have volumes of 68 fl oz. Ingredients: Water, Sugar, Organic Black Tea, Organic Spices, Molasses, Vanilla Extract, Citric Acid, Natural Flavors. Made by: MyChai, Inc.
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0118-2025·2024-11-13

    MySyrup Sugar Free Salted Caramel Syrup recalled due to missing production records

    My Chai Inc is recalling MySyrup Sugar Free Salted Caramel Syrup nationwide due to lack of production records documenting acidification procedures.

    Product
    MySyrup Sugar Free Salted Caramel Syrup. Product is packaged in the same square 0.5gallon HDPE plastic bottles and the volume is 68 fl oz. Ingredients: Water, natural flavor, potassium sorbate and sodium benzoate (to protect flavor), sucralose, acesulfame potassium, citric acid.
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0115-2025·2024-11-13

    MySyrup Sugar Free Madagascar Vanilla Syrup Recalled for Missing Production Records

    My Chai Inc is recalling MySyrup Sugar Free Madagascar Vanilla Syrup nationwide due to missing production records for the acidified product.

    Product
    MySyrup Sugar Free Madagascar Vanilla Syrup. Product is packaged in the same square 0.5gallon HDPE plastic bottles and the volume is 68 fl oz. Ingredients: Water, Madagascar vanilla extract, sodium benzoate and potassium sorbate (to protect flavor), sucralose, acesulfame potassi
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0109-2025·2024-11-13

    MyChai Chai Tea Concentrate Recalled Due to Missing Production Records

    MyChai Chai Tea Concentrate is being recalled nationwide due to missing production records. The manufacturer could not provide documentation of the product's manufacturing process.

    Product
    MyChai Chai Tea Concentrate Super. Product is packaged in the same square 0.5 gallon HDPE plastic bottles and have volumes of 68 fl oz. Ingredients: Water, Sugar, Organic Black Tea, Organic Spices, Molasses, Vanilla Extract, Citric Acid, Natural Flavors. Made by: MyChai, Inc. 1
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0112-2025·2024-11-13

    MySyrup Sugar Free Caramel Syrup Recalled for Missing Production Records

    My Chai Inc is recalling MySyrup Sugar Free Caramel Syrup (604 jugs, nationwide distribution) due to missing production records that prevent verification of proper processing.

    Product
    MySyrup Sugar Free Caramel Syrup. Product is packaged in the same square 0.5gallon HDPE plastic bottles and the volume is 68 fl oz. Ingredients: Water, natural flavor, potassium sorbate and sodium benzoate (to protect flavor), sucralose, acesulfame potassium, citric acid. Made b
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0113-2025·2024-11-13

    MySyrup Sugar Free Coconut Syrup Recalled for Missing Production Records

    My Chai Inc is recalling 297 jugs of MySyrup Sugar Free Coconut Syrup nationwide due to missing production records. Consumers should not use the product.

    Product
    MySyrup Sugar Free Coconut Syrup. Product is packaged in the same square 0.5gallon HDPE plastic bottles and the volume is 68 fl oz. Ingredients: Water, natural flavor, potassium sorbate and sodium benzoate (to protect flavor), sucralose, acesulfame potassium, citric acid. Made
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0077-2025·2024-11-06

    Los Andes Foods Sweet Corn Pancakes Recalled for Undeclared Wheat Allergen

    Los Andes Foods Sweet Corn Pancakes are being recalled because they contain undeclared wheat allergen. Consumers with wheat allergies should not consume the product and should discard it.

    Product
    Los Andes Foods Sweet Corn Pancakes, Cachapas de Maiz, NET WT. 24 Oz., 5 units, KEEP REFRIGERATED
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0089-2025·2024-11-06

    Ginger Chicken Broccoli Salad Kit Recalled for Listeria Contamination

    Reser's Fine Foods is recalling Ginger Chicken Broccoli Salad Kit V due to potential Listeria monocytogenes contamination in the cooked chicken. The product was distributed to 31 states.

    Product
    Item 404790, UPC 13454 38101, Ginger Chicken Broccoli Salad Kit V, 1/6.9625lb. Distributed by Fresh Creative Foods Vista, CA.
    Category
    Food
    Distribution
    30 states
  • SevereFDA (Food)·F-0075-2025·2024-11-06

    Enoki Mushroom Recall Due to Listeria Monocytogenes Contamination

    Enoki mushroom packages distributed across seven states are being recalled due to Listeria monocytogenes contamination. Consumers should not consume the affected product and should return it to the point of purchase.

    Product
    (Principal Display) ENOKI MUSHROOM Champignons d'enoki Net Wt: 150g (5.3oz) in a clear plastic packaged. (Back Display) UPC 860011505600 Keep Refrigerated Garder Au Froid Distributed by: Global Fresh Marketing Commerce, CA 90040
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-0088-2025·2024-11-06

    Reser's Caesar Salad Kits Recalled for Listeria Contamination

    Reser's Fine Foods is recalling Caesar Salad Kits due to Listeria monocytogenes contamination in the cooked chicken component. The recall affects 21,098 cases distributed across 31 U.S. states.

    Product
    Item 401311, UPC 13454 35855, Caesar Salad Kit 2/6 lbs. Distributed by Fresh Creative Foods Vista, CA.
    Category
    Food
    Distribution
    30 states
  • SevereFDA (Food)·F-0120-2025·2024-11-06

    Shirakiku Korean Seaweed Recalled for Undeclared Sesame Allergen

    Wismettac Asian Foods recalls Shirakiku Korean Seasoned Seaweed due to incorrect product labeling that fails to disclose sesame. Affected products were distributed in CA, AZ, TX, NM, WA, NY, and NV.

    Product
    The outer package of the recalled product, Shirakiku Korean Seasoned Seaweed Korean Seaweed, is INCORRECTLY labeled as follows: (Principal Display Panel) Roasted Seaweed 10-0.91 OZ (26 G) PACKAGES (NET WT 9.1 OZ (260 G). (Back Display) ROASTED SEAWEED Organic Yaki Nori Ingredient
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Devices)·Z-0222-2025·2024-11-06

    Ambulatory Infusion System Batteries May Short Circuit and Overheat

    CADD-Solis battery packs used in ambulatory infusion systems may develop internal short circuits causing battery case melting and charging circuit failure. The FDA Class I recall affects 138,039 units worldwide.

    Product
    CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD Solis Ambulatory Infusion Systems: 21-2101-0100-50, 21-2101-0200-02, 21-2101-0200-03, 21-2101-0200-06, 21-2101-0200-07, 21-2101-0200-12, 21-2101-0200-14, 21-210
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0128-2025·2024-11-06

    Dakota Toms Bacon Cheeseburger Recalled for Potential Listeria Contamination

    Dakota Toms Bacon Cheeseburger (5.7 oz) is being recalled due to potential Listeria monocytogenes contamination. The recall affects 1700 sandwiches distributed in North Dakota, South Dakota, Wyoming, Iowa, and Minnesota with expiration dates from September 1 through November 28, 2024.

    Product
    Bacon Cheeseburger , Dakota Toms brand, Net Wt 5.7 oz, individual pre-packaged components in MEP packaging, UPC 737296803007
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0073-2025·2024-11-06

    Jack & the Green Sprouts Alfalfa Recalled for Possible Listeria Contamination

    Jack & the Green Sprouts Alfalfa sprouts (5 oz containers) are being recalled due to potential Listeria monocytogenes contamination. Affected products were distributed in Iowa, Minnesota, and Wisconsin.

    Product
    Jack & the Green Sprouts Alfalfa, Net Weight 5 oz (142g). UPC 7 63247-19891 5 Keep Refrigerated. Product of USA. Jackandthegreensprouts.com, River Falls, WI 54022. EXPANDED 10/4/2024: Product was packaged in 5 oz containers that were packed in 6 count or 12 count shippi
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0092-2025·2024-11-06

    VasoView HemoPro Vessel Harvesting System Recalled for Silicone Component Detachment

    Maquet Cardiovascular is recalling the VasoView HemoPro Endoscopic Vessel Harvesting System due to silicone detachment from the Harvesting Tool Jaws during use. This FDA Class I recall affects 28,809 units worldwide.

    Product
    VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500
    Category
    Medical Device
    Distribution
    Distributed nationwide