The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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12676–12700 of 114068

  • HighFDA (Drugs)·D-0039-2025·2024-11-13

    FDA Recalls Regadenoson Injection for Missing Label Information

    Baxter Healthcare Corporation is recalling 60,594 units of Regadenoson Injection nationwide due to missing label information on affected lot numbers. Healthcare providers with affected lots should contact the manufacturer for replacement supplies.

    Product
    REGADENOSON — REGADENOSON (REGADENOSON)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0122-2025·2024-11-13

    Kirkland Signature Butter Recalled for Missing Milk Allergen Statement

    Kirkland Signature Salted Sweet Cream Butter is being recalled because the packaging may lack the required 'Contains Milk' allergen warning. Consumers with milk allergies who purchased this product in Texas should not consume it.

    Product
    Kirkland Signature Salted Sweet Cream Butter, Net Wt 16 oz (1 lb) 453g, Four 4 oz (113g) sticks UPC 96619-38488.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0041-2025·2024-11-13

    Generic Ibuprofen 800mg Recalled Due to Failed Impurity and Degradation Specifications

    Direct Rx is recalling 1,410 bottles of Ibuprofen 800mg tablets distributed nationwide due to failed impurity specifications discovered during 18-month stability testing.

    Product
    Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, GA 30534, Mfg By: Dr. Reddy's Laboratories LA, LLC, Shreveport, LA 71106, a) NDC 61919-0621-15 (15 count bottles), b) NDC 61919-0621-30 (30…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0106-2025·2024-11-13

    MyChai Chai Tea Concentrate Recalled for pH Control and Documentation Issues

    MyChai Chai Tea Concentrate Original is recalled nationwide. The FDA found pH levels above 4.1 and missing production records.

    Product
    MyChai Chai Tea Concentrate Original. Product is packaged in plastic (HDPE) 1/2gallon bottle, cap has a foil liner that is induction sealed during the bottling process. Shelf stable 3 year expiration from date of manufacture. Ingredients: Water, Sugar, Organic Black Tea…
    Category
    Food
    Distribution
    Distributed nationwide
  • 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 (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 (Food)·F-0114-2025·2024-11-13

    MySyrup Sugar Free Hazelnut Syrup Recalled Due to Missing Production Records

    MySyrup Sugar Free Hazelnut Syrup (556 jugs) is being recalled nationwide because production records are missing for this acidified product, preventing verification of proper processing procedures.

    Product
    MySyrup Sugar Free Hazelnut Syrup. Product is packaged in the same square 0.5gallon HDPE plastic bottles and the volume is 68 fl oz. Ingredients: Water, natural and artificial flavor, potassium sorbate and sodium benzoate (to protect flavor), sucralose, acesulfame potassium…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0314-2025·2024-11-13

    Adult Cap-ONE Biteblock devices recalled for expired product distribution

    Nihon Kohden America Inc is recalling 17 Adult Cap-ONE Biteblock devices shipped after expiration dates. The single-use devices are intended for sampling CO2 and administering oxygen during endoscopy procedures.

    Product
    Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxygen, for patients who can wear a 20mm bite block, during endoscopy type procedures. The device is intended for single patient use only.
    Category
    Medical Device
    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-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…
    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
  • 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.…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0119-2025·2024-11-13

    Oregon Orchards Banana Smoothie Mix recalled for inadequate acidification documentation

    My Chai Inc is recalling Oregon Orchards Banana Smoothie Mix nationwide due to insufficient production records proving proper acidification. Consumers should not consume the product.

    Product
    Oregon Orchards Banana Smoothie Mix. Product is packaged in the same square 0.5gallon HDPE plastic bottles and the volume is 68 fl oz. Ingredients: Sugar, banana puree, water, natural flavor, citric acid, xanthan gum, sodium benzoate (to help protect flavor-1/10 of 1%), vanilla…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0315-2025·2024-11-13

    Biocare Medical Recalls IHC Kits Due to Potential Staining Failure

    Biocare Medical is recalling specific IHC kits containing DAB Buffer because they may produce weak or no staining, leading to test failure.

    Product
    intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE Pro DAB Chromogen, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60; IP DAB Chromogen Kit 80 ml, REF: IPK5010G80, containing DAB Buffer…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0316-2025·2024-11-13

    X-ray System Software May Fail to Display Images During Mode Switching

    SHIMADZU CORPORATION's SONIALVISION G4 X-ray system may occasionally fail to display images when switching from fluoroscopy to radiography mode. This could result in examination delays or cancellations.

    Product
    SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examinations, including general radiography and pediatric examinations, excluding mammography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0317-2025·2024-11-13

    Shimadzu FLUOROspeed X-ray System Software Recall for Image Display Failure

    Shimadzu is recalling 30 FLUOROspeed X-ray systems because software may fail to display images when switching modes, potentially delaying or canceling examinations.

    Product
    The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. FLUOROspeed may be used for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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…
    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…
    Category
    Food
    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…
    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…
    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…
    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 (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
    1 state
  • 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.…
    Category
    Food
    Distribution
    Distributed nationwide