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.

8576–8600 of 26961

  • 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 cou
    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
    0 states
  • 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, Organ
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0308-2025·2024-11-13

    DeRoyal Children's Orthopedic Tracepack Smoke Evacuation Pencil Malfunction Recall

    DeRoyal is recalling 384 units of Children's Orthopedic TracePacks containing a Stryker smoke evacuation pencil that may activate unexpectedly or fail to deactivate, posing a burn risk during surgery.

    Product
    DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0097-2025·2024-11-13

    EM Tortillas Mexican sweet bread recalled for undeclared allergens

    EM Tortillas, LLC is recalling bulk Mexican sweet bread varieties due to undeclared wheat, soy, and egg allergens. Products are packaged in unlabeled poly bags and distributed in California.

    Product
    Bulk Mexican sweet bread varieties including conchas, fino ellotes, fino curenos, danes ellotes, danes cuernos, bolillos, and teleras. Bakery products are packaged in unlabeled poly bags.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0098-2025·2024-11-13

    Hammond's Dark Chocolate Waffle Cones Recalled for Undeclared Milk Allergen

    Hammond's Candies is recalling Dark Chocolate Filled Mini Waffle Cones nationwide due to undeclared milk allergen. Consumers with milk allergies should not consume this product.

    Product
    Hammond's Dark Chocolate Filled Mini Waffle Cones, packaged in a 4 oz (113g) Stand-Up Resealable Pouch. Item Number: FC23212; UPC 6 91355 90513 5. Label declares ***CONTAINS: WHEAT, SOY, TREE NUTS (COCONUT)***PACKAGED IN A FACILITY THAT PROCESSES EGG, MILK, MUSTARD, PEANUTS, SE
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0037-2025·2024-11-13

    Morphine Sulfate Extended-Release Tablets Recalled for Failed Impurities Specification

    Dr. Reddy's Laboratories is recalling Morphine Sulfate Extended-Release Tablets 30 mg (Lot FG13996) nationwide due to failed impurities and degradation specifications.

    Product
    Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-186-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0321-2025·2024-11-13

    Cardiac stress testing system recalled due to duplicate patient identifiers

    The Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System may assign duplicate unique identifiers to exam files, potentially causing patient identification mismatches with their cardiac test data.

    Product
    Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0326-2025·2024-11-13

    Smith & Nephew Bipolar Hip Implant Component Recalled for Oversized Retainer Ring

    Smith & Nephew is recalling 21 units of a Tandem Bipolar Hip System component due to an oversized retainer ring in the femoral head assembly. The affected devices were distributed internationally to nine countries.

    Product
    Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0285-2025·2024-11-13

    Endoscopic Vessel Harvesting System Recalled for Assembly Defect

    Zimmer recalls the Venapax XL endoscopic vessel harvesting system due to assembly defects that may cause endoscope interference during surgery. A Gen 5 tail piece was incorrectly assembled to Gen 4 devices, affecting 432 units nationwide.

    Product
    Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. Item Number: VPX4000 (7273)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0121-2025·2024-11-13

    Kirkland Signature Unsalted Butter Recalled for Missing Milk Allergen Label

    Kirkland Signature Unsalted Sweet Cream Butter is being recalled because the label lists cream as an ingredient but is missing the required 'Contains Milk' allergen statement. Consumers with milk allergies should not consume this product.

    Product
    Kirkland Signature Unsalted Sweet Cream Butter, Net Wt 16 oz (1 lb) 453g, Four 4 oz (113g) sticks UPC 96619-38496.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0322-2025·2024-11-13

    Electrocardiograph System May Assign Duplicate Identifiers to Patient Exams

    The Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System may assign duplicate file identifiers that could cause patient data to be mismatched in DICOM archive systems.

    Product
    Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; Electrocardiograph
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0320-2025·2024-11-13

    Hillrom HScribe Holter System cardiac monitoring devices duplicate identifier risk

    Hillrom HScribe Holter System monitoring devices may assign duplicate file identifiers, risking patient identification mismatches in medical systems that use the identifier to match patient data to cardiac recordings.

    Product
    Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0325-2025·2024-11-13

    Cardiac stress testing system may assign duplicate exam identifiers to patients

    Hillrom Welch Allyn XScribe cardiac stress testing systems may assign duplicate exam identifiers, potentially causing patient data mismatches in medical record systems.

    Product
    Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic Computer
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0318-2025·2024-11-13

    GE Healthcare Centricity Viewer Security Vulnerability Could Allow Unauthorized Access

    GE Healthcare's Centricity Universal Viewer Zero Footprint medical imaging software contains a security vulnerability that could allow unauthorized access and patient data manipulation. Approximately 120 units are affected worldwide.

    Product
    GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2089507-083, GDZH-JINWAN-Centricity 2) 2089507-093, 10510-3-Centricity Universal Viewer Zero Footprint / ZFP-02268286, 10510-3-Centricity Universal Viewer Zero Footprint / ZFP-02030900, 1495-1-Centric
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0309-2025·2024-11-13

    DeRoyal Surgical Procedure Pack Smoke Evacuation Pencil Recalled

    DeRoyal is recalling surgical procedure pack products containing a Stryker SafeAir Smoke Evacuation Pencil that may activate without manual input or remain active after buttons are released. The malfunction poses a risk of injury during surgical procedures.

    Product
    DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0286-2025·2024-11-13

    epoc BGEM BUN Test Cards recalled for sodium measurement bias

    Siemens recalled epoc BGEM BUN Test Cards for a negative sodium bias occurring approximately 2 months before expiration, with maximum observed bias of -10 mmol/L. No adverse events reported.

    Product
    epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0323-2025·2024-11-13

    Electrocardiograph DICOM Files Risk Patient Data Mismatch Due to Duplicate Identifiers

    Certain Hillrom Welch Allyn Vision Express Holter Analysis Systems may assign duplicate identifiers to cardiac exam files, risking mismatch between patient identities and their physiological data.

    Product
    Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph
    Category
    Medical Device
    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 (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-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-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, cit
    Category
    Food
    Distribution
    Distributed nationwide
  • 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-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