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.

8251–8275 of 27089

  • HighFDA (Drugs)·D-0096-2025·2024-12-11

    Prescription Drug Diltiazem Hydrochloride Recalled for Manufacturing Impurity

    Glenmark Pharmaceuticals is recalling 5,232 bottles of Diltiazem Hydrochloride Extended-Release Capsules nationwide due to an impurity that exceeds FDA safety limits. Patients currently taking this medication should contact their pharmacist or doctor.

    Product
    DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0630-2025·2024-12-11

    Medline Surgical Kits Recalled Due to Defective Smoke Evacuation Component

    Medline is recalling 167,074 surgical convenience kits nationwide containing SafeAir Smoke Evacuation Pencils previously recalled by manufacturer Stryker for use in various surgical procedures.

    Product
    MEDLINE convenience kits labeled as: 2) ABDOMINAL LAPAROSCOPY, REF CDS760057K; 3) ABDOMINAL LAPAROSCOPY, REF CDS760057L; 4) MAJOR LAPAROTOMY CDS, REF CDS860015W; 5) MINOR LAPAROTOMY CDS, REF CDS860016P; 6) MINOR LAPAROTOMY CDS, REF CDS860016Q; 7) MINOR LAPAROTOMY CDS, REF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0640-2025·2024-12-11

    MEDLINE convenience kits recalled due to defective component

    Medline is recalling multiple lots of its convenience kits because they contain a component (SafeAir Smoke Evacuation Pencil) that was previously recalled by Stryker. The affected kits are distributed nationwide.

    Product
    MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC NEURO PACK, REF CDS780202Q; 3) BASIC NEURO PACK, REF CDS780202R; 4) ACDF CDS, REF CDS941061M; 5) NEURO KIT, REF CDS981327Q; 6) ZALE V-P SHUNT CDS, REF CDS983186J; 7) NEURO PACK-LF, R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0578-2025·2024-12-11

    Ziehm Vision RFD X-ray System Hand Switch May Cause Unintended Radiation

    Orthoscan's Ziehm Vision RFD fluoroscopic x-ray systems may have wired hand switches that fail under mechanical stress, potentially causing unintended radiation. The manufacturer is recalling affected units in the U.S. and Puerto Rico.

    Product
    Ziehm Vision RFD. Interventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0227-2025·2024-12-11

    Katy's KITCHEN Gelatin Mix Recalled for Metal Fragments

    Katy's KITCHEN Originals gelatin mix products are being recalled because a damaged sifter introduced metal fragments during manufacturing. The affected flavors are Lemon, Lime, and Orange, distributed across 29 states.

    Product
    Katy's KITCHEN Originals LEMON GELATIN MIX MEXCLA DE GELATINA DE LIMON, NET WT. 24 OZ. (1.5 LBS.) 680 g, UPC 8 22486 11794 8, Case UPC 30822486117918; Katy's KITCHEN Originals LIME GELATIN MIX, NET WT. 24 OZ. (1.5 LBS.) 680 g, UPC 8 22486 11795 5 & Katy's KITCHEN Originals ORANGE
    Category
    Food
    Distribution
    30 states
  • HighFDA (Devices)·Z-0629-2025·2024-12-11

    MEDLINE Surgical Convenience Kits Recalled for Defective Smoke Evacuation Pencil Component

    MEDLINE is recalling 102 varieties of surgical convenience kits containing SafeAir Smoke Evacuation Pencils that have been recalled by manufacturer Stryker. The nationwide recall affects 24,754 units.

    Product
    MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I; 2) ENT MINOR, REF CDS983466L; 3) EAR, REF CDS983486K; 4) HEAD AND NECK, REF CDS984259N; 5) HEAD AND NECK, REF CDS984259O; 6) HEAD & NECK CDS, REF CDS984282L; 7) T & A, REF CDS984895I; 8) T & A,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0240-2025·2024-12-11

    THIRSTER Lemonade Drink Mix Recalled for Metal Fragment Contamination

    DYMA Brands recalls THIRSTER Lemonade Drink Mix because a damaged sifter used in dextrose production introduced metal fragments into the product. The product was distributed to 29 states.

    Product
    THIRSTER Lemonade Drink Mix NATURALLY FLAVORED LOW CALORIE, NET WT. 8.6 OZ (244 g), UPC 7 58108 39736 4, Case UPC 50758108397359, DISTRIBUTED BY US FOODS, INC. ROSEMONT, IL 60018
    Category
    Food
    Distribution
    30 states
  • HighFDA (Devices)·Z-0606-2025·2024-12-11

    CT imaging system issue causes progressive image rotation during scans

    GE Healthcare CT systems have a technical issue causing progressive image rotation during helical and cardiac scans. No injuries reported, but unnoticed rotation could affect diagnosis or require rescans.

    Product
    GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0233-2025·2024-12-11

    Sysco Pink Lemonade Drink Mix Recalled for Metal Fragment Contamination

    Sysco Classic Pink Lemonade Drink Mix is recalled because a damaged sifter during production introduced metal fragments into the product. Products were distributed across 29 states.

    Product
    Sysco Classic Pink Lemonade Drink Mix Natural Flavor, NET WT. 24OZ(1 LB 8 OZ) 680 g, UPC 0 74865 09326 2, Case UPC 10074865093269, DISTRIBUTED BY SYSCO CORPORATION, HOUSTON, TEXAS 77077
    Category
    Food
    Distribution
    30 states
  • HighFDA (Drugs)·D-0097-2025·2024-12-11

    Diltiazem extended-release capsules recalled for manufacturing impurity

    Glenmark Pharmaceuticals is recalling 4,704 bottles of Diltiazem Hydrochloride extended-release capsules 90mg due to manufacturing contamination with an impurity above FDA limits. Two lot numbers distributed nationwide are affected.

    Product
    DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0621-2025·2024-12-11

    BD Bacterial Susceptibility Test Discs Recall for Decreased Potency

    Becton Dickinson recalled BD BBL Sensi Disc Ampicillin 2 μg test discs due to 65% potency loss over 18 months that may produce false resistant results in susceptibility testing.

    Product
    BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) are used for semi-quantitative in vitro susceptibility testing by the agar disc diffusion test procedure of common, rapidly growing and certain fastidious bacterial pathogens. Catalog
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0586-2025·2024-12-11

    Medical Device Data Management Software Affected by Unauthorized Service Credential Access

    Service credentials for BD EpiCenter Data Management System were accessed by an unauthorized actor. This creates a risk of unauthorized access to the software and associated data until credentials are updated.

    Product
    BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0611-2025·2024-12-11

    GE Healthcare CT System May Produce Rotated Diagnostic Images

    GE Healthcare's Revolution Maxima M and related CT systems may produce progressively rotated images during scans, potentially compromising diagnostic accuracy. Rotation increases with each image, reaching up to 56 degrees.

    Product
    GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed tomography system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0224-2025·2024-12-11

    Ellington Farms Lemonade Drink Mix recalled for metal fragment contamination

    Ellington Farms Lemonade Drink Mix is being recalled due to metal fragments introduced during dextrose production. No illnesses have been reported. The product was distributed to 29 states.

    Product
    ELLINGTON FARMS LEMONADE DRINK MIX NATURAL FLAVOR, Net Wt. 24 oz (1.5 lbs) 680g, UPC 0 46045 06155 2, Case UPC 50719098505490, Distributed by: Ben E. Keith Foods, Fort Worth, TX 76101
    Category
    Food
    Distribution
    30 states
  • HighFDA (Devices)·Z-0632-2025·2024-12-11

    MEDLINE Port Insertion Pack Recalled for Defective Component

    Medline is recalling 44 PORT INSERTION PACK kits nationwide. These kits contain SafeAir Smoke Evacuation Pencil components that were previously recalled by Stryker.

    Product
    MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0095-2025·2024-12-11

    Diltiazem Hydrochloride Extended-Release Capsules Recalled for Manufacturing Impurity

    Glenmark Pharmaceuticals is recalling 25,584 bottles of Diltiazem Hydrochloride Extended-Release Capsules 120 mg nationwide due to a manufacturing impurity above FDA-recommended limits. The affected medication was distributed throughout the United States.

    Product
    DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0247-2025·2024-12-11

    Ready-meal chicken tacos recalled due to Listeria monocytogenes

    Albertsons ready-meal chicken street taco kits have been recalled due to potential Listeria monocytogenes contamination in the cooked chicken. The recall affects 2,374 units distributed across 21 U.S. states.

    Product
    (1) READY MEALS CHICKEN STREET TACOS SS COLD (UPC 27131600000) (2) READY MEALS ASADA STREET TACO MEAL SS COLD (UPC 29939100000) (3) READY MEALS CHICKEN STREET TACO MEAL SM SS COLD (UPC 27179600000)
    Category
    Food
    Distribution
    21 states
  • HighFDA (Drugs)·D-0076-2025·2024-12-11

    Levothyroxine Sodium Tablets Recalled Due to Subpotency Nationwide

    Accord Healthcare is recalling Levothyroxine Sodium 75 mcg tablets (Lot D2300191, expiring 12/31/2025) distributed nationwide due to subpotency. Affected patients should contact their healthcare provider.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0604-2025·2024-12-11

    CT imaging systems may display progressively rotated images in certain scan modes

    Certain GE Healthcare CT systems may display progressively rotated images, particularly during helical, cine, or cardiac scans. The rotation increases with each image, potentially reaching 56 degrees maximum.

    Product
    GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0106-2025·2024-12-11

    Duloxetine Delayed-Release Capsules Recalled for N-Nitroso Impurity Above Limits

    Rising Pharma is recalling 122,925 bottles of Duloxetine 30 mg capsules nationwide due to a manufacturing deviation: the presence of N-nitroso-duloxetine impurity above the recommended interim limit.

    Product
    Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0230-2025·2024-12-11

    Sysco Classic Banana Pudding Mix Recalled for Metal Fragment Contamination

    Sysco Classic Banana Instant Pudding & Pie Filling Mix is recalled due to metal fragments introduced during dextrose processing. The product was distributed to 29 states.

    Product
    Sysco Classic Banana Instant Pudding & Pie Filling Mix Natural and Artificial Flavor, NET WT. 24 OZ (1 LB 8 OZ) 680g, UPC 0 74865 11559 9, Case UPC 10074865115596, DISTRIBUTED BY SYSCO CORPORATION, HOUSTON, TEXAS 77077
    Category
    Food
    Distribution
    30 states
  • HighFDA (Devices)·Z-0577-2025·2024-12-11

    Fluoroscopic X-ray System Hand Switch May Fail and Cause Unintended Radiation

    The Ziehm Vision R fluoroscopic x-ray system has a hand switch that may fail under mechanical stress and cause unintended radiation. Ziehm Imaging, Inc. is recalling 5 affected units distributed in the U.S.

    Product
    Ziehm Vision R. Iterventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0597-2025·2024-12-11

    Siemens Atellica CI Analyzer may produce falsely elevated electrolyte test results

    Siemens' Atellica CI Analyzer may display incorrect diluent volume levels, causing falsely elevated sodium, potassium, and chloride test results in 559 units distributed worldwide.

    Product
    Atellica CI Analyzer. Catalog Numbers: 10947347.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0607-2025·2024-12-11

    GE Healthcare CT Imaging System May Produce Rotated Medical Images

    GE Healthcare CT systems may produce progressively rotated images during helical, cine, and cardiac scans. The issue affects 4 units worldwide and can cause rotations up to 56 degrees.

    Product
    GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomography system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0589-2025·2024-12-11

    BD COR GX Instrument recalled due to compromised service credentials

    Becton Dickinson recalls the BD COR GX Instrument due to unauthorized access to product service credentials. Until credentials are updated, there is a risk of unauthorized device access and potential impact to data security.

    Product
    BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990
    Category
    Medical Device
    Distribution
    Distributed nationwide