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.

8026–8050 of 26961

  • HighFDA (Devices)·Z-0673-2025·2024-12-18

    Medical Device Recall: PTH Assay on DxI 9000 Analyzer May Produce Inaccurate Results

    Beckman Coulter recalls an Access Intact PTH assay used on the DxI 9000 analyzer because samples stored on the device may produce falsely low hormone-level results, potentially leading to missed diagnosis or delayed treatment.

    Product
    Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0118-2025·2024-12-18

    Drug Recall: Levothyroxine Sodium Tablets Affected by Potency Failures

    Viatris Inc recalls 92,512 bottles of Levothyroxine Sodium tablets with potency failures—some are stronger than intended, others are weaker than intended.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0126-2025·2024-12-18

    Levothyroxine Sodium Tablets Recalled Due to Potency Failures

    Viatris Inc recalls 43,765 bottles of Levothyroxine Sodium 88 mcg tablets nationwide due to potency failures where some tablets are stronger and others weaker than labeled.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0135-2025·2024-12-18

    FDA Recalls Levothyroxine Sodium Tablets for Potency Variation

    Mylan Institutional recalls 690 cartons of Levothyroxine Sodium 150 mcg tablets nationwide due to potency variation. Some units may be subpotent or superpotent.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0676-2025·2024-12-18

    Philips Allura Xper X-ray Systems Prone to Clamping Bolt Failure and Collision Risk

    Philips Allura Xper radiological systems may experience propeller motor and x-ray tube locking bolt breaks, causing erratic C-arm movements with potential for collision with patients or bystanders, and unnecessary radiation exposure.

    Product
    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0121-2025·2024-12-18

    Levothyroxine Sodium Tablets recalled nationwide for potency failures

    Viatris Inc. is recalling 19,549 bottles of Levothyroxine Sodium 175 mcg tablets nationwide due to potency failures. Some tablets contain excessive active ingredient while others contain insufficient amounts.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0267-2025·2024-12-18

    Dried Cinnamon Powder Recalled for Elevated Lead Contamination

    Super Brand Dried Cinnamon Powder (4 oz) distributed across nine states is being recalled due to elevated lead levels. Consumers should discard purchased containers.

    Product
    "***SUPER***BRAND***DRIED CINNAMON POWDER***Net Wt: 4oz(113g)***PRODUCT OF CHINA***DISTRIBUTOR: IHA BEVERAGE COMMERCE, CA, 90040***"UPC#610232012476
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-0670-2025·2024-12-18

    BD Pyxis MedStation ES Automated Medication Cabinet Recalled for Software Defect

    An automated medication dispensing cabinet may open the wrong storage pocket due to a software malfunction, potentially leading to incorrect medication removal. The manufacturer is recalling affected units.

    Product
    BD Pyxis MedStation ES, REF: 323
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0116-2025·2024-12-18

    Injectable drug recalled for temperature excursion during storage

    Mckesson Medical-Surgical Inc. is recalling HYLENEX RECOMBINANT (hyaluronidase) injection due to cGMP deviations involving a temperature excursion during storage, which may have compromised drug potency.

    Product
    HYLENEX RECOMBINANT — HYLENEX RECOMBINANT (HYALURONIDASE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0117-2025·2024-12-18

    FDA Recalls JAVYGTOR Tablets Due to Failed Impurities and Degradation Specifications

    Dr. Reddy's Laboratories is recalling 7,233 bottles of JAVYGTOR (sapropterin dihydrochloride) tablets nationwide because the medication failed specifications for impurities and degradation products. Affected patients should contact their healthcare provider.

    Product
    JAVYGTOR — JAVYGTOR (SAPROPTERIN DIHYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0652-2025·2024-12-18

    ICU Medical ChemoLock Closed System Transfer Device Packaging Recall

    ICU Medical is recalling 6,000 units of ChemoLock Close Vial Spike (Model CL-80) due to incorrect packaging and labeling of finished goods. Units were distributed in Illinois and Canada.

    Product
    ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants. The Chemolock is needle free and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytoto
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0669-2025·2024-12-18

    Hologic Sizer Set Missing Instructions for Use and Sterilization

    Hologic is recalling 178 units of Sizer Set surgical instruments nationwide because instructions for use and revised sterilization instructions were not provided with the product.

    Product
    Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0113-2025·2024-12-18

    Varithena Administration Pack Recalled Due to Incorrect Syringe Connector Type

    Biocompatibles is recalling 432 Varithena (polidocanol injectable foam) Administration Packs due to incorrect syringe connectors. The packs contain luer lock syringes instead of the required luer slip connection syringes.

    Product
    Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, 2 compression pads, 1 Varithena Transfer Unit, 1 manometer tubing, Rx Only, Distributed by Biocompatibles Inc., a BTG International Group company. CN01114.3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0261-2025·2024-12-18

    Nutren 2.0 Nutritional Drink Recalled for Labeling Error

    Nestle Health Science recalls Nutren 2.0 pouches mislabeled as Isosource 1.5. The labeling error affected 5,754 units distributed across 16 states.

    Product
    Nestle Health Services Nutren 2.0 kCal/mL, Calorically Dense Complete Nutrition with Fiber Unflavored. 1000mL (1.1QT). UPC 0 43900-18181 3. Manufactured for Nestle HealthCare Nutrition, Inc., Bridgewater, NJ 08807. 6 - 1L pouches per case.
    Category
    Food
    Distribution
    16 states
  • ModerateFDA (Drugs)·D-0115-2025·2024-12-18

    OTC Cold and Flu Medication Recalled Due to Manufacturing Process Deviations

    LNK International recalls Kirkland Severe Cold & Flu Plus Congestion due to Current Good Manufacturing Practice (CGMP) deviations. The product should not have been released and was distributed to wholesale customers.

    Product
    SEVERE COLD AND FLU PLUS CONGESTION — SEVERE COLD AND FLU PLUS CONGESTION (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0651-2025·2024-12-18

    Small DKS Disposable Kerrison System Inadvertently Distributed

    Small DKS Disposable Kerrison System instrument sets were inadvertently distributed when not intended for commercial distribution. Six sets (Lot 1578) were distributed to Kansas, Louisiana, Michigan, New York, and Texas.

    Product
    Small DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Small Obturator Trocar (Model Number 330.013) 2. DKs Small Lighted Cannula (Model Number 330.014) 3. DKS Small Kerrison (330.016)
    Category
    Medical Device
    Distribution
    5 states
  • CriticalFDA (Food)·F-0248-2025·2024-12-11

    Albertsons Ready-Meal Salads Recalled for Listeria Contamination

    Albertsons Companies LLC recalls multiple ready-meal salad products due to Listeria monocytogenes contamination in cooked chicken. Products were distributed across 21 US states with sell-through dates through October 13, 2024.

    Product
    (1) GINGER CHICKEN BROCCOLI SALAD FS (UPC 27110800000) (2) READY MEALS GINGER CHICKEN BROCOLLI SALAD SS (UPC 29105700000) (3) GINGER BROCOLLI SALAD FS (UPC 29233600000) (4) CHICKEN CAESAR SALAD FS (UPC 29130700000) (5) CAESAR CHICKEN BOWL (UPC 29125500000) (6) READY MEALS CHICKEN
    Category
    Food
    Distribution
    21 states
  • SevereFDA (Food)·F-0256-2025·2024-12-11

    Fresh Express Chicken Caesar Salad Bowls Recalled for Listeria Monocytogenes

    Fresh Express Gourmet Cafe Chicken Caesar salad bowls are being recalled due to potential Listeria monocytogenes contamination linked to a Bruce Pac recall. The recall affects products distributed across multiple U.S. states.

    Product
    Fresh Express Gourmet Cafe Chicken Caesar 5.75oz, Labeled Salad Bowls, Refrigerate, UPC Code: 71279407074 and Case Code:071279565620
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Food)·F-0245-2025·2024-12-11

    Wegmans Asian Sesame Salad recalled for undeclared egg

    Wegmans Large Asian Sesame Salad with Chicken contains undeclared egg, a common allergen. The recall affects 365 units distributed across nine states.

    Product
    Wegmans Large Asian Sesame Salad with Chicken and Asian Peanut Dressing.
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Drugs)·D-0086-2025·2024-12-11

    ZapMax Capsules Recalled for Undeclared Sildenafil and Diclofenac

    ZapMax Capsules, 500 mg are recalled for containing undeclared sildenafil and diclofenac without FDA approval. The product was distributed nationwide; consumers should stop using immediately and consult their healthcare provider.

    Product
    ZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax, 2108 N St. Sacramento, CA 95816, www.zapmax.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0085-2025·2024-12-11

    ZoomMax Capsules contain undeclared sildenafil and diclofenac

    ZoomMax Capsules have been recalled by the FDA due to containing undeclared sildenafil and diclofenac. The product was marketed without FDA approval.

    Product
    ZoomMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZoomMax, 2108 N St. Sacramento, CA 95816, www.zoommax.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0257-2025·2024-12-11

    Fresh Express Salad Bowls Recalled for Potential Listeria Contamination

    Fresh Express Gourmet Cafe Santa Fe Greek salad bowls are being recalled due to potential Listeria monocytogenes contamination linked to a chicken ingredient recall. No illnesses have been reported.

    Product
    Fresh Express Gourmet Cafe Santa Fe Greek 5.2 oz, Labeled Salad Bowls, Refrigerate, UPC Code: 71279 40713 5 and Case Code :71279-56704
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Drugs)·D-0084-2025·2024-12-11

    PeakMax Capsules Recalled for Undeclared Sildenafil and Diclofenac

    PeakMax Capsules contain undeclared sildenafil and diclofenac and were marketed without FDA approval. This Class I recall affects capsules distributed nationwide.

    Product
    PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakMax, San Francisco, CA, www.PeakMax.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0083-2025·2024-12-11

    VitalityXtra Capsules Recalled for Undeclared Sildenafil and Diclofenac

    VitalityXtra Capsules containing undeclared sildenafil and diclofenac are being recalled nationwide. The product was marketed without required FDA approval and poses health risks from undeclared pharmaceutical ingredients.

    Product
    VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: VitalityXtra, San Francisco, CA www.vitalityxtra.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0255-2025·2024-12-11

    Enoki Mushrooms Recalled for Potential Listeria Contamination

    HH Fresh Trading is recalling enoki mushrooms distributed to West Virginia retail stores due to potential Listeria monocytogenes contamination. Consumers should not consume this product.

    Product
    ENOKI MUSHROOM; 200g/package (25 packages/case); vacuum packed; refrigerated "***ENOKI MUSHROOM***Net WT***200g(1.05oz)***To keep sealed & cold Product of Taiwan Distributed by: HH Fresh Trading Los Angeles CA 90063 Exported by JIA YANG INTERNATIONAL ENTERPRISES CO., LTD. Produc
    Category
    Food
    Distribution
    0 states