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.

9876–9900 of 88183

  • SevereFDA (Food)·F-0277-2025·2024-12-18

    Organic Vegetable Medley Recalled for Potential E. Coli O121 Contamination

    4 Earth Farms is recalling Organic Vegetable Medley packages due to potential contamination with E. coli O121:H19. The affected products were distributed across multiple states to distribution centers and retailers.

    Product
    Organic Vegetable Medley; Broccoli, Cauliflower, & Carrots. Washed and ready to prepare; Perishable keep refrigerated. NET WT 12 OZ (340g) (6 pack/case) DISTRIBUTED BY: UNFI, Providence, RI 02908 USA
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·F-0268-2025·2024-12-18

    Sysco Whole and Cut Cucumbers recalled due to Salmonella contamination risk

    Sysco Corporation is recalling whole and cut cucumbers distributed in the Midwest and Canada due to potential Salmonella contamination.

    Product
    Whole and Cut Cucumbers packaged in the following sizes: 1. Select 40-45 lb. boxes Item 05000. 2. Bix 1/5 lb. Item 05023. 3. Bix Cucumber Dice 1/34" Skin-On 1/5 lb. Item 11861. 4. Bix Cucumber Dice 1/4" Seedless Skin-On. Item 11870. 5. Bix Cucumber Dice 1/2"…
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0274-2025·2024-12-18

    Vegetable Medley Recalled for Potential E. coli O121:H19 Contamination

    4 Earth Farms is recalling Vegetable Medley due to potential contamination with E. coli O121:H19. Approximately 6,036 cases were distributed across multiple states.

    Product
    Vegetable Medley; Broccoli, Cauliflower, Carrots. Washed and ready to prepare; Perishable keep refrigerated. NET WT 12 OZ (340g) (6 pack/case) DISTRIBUTED BY: Walmart Inc., Bentonville, AR 78716
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·F-0269-2025·2024-12-18

    Cucumber Chunk & Tomato Wedge Recalled for Salmonella Risk

    Sysco Corporation is recalling Cucumber Chunk & Tomato Wedge products due to potential Salmonella contamination in cucumbers. Products were distributed in Iowa, Minnesota, South Dakota, North Dakota, Wisconsin, and Canada.

    Product
    Cucumber Chunk & Tomato Wedge Item 11835. 2/2.5 lb. Keep Refrigerated
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0275-2025·2024-12-18

    Stir Fry Medley Vegetables Recalled for E. coli O121:H19 Contamination

    4 Earth Farms Stir Fry Medley vegetables are being recalled due to potential E. coli O121:H19 contamination. The affected product was distributed to retailers across multiple states; consumers should not eat the product and should discard it.

    Product
    Stir Fry Medley; Carrots, Broccoli, Broccoli Stem, Stem. Washed and ready to prepare; Perishable keep refrigerated. NET WT 12 OZ (340g) (6 pack/case) DISTRIBUTED BY: Walmart Inc., Bentonville, AR 78716
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·F-0273-2025·2024-12-18

    Vegetable Medley Recalled for Potential E. coli Contamination

    4 Earth Farms is recalling its 32-oz Vegetable Medley product distributed by Walmart due to potential contamination with E. coli O121:H19. The product was distributed to retail locations across multiple states.

    Product
    Vegetable Medley; Broccoli, Cauliflower, Carrots. Washed and ready to prepare; Perishable keep refrigerated. NET WT 32 OZ (2 LB) 907g DISTRIBUTED BY: Walmart Inc., Bentonville, AR 78716
    Category
    Food
    Distribution
    8 states
  • HighFDA (Drugs)·D-0130-2025·2024-12-18

    Prescription drug Dabigatran Etexilate recalled for elevated nitrosamine impurity

    Ascend Laboratories is recalling Dabigatran Etexilate 150mg capsules due to elevated N-nitroso-Dabigatran impurity from a manufacturing deviation. Affected lots were distributed nationwide; consult your physician before making changes to your medication.

    Product
    DABIGATRAN ETEXILATE — DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0283-2025·2024-12-18

    Hungryroot Ricotta Stuffed Shells Recalled for Potential Listeria Contamination

    Hungryroot Ricotta Stuffed Shells are being recalled due to potential contamination with Listeria monocytogenes. Affected products have been distributed in multiple states.

    Product
    Hungryroot Ricotta Stuffed Shells, 6 packs of 14 oz. each, plastic trays
    Category
    Food
    Distribution
    6 states
  • HighFDA (Drugs)·D-0114-2025·2024-12-18

    Ophthalmic Eye Drops Recalled for Defective Container Cap Spike

    FDC Limited is recalling Timolol Maleate eye drops (0.25%, 15mL bottles) due to a defective cap design where the spike may lodge in the bottle nozzle, preventing patients from dispensing the medication.

    Product
    TIMOLOL MALEATE — TIMOLOL MALEATE (TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-0263-2025·2024-12-18

    Sweet Sam's Chocolate Chunk Brownies Recalled for Undeclared Soy

    Sweet Sam's Baking Company is recalling 10,164 units of Individually Wrapped Chocolate Chunk Brownies due to undeclared soy lecithin, a major allergen. Consumers with soy allergies face a potential health risk from this labeling oversight.

    Product
    Sweet Sam's Individually Wrapped Chocolate Chunk Brownie 12- pack Individually Wrapped 3.2 oz Chocolate Chunk Brownies
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0677-2025·2024-12-18

    DiaSorin LIAISON Device Recall: Loose Caps May Cause Incorrect Patient Test Results

    DiaSorin Inc. is recalling over 21,900 LIAISON Q.S.E.T. Device Plus units worldwide due to loose caps that may leak buffer, potentially resulting in incorrect stool sample test results.

    Product
    DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
    Category
    Medical Device
    Distribution
    0 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-0128-2025·2024-12-18

    Levothyroxine Sodium Tablets Recalled Due to Potency Failures

    Viatris Inc is recalling 35,883 bottles of Levothyroxine Sodium Tablets (112 mcg) distributed nationwide due to potency failures. Some tablets contain too much active ingredient (superpotent) and others too little (subpotent). No illnesses have been reported.

    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0678-2025·2024-12-18

    Hermes Medical Imaging Software May Cause Incorrect Image Reconstruction

    Hermes Medical Solutions is recalling Hybrid Recon software (versions 4.0.0x and 5.0.0) due to a potential software configuration issue that may cause incorrect alignment during SPECT/CT image reconstruction. The issue affects 778 systems in the U.S. and internationally.

    Product
    Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0675-2025·2024-12-18

    Cardinal Health isolation gowns recalled for failing hydrostatic pressure standards

    Cardinal Health is recalling 940,203 SMS Elastic Cuff Thumbhook Level 3 Isolation Gowns because the raw materials may fail hydrostatic pressure specifications, preventing them from meeting required AAMI Level 3 protection standards.

    Product
    Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2XL, AT6588-BD, AT6588-XL, AT6688-2XL, AT6688-BD, and AT6688-XL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0259-2025·2024-12-18

    Fresh Gourmet Tortilla Strips Recalled for Undeclared Wheat

    Fresh Gourmet tortilla strips are recalled due to undeclared wheat found in crispy onion pieces mixed into the product. Consumers with wheat allergies are at risk.

    Product
    Fresh Gourmet TORTILLA STRIPS SANTA FE SYTLE NET WT 3.5 OZ (99g) UPC 7 87359 17504 6 DISTRIBUTED BY: FRESH GOURMET CO. WESTLAKE VILLAGE, CA 91361
    Category
    Food
    Distribution
    22 states
  • 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-0664-2025·2024-12-18

    MICRO-X Rover Mobile X-ray System Exposure Timing Defect Recalled

    Micro-X Ltd. is recalling five MICRO-X Rover Mobile X-ray Systems due to a timing defect that prevents adequate X-ray exposures. The 4 millisecond exposure time does not allow sufficient tolerance for diagnostic-quality imaging.

    Product
    MICRO-X Rover Mobile X-ray System, # MXU-RV35
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0136-2025·2024-12-18

    Levothyroxine Sodium Tablets Recalled for Subpotent and Superpotent Content

    Mylan Institutional is recalling Levothyroxine Sodium tablets nationwide due to subpotent and superpotent units. Patients taking affected tablets may receive incorrect doses of this thyroid medication.

    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 (Food)·F-0266-2025·2024-12-18

    Giant Eagle Butter Pecan Ice Cream Recalled for Undeclared Soy

    Giant Eagle churned Butter Pecan Reduced Fat ice cream is being recalled because it contains undeclared soy (soy lecithin), posing a risk to consumers with soy allergies.

    Product
    Giant Eagle churned Butter Pecan Reduced Fat 48FLOZ, UPC 030034940430; 6 retail units per case
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0671-2025·2024-12-18

    Automated Dispensing Cabinet Software Flaw May Cause Medication Dispensing Errors

    The BD Pyxis MedStation ES automated dispensing cabinet may dispense the wrong medication due to a software issue, potentially causing medication errors and inventory shortages.

    Product
    BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324
    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
  • HighFDA (Drugs)·D-0122-2025·2024-12-18

    Levothyroxine Sodium Tablets Recalled Due to Potency Failures

    Viatris Inc. is recalling Levothyroxine Sodium 200 mcg tablets nationwide due to potency failures—some tablets are superpotent while others are subpotent. Affected lots expire July 2025; patients should contact their healthcare provider.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide