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.

301–325 of 88106

  • SevereFDA (Food)·H-0011-2027·2026-10-14

    Better Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk

    The Better Bakehouse Snack Company is recalling Donutful Chocolate Dipped Vanilla Cake Donuts due to undeclared milk. The product was distributed nationwide.

    Product
    Donutful Chocolate Dipped Vanilla Cake Donuts - 7.05oz/10ct.Case Configuration 5 count carton, 6 cartons per case. UPC 850041392103. Paperboard carton containing 5 individually wrapped packages of two donuts each. UPC: 850041392103. The Better Bakehouse Snack Co. 3651 Lindell…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0020-2027·2026-10-14

    Sweet Sensi THC Gum Drops Recalled for Staphylococcus aureus

    Sweet Sensi is recalling Passion Guava Kush THC gum drops nationwide due to the detection of Staphylococcus aureus.

    Product
    Sweet Sensi Elevated Edibles Hybrid Gum Drops - Passion Guava Kush 140mg THC. Product is packaged in sealable & flexible gold, purple and black metallic plastic mylar pouch and is sold in two sizes: 1) Net wt. Approx. 2.1oz (60g) 10 count and 2) Net wt. 6.3oz (180g) 30 count.…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0029-2027·2026-10-14

    FDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns

    Carolina Infusion, LLC is recalling Tirzepatide/Cyanocobalamin 76/2 mg/mL injectable syringes due to a lack of assurance of sterility related to formulation and processing equipment.

    Product
    TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0005-2027·2026-10-14

    K.C. Pharmaceuticals Recalls Target Eye Drops for Sterility Concerns

    K.C. Pharmaceuticals is recalling multiple brands of eye drops due to a lack of assurance of sterility. The recall covers 1,435,830 cartons distributed nationwide.

    Product
    TARGET EYE DROPS MAXIMUM REDNESS RELIEF EYE — TARGET EYE DROPS MAXIMUM REDNESS RELIEF EYE (GLYCERIN, NAPHAZOLINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0014-2027·2026-10-14

    GIAS Food Inc. Recalls Lemon Alfredo Fettuccine for Listeria Contamination

    GIAS Food Inc. is recalling 1,174 cases of Lemon Alfredo Fettuccine due to contamination with Listeria monocytogenes. The product was distributed to retail locations nationwide.

    Product
    Lemon Alfredo Fettuccine packed in a yellow plastic sealed bag with pink and black lettering; label reads in part as "bettergoods Lemon Alfredo Fettuccine, MADE IN ITALY, NET WT 22 OZ, BEST if Used By: SEP 21 2027 L6081A, UPC 194346442706, DISTRIBUTED BY: Walmart Inc.…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0079-2027·2026-10-14

    Cardinal Health Recalls Presource Packs with Medtronic Microstream Components

    Cardinal Health 200, LLC is recalling 210 Presource Packs containing Medtronic Microstream components due to reports of difficulty disconnecting the adapter, which can cause treatment delays or unintended extubation.

    Product
    Presource Packs containing Medtronic Microstream Components: Intubation Kit Catalog Numbers AN23366084 AN23366085 AN2336608H AN2336608J Intubating Bag Kit Catalog Number OMSVM4166A Intubation UH Kit Catalog Number AN2336608G
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0107-2027·2026-10-14

    Polymedco Sediplast Tubes Recalled for Potential Blood Exposure

    Polymedco is recalling Sediplast tubes because pressure buildup may eject the cap, releasing blood and creating a biological hazard for operators.

    Product
    SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0023-2027·2026-10-14

    FDA Recalls Tri-MIX Injectable Due to Sterility Concerns

    Carolina Infusion, LLC is recalling Tri-MIX injectable syringes due to a lack of assurance of sterility related to processing equipment.

    Product
    Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/10, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0085-2027·2026-10-14

    Stryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach

    Stryker is recalling Bard EP XT Decapolar Steerable Diagnostic EP Catheters due to a potential sterile barrier breach that could lead to particulate embolization, infection, or thrombus formation.

    Product
    BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0017-2027·2026-10-14

    biQ-FEL Beverage Recalled for Undeclared Sildenafil and Tadalafil

    A&P CREATIONS is recalling biQ-FEL beverage bottles containing undeclared Sildenafil and Tadalafil. The product was distributed nationwide.

    Product
    biQ-FEL, 16.9 fl oz (500 mL), 17 servings per bottle, Manufactured by ALMENAT SAS AV 39 OESTE No 10 OESTE-18 CALI VALLE INDUSTRIA COLOMBIANA; Distributed by: Biofel
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0031-2027·2026-10-14

    Carolina Infusion Recalls Tri-MIX Injectable Due to Sterility Concerns

    Carolina Infusion, LLC is recalling Tri-MIX injectable syringes due to a lack of assurance of sterility related to formulation and processing equipment.

    Product
    Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0024-2027·2026-10-14

    Saint Francis Apizza Frozen Supreme Pizza Recalled for Undeclared Soy

    Saint Francis Apizza LLC is recalling 1,920 units of Frozen Supreme Pizza due to undeclared soybean oil and soy lecithin. The product was distributed in Kentucky and Ohio.

    Product
    Saint Francis Apizza Frozen Supreme Pizza, Net Weight: 17 oz. (482g), packaged individually in vacuum-sealed plastic, UPC: 6 66186 27760 7
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0021-2027·2026-10-14

    FDA recalls injectable compounded mixture in single-use syringes

    Carolina Infusion LLC is recalling QUAD-MIX injectable compounded product nationwide due to sterility concerns.

    Product
    QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0015-2027·2026-10-14

    Frozen Cheese Pie Recalled for Undeclared Milk Allergen

    Queso Palmita GP LLC is recalling 20 packages of frozen Pastel de Queso (Cheese Pie) in Texas due to undeclared milk.

    Product
    QUESO PALMITA. Generic Name: Pastel de Queso (Cheese Pie). Intended use: Human consumption. Condition: Frozen. Shelf life or expected life: 90 days. Type of packaging: Vacuum, resealable package. Net weight: 1.2 lbs. UPC: 094922980045.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0078-2027·2026-10-14

    Philips Spectral CT Systems Recalled for Software Issues Affecting Safety

    Philips Medical Systems is recalling 539 Spectral CT systems due to software issues that may cause image artifacts, wrong slice thickness, or unintended system motion.

    Product
    Spectral CT and Spectral CT 7500 RT; Software Version Numbers: 5.2.X (U.S.); 5.0.X, 5.2.X, 5.4.X (Outside U.S.); Model Numbers: 1. 728333 (U.S. and Outside U.S.), 2. 728340 (Outside U.S.), 3. 728344 (Outside U.S.), 4. 728345 (Outside U.S.);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0022-2027·2026-10-14

    Saint Francis Apizza Frozen Cheese Pizza Recalled for Undeclared Soy

    Saint Francis Apizza LLC is recalling 4,255 units of frozen cheese pizza due to undeclared soy ingredients. The product was distributed in Kentucky and Ohio.

    Product
    Saint Francis Apizza Frozen Cheese Pizza, Net Weight: 17 oz. (482g), packaged individually in vacuum-sealed plastic, UPC: 6 66186 27759 1
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·H-0023-2027·2026-10-14

    Saint Francis Apizza Frozen Mushroom and Onion Pizza Recalled for Undeclared Soy

    Saint Francis Apizza LLC is recalling 2,655 units of frozen Mushroom & Onion Pizza in Kentucky and Ohio due to undeclared soy ingredients.

    Product
    Saint Francis Apizza Frozen Mushroom & Onion Pizza, Net Weight: 17 oz. (482g), packaged individually in vacuum-sealed plastic, UPC: 6 66186 27764 5
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·H-0027-2027·2026-10-14

    J K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg

    J K Patisserie & Bakery LLC is recalling croissants because egg was not declared in the Contains statement. The product was distributed in New York and New Jersey.

    Product
    Croissant; packaged in cardboard box; Ingredients: King Midas Special (Wheat flour, niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid, malted barley flour), Veribest Pastry flour (Wheat Flour), Unsalted Butter, Milk, Water, Granulated Sugar, Yeast, Salt, eggs…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·H-0025-2027·2026-10-14

    J K Patisserie Recalls Lemon Blueberry Loaf for Undeclared Soy

    J K Patisserie & Bakery LLC is recalling 87 units of Lemon Blueberry Loaf because the product contains undeclared soybean oil and soy lecithin.

    Product
    Lemon Blueberry Loaf packaged in a cardboard box; Ingredients: King midas flour, Veribest pastry flour, Granulated Sugar, Blueberries frozen IQF, Milk, Canola Oil, Eggs, Lemon Juice, Lemon Zest, Baking Powder, Lemon Extract, Salt; Contains: Wheat, Milk, Eggs
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·H-0021-2027·2026-10-14

    Saint Francis Apizza Frozen Pepperoni Pizza Recalled for Undeclared Soy

    Saint Francis Apizza LLC is recalling 4,931 units of frozen pepperoni pizza due to undeclared soybean oil and soy lecithin.

    Product
    Saint Francis Apizza Frozen Pepperoni Pizza, Net Weight: 17 oz. (482g), packaged individually in vacuum-sealed plastic, UPC: 6 66186 27762 1
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·H-0026-2027·2026-10-14

    J K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy

    J K Patisserie & Bakery LLC is recalling 610 units of chocolate chip cookies sold in New York and New Jersey because soy was not declared in the Contains statement.

    Product
    Chocolate Chip Cookies packaged in a cardboard box; Ingredients: King Midas Special (Wheat flour, niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid, malted barley flour), Dark Chocolate Chip (sugar, unsweetened chocolate, cocoa butter, soy lecithin, ground…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·H-0012-2027·2026-10-14

    FreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen

    FreshPoint Central Florida, Inc. is recalling 1,093 units of Cranberry Chicken Salad Wedges because the egg allergen is missing from the 'Contains' statement on the label.

    Product
    Cranberry Chicken Salad Wedge 4.5 oz package in Wedge plastic and clear container with a plastic film sealing the top.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0073-2027·2026-10-14

    Steris VERIFY Dual Species Biological Indicator Recall for Spore Population Issues

    Steris Corporation is recalling VERIFY Dual Species Self-Contained Biological Indicators because the spore population may fall below specifications, potentially leading to false sterilization results.

    Product
    VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3061
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·N/A·2026-10-14

    Beak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination

    Beak & Skiff Sanitizer Alcohol Antiseptic 80% is being recalled because FDA analysis found acetaldehyde above specification limits in the product. The recall affects bottles distributed in New York and through online sales.

    Product
    Tri-Immune Boost (Glutathione: 200 mg, Ascorbic Acid: 200 mg, Zinc: 2.5 mg), 30 mL vial, Rx only, Centric Compounding, 7447 Harwin Dr. Suite 111, Houston, TX 77036
    Category
    Drug
    Distribution
    Distributed nationwide