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.

20051–20075 of 88183

  • HighFDA (Food)·F-0432-2023·2023-03-22

    Clasen Semisweet Chocolate Drops Recalled for Undeclared Peanut

    Clasen Quality Chocolate recalled 2M Semisweet Chocolate Drops due to undeclared peanut residue. Approximately 150,600 lbs distributed across 12 states.

    Product
    2M Semisweet Chocolate Drop, Item # 53700. Net Wt. 50 lbs. (22.68 KG) poly-lined case. Ingredients: Unsweetened Chocolate, Sugar, Cocoa Butter, Dextrose, Sunflower Lecithin (an emulsifier), and Vanilla Extract. Distributed By: Clasen Quality Chocolate, 5126 West Terrace…
    Category
    Food
    Distribution
    12 states
  • HighFDA (Drugs)·D-0463-2023·2023-03-22

    Clobazam Tablets Recalled Due to Cross Contamination Risk

    Breckenridge Pharmaceutical is recalling Clobazam 20 mg tablets (Lot #5210147, exp. 12/2023) nationwide due to potential cross contamination from manufacturing deviations.

    Product
    Clobazam Tablets, 20 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037, NDC 51991-901-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0615-2023·2023-03-22

    Maple Waffle Cereal Recalled Due to Metal Contamination

    Catalina Snacks is recalling Maple Waffle flavored ready-to-eat cereal due to the potential presence of metal fragments. Consumers should not consume the affected product.

    Product
    Maple Waffle flavored ready-to-eat cereal packaged in 9oz (UPC 860479001539) plastic stand up pouch.
    Category
    Food
    Distribution
    21 states
  • HighFDA (Devices)·Z-1262-2023·2023-03-22

    da Vinci Surgical System Patient Cart Ballscrew Failure Risk

    Intuitive Surgical recalls Patient Side Carts for da Vinci X and Xi surgical systems due to ballscrew failure risk. The failure could cause uncontrolled carriage movement leading to potential tissue injury during surgery. 9 units affected.

    Product
    Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Patient Side Cart, REF: 380652, with instrument arms, used as part of the da Vinci Xi Surgical System, REF: IS4000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0612-2023·2023-03-22

    Catalina Snacks fruit cereal recalled due to metal contamination

    Catalina Snacks is recalling fruit flavored ready-to-eat cereal in 1.27 oz and 8 oz pouches due to potential metal foreign material contamination. Consumers who purchased affected products should not consume them.

    Product
    Fruit flavored ready-to-eat cereal packaged in 1.27 oz. (UPC 850017468214) and 8oz. ( UPC 850017468085) plastic stand up pouch.
    Category
    Food
    Distribution
    21 states
  • HighFDA (Devices)·Z-1241-2023·2023-03-22

    BD Insulin Syringes Recalled for Potential Nonsterile Condition

    Becton Dickinson & Company is recalling 1.17 million BD Ultra-Fine Insulin Syringes due to a nonsterile manufacturing defect that could expose patients to pathogenic microorganisms and increase infection risk.

    Product
    BD Ultra-Fine Insulin Syringe 1mL, 6mm, 31G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326678
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1222-2023·2023-03-22

    Hair Growth Laser Comb Recalled for Missing Safety Warnings and Labels

    OMM Imports' Recreo Hair Growth Laser Comb is being recalled because 1,620 units lack required safety labels, warnings, and certification documentation. Missing labels create risk for users of the Class 3R laser device.

    Product
    Recreo Hair Growth Laser Comb
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0442-2023·2023-03-22

    Chocolate wafer product recalled for undeclared peanut residue

    Clasen Quality Chocolate is recalling DF ANSA chocolate wafers because the product may contain undeclared peanut residue, posing a risk to consumers with peanut allergies.

    Product
    DF ANSA Choc Flvd Conf Wafer (MB), Item # 59154. Net Wt. 50 lbs. (22.68 KG) poly-lined case. Ingredients: Soluble Corn Fiber, Palm Kernel and Palm Oil, Allulose, Cocoa Powder (Processed with Alkali), Chocolate Liquor, Sunflower Lecithin (an emulsifier), Monk Fruit Extract.…
    Category
    Food
    Distribution
    12 states
  • HighFDA (Food)·F-0441-2023·2023-03-22

    38% Cacao Milk Chocolate Wafers Recalled for Undeclared Peanut Residue

    Clasen Quality Chocolater has recalled 38% Cacao Milk Chocolate Wafers due to undeclared peanut residue. Consumers with peanut allergies should not consume the product.

    Product
    38% Cacao Milk Chocolate Wafer (RA MB), Item # 58873. Net Wt. 50 lbs. (22.68 KG) poly-lined case. Ingredients: Sugar, Cocoa Butter, Milk, Chocolate Liquor, Sunflower Lecithin (an emulsifier), Vanilla Extract. Distributed By: Clasen Quality Chocolate, 5126 West Terrace…
    Category
    Food
    Distribution
    12 states
  • HighFDA (Devices)·Z-1259-2023·2023-03-22

    Radiation Therapy Software May Not Properly Execute Heart-Protection Breath Hold

    Brainlab ExacTrac Dynamic software used in charged-particle radiation therapy systems may not properly execute Deep Inspiration Breath Hold (DIBH) functionality, a heart-protection technique. The issue affects 56 systems across the United States.

    Product
    Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0443-2023·2023-03-22

    NGMO Ballard Semisweet Chocolate Wafer Recalled for Undeclared Peanut Residue

    Clasen Quality Chocolater is recalling NGMO Ballard Semisweet Chocolate Wafer due to possible undeclared peanut residue. Consumers with peanut allergies who may have purchased this product should not consume it.

    Product
    NGMO Ballard Semisweet Chocolate Wafer, Item # 59343. Net Wt. 50 lbs. (22.68 KG) poly-lined case. Ingredients: Chocolate Liquor (Processed with Alkali), Sugar, Cocoa Butter, Butterfat (Milk), Sunflower Lecithin (an emulsifier), Vanilla Extract. Distributed By: Clasen…
    Category
    Food
    Distribution
    12 states
  • HighFDA (Food)·F-0595-2023·2023-03-22

    Cafe' Intermezzo Cheesecake Recalled for Undeclared Hazelnut Allergen

    Epic Baking is recalling Cafe' Intermezzo Hazelnut Chocolate Cheesecake due to undeclared hazelnut sub-ingredient. The product was distributed to Georgia and Tennessee.

    Product
    Cafe' Intermezzo Hazelnut Chocolate Cheesecake 6 lbs Ingredients: Eggs, Cream Cheese, Sugar, Nutella, Cocoa Crust (Graham Crackers, Butter, Sugar, Cocoa Powder, Vanilla Extract), Vanilla Extract, Corn Starch. Contains: Milk, eggs, tree nuts, wheat and soy. May contain peanuts.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1256-2023·2023-03-22

    Ambulance cot may separate due to insufficient epoxy in assemblies

    Stryker's Power-PRO 2 ambulance cots may separate at head or foot due to insufficient epoxy. Four affected units in NY and VA should be removed from service immediately.

    Product
    Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location. Model: 650705550001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1260-2023·2023-03-22

    Bard Mission Disposable Core Biopsy Instrument Kit Recall: Sizing Incompatibility

    Bard Peripheral Vascular is recalling certain Bard Mission Disposable Core Biopsy Instrument Kits due to sizing incompatibility between the biopsy instrument and coaxial needle, which could cause procedural delays or needle breakage.

    Product
    Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1238-2023·2023-03-22

    BD Insulin Syringes Recalled Due to Nonsterile Condition

    BD Insulin Syringes (Catalog 329420) are being recalled due to nonsterile conditions that could expose patients to pathogenic microorganisms and increase infection risk. The recall affects 961,000 units distributed worldwide.

    Product
    BD Insulin Syringes with the BD Micro-Fine TM IV Needle 1ml, 12.7mm, 28G Single Unit Scale. Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 329420
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0605-2023·2023-03-22

    Cheesecake Recalled for Undisclosed Almond Allergen on Label

    Epic Baking recalls Cafe' Intermezzo Amaretto Cheesecakes because the label fails to disclose almonds in the ingredient list despite containing almonds. The label only states 'may contain tree nuts.'

    Product
    Cafe' Intermezzo White Chocolate Amaretto Cheesecake 7 lbs Ingredients: Eggs, Cream Cheese, Sugar, Amaretto Syrup, Whipped Cream, Almond Crust (Graham Crackers, Butter, Sugar, Almonds, Vanilla Extract), Vanilla Extract, White Chocolate, Almond Extract, Corn Starch. Contains…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0610-2023·2023-03-22

    Soybean Lecithin Powder Recalled for Undeclared Peanut Allergen

    Navada Imports is recalling 575 cases of soybean lecithin powder due to undeclared peanut allergen. Affected products were distributed nationwide to manufacturers.

    Product
    Soybean Lecithin Powder Packaged in 44 lb. (20 kg.) boxes
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0607-2023·2023-03-22

    Sunflower Lecithin Powder Recalled for Undeclared Peanut Allergen

    Navada Imports is recalling sunflower lecithin powder in 44 lb. boxes due to an undeclared peanut allergen. The affected product poses a serious risk to consumers with peanut allergies.

    Product
    Sunflower Lecithin Powder Packaged in 44 lb. (20 kg.) boxes
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1251-2023·2023-03-22

    BioFire BCID2 Diagnostic Panels Recalled for Temperature-Related Performance Issues

    BioFire Diagnostics is recalling BioFire BCID2 diagnostic panels that experienced temperature excursions during shipment, which may reduce their performance. Affected kits were distributed in Florida and Georgia.

    Product
    In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0462-2023·2023-03-22

    Clobazam tablets recalled for potential manufacturing cross-contamination risk

    Breckenridge Pharmaceuticals is recalling certain lots of Clobazam 10 mg tablets due to a potential cross-contamination risk stemming from manufacturing process deviations.

    Product
    Clobazam Tablets, 10 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037, NDC 51991-900-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0600-2023·2023-03-22

    Red Velvet Torte Recalled for Undeclared Food Coloring

    Epic Baking's Cafe' Intermezzo Red Velvet Torte is recalled due to undeclared Red 40 food coloring. The recall affects 279 tortes distributed to Georgia and Tennessee.

    Product
    Cafe' Intermezzo Red Velvet Torte 5.5 lbs Ingredients: Red Velvet Cake, Water, Vegetable Oil, Cream Cheese Frosting (Cream Cheese, Sugar, Butter, Shortening, Vanilla Extract), Chocolate Pudding Mix. Contains: Milk, eggs, wheat, and soy, May contain tree nuts and peanuts.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0592-2023·2023-03-22

    Café Intermezzo Chocolate Raspberry Torte Recalled for Undeclared Red 40

    Epic Baking is recalling Café Intermezzo Chocolate Raspberry Torte products because they contain undeclared Red 40, a color additive. The affected products were distributed in Georgia and Tennessee.

    Product
    Cafe' Intermezzo Chocolate Raspberry Torte Net Weight 6.13 lbs Ingredient: Dark Chocolate Cake, Water, Vegetable Oil, Coffee, Raspberry Preserves, Chocolate Pudding Mix, Chocolate Buttercream Frosting (Sugar, Shortening, Milk, Cocoa Powder, Vanilla Extract, Salt). Contains…
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0427-2023·2023-03-22

    White Chocolate Wafer Recalled for Undeclared Peanut Residue

    Clasen Quality Chocolate is recalling DF FT Simple Free White Wafer (Item #12935) due to undeclared peanut residue. Consumers with peanut allergies should avoid this product.

    Product
    DF FT Simple Free White Wafer (MB), Item # 12935. Net Wt. 50 lbs. (22.68 KG) poly-lined case. Ingredients: Sugar, Palm Kernal Oil, Natural Flavor, Sunflower Lecithin (an emulsifier), and Salt. Distributed By: Clasen Quality Chocolate, 5126 West Terrace Drive, Madison, WI…
    Category
    Food
    Distribution
    12 states
  • ModerateFDA (Food)·F-0596-2023·2023-03-22

    Lemon Torte Recall: Undeclared Food Colorants in Product

    Epic Baking's Cafe' Intermezzo Heavenly Lemon Torte contains undeclared food colorants (Yellow 5, Yellow 6, and Red 40) not listed on the label. The product was distributed in Georgia and Tennessee.

    Product
    Cafe' Intermezzo Heavenly Lemon Torte 6lbs Ingredients: Yellow Cake, Water, Vegetable Oil, Lemon Buttercream Frosting (Sugar, Shortening, Lemon Jell-O, Vanilla Extract, Lemon Emulsion, Lemon Extract, Salt, Yellow Food Color), Lemon Juice, Lemon Gelatin, Lemon Curd, Lemon Cream…
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0590-2023·2023-03-22

    Cheesecake Brownie Recalled for Undeclared Artificial Food Colorants

    Epic Baking's Cafe' Intermezzo Chocolate Candy Brownie Cheesecake was recalled for containing undeclared artificial food colorants. Approximately 98 units were distributed to Georgia and Tennessee.

    Product
    Cafe' Intermezzo Chocolate Candy Brownie Cheesecake 6.5 lbs Ingredients: Cream Cheese, Eggs, Sugar, Brownie Batter, Pretzel Graham Cracker Crust (Graham Cracker Crumbs, Butter, Sugar, Pretzels, Cocoa Powder, Vanilla Extract), Chocolate Ganache (Chocolate Chips, Heavy Cream), M&M…
    Category
    Food
    Distribution
    2 states