The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

13901–13925 of 53090

  • HighFDA (Food)·F-0608-2023·2023-03-22

    Sunflower Lecithin Liquid Products Recalled for Undeclared Peanut Allergen

    Navada Imports is recalling sunflower lecithin liquid in bulk totes due to undeclared peanut allergen. The affected products were distributed nationwide to food manufacturers.

    Product
    Sunflower Lecithin Liquid Packaged in 2,200 lb. (1,000 kg.) totes
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0617-2023·2023-03-22

    Creamy Ranch Snack Mix Recalled for Metal Contamination

    Catalina Snacks recalls Creamy Ranch flavored snack mix due to metal contamination. Consumers who have this product should not eat it.

    Product
    Creamy Ranch flavored ready-to-eat snack mix packaged in 6oz (UPC 850017468160) plastic stand up pouch.
    Category
    Food
    Distribution
    21 states
  • HighFDA (Drugs)·D-0458-2023·2023-03-22

    Alprazolam Tablets Recalled for Potential Cross-Contamination Risk

    Breckenridge Pharmaceuticals is recalling Alprazolam Tablets, USP 0.25mg distributed nationwide due to a potential cross-contamination risk from manufacturing deviations.

    Product
    Alprazolam Tablets, USP, 0.25mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0704-01), b) 500-count bottle and c) 1,000-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc.…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0584-2023·2023-03-22

    Bakery Torte Recalled for Undeclared Espresso and Food Dyes

    Epic Baking recalls Café Intermezzo Amaretto White Chocolate Tortes due to undeclared sub-ingredients: espresso, Yellow 5, and Yellow 6. These ingredients pose a risk to consumers with sensitivities.

    Product
    Cafe' Intermezzo Amaretto White Chocolate Torte 6.37 lbs Ingredient: White cake mix, vegetable oil, Amaretto syrup, Almond Extract, White chocolate flavor, Icing (Butter, Sugar, Amaretto syrup, Almond Extract, Vanilla Extract, white chocolate), Contains: Milk, eggs, wheat, soy…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0507-2023·2023-03-22

    Bistro To Go Yogurt Parfait Recalled for Listeria Contamination

    Fresh Creative Cuisine is recalling Bistro To Go Strawberry Low Fat Yogurt Parfait cups sold in January 2023 due to potential Listeria monocytogenes contamination. No illnesses have been reported.

    Product
    Bistro To Go, Strawberry Low Fat Yogurt, Fruit & Granola Parfait, Net Wt. 5.5 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-0076-2024·2023-03-22

    Chocolate Pudding Delight Recalled for Potential Listeria Contamination

    Quick & Fresh Chocolate Pudding Delight products sold January 24-30, 2023 are being recalled for potential Listeria monocytogenes contamination with no reported illnesses. Affected units were distributed to multiple Mid-Atlantic and Eastern states.

    Product
    Quick & Fresh, Chocolate Pudding Delight, Net Wt. 6.5 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-0597-2023·2023-03-22

    Key Lime Cheesecake recalled for undeclared food dyes

    Epic Baking is recalling Key Lime Cheesecake containing undeclared Yellow 5 and Blue 1 food dyes distributed to Georgia and Tennessee. Consumers with sensitivities may experience adverse reactions.

    Product
    Cafe' Intermezzo Key Lime Cheesecake 6.5 lbs Ingredients: Cream Cheese, Eggs, Sugar, Key Lime Mixture, Whipped Cream, Graham Cracker Crust (Graham Cracker Crumbs, Butter, Sugar, Vanilla Extract, Cinnamon), Key Lime Glaze (All-Purpose Flour, Nelly's Key Lime Juice, Vanilla…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1242-2023·2023-03-22

    BD Insulin Syringes Recalled for Nonsterile Condition and Infection Risk

    Becton Dickinson is recalling 686,500 units of BD insulin syringes due to a nonsterile condition that may expose patients to pathogenic microorganisms and risk of infection.

    Product
    BD Insulin Syringes with the BD Micro-Fine IV Needle 0.5ml, 12.7mm, 28G Single Unit Scale-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 329461
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1247-2023·2023-03-22

    TFN-Advanced Femoral Nails May Have Incorrect Length Markings

    Synthes TFN-Advanced Femoral Nails labeled as 200mm may measure 170mm, and vice versa. Healthcare providers should verify actual dimensions before surgical use.

    Product
    TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.212S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0469-2023·2023-03-22

    Eye allergy medication recalled for out-of-specification impurity

    Teva Pharmaceuticals is recalling 715,632 bottles of Clear Eyes Once Daily eye drops due to an out-of-specification impurity found during stability testing.

    Product
    Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophthalmic solution, USP, 0.2%, Antihistamine, 2.5 mL (0.085 fl oz) bottle, Sterile, Distributed by Medtech Products Inc. Tarrytown, NY 10591, A Prestige Consumer Healthcare company, Made in Israel, UPC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1243-2023·2023-03-22

    BD Ultra-Fine Insulin Syringes Recalled Due to Nonsterile Condition

    Becton Dickinson is recalling BD Ultra-Fine Insulin Syringes (Catalog Number 326719) due to a nonsterile condition that could expose patients to pathogenic microorganisms and local infection. Approximately 80,500 units distributed worldwide are affected.

    Product
    BD Ultra-Fine Insulin Syringe 1mL, 12.7mm, 29G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326719
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0423-2023·2023-03-22

    Sheetz M.T.go Turkey Deli Sandwich recalled for undeclared sesame allergen

    Sheetz Distribution Services is recalling 10,361 M.T.go Turkey Deli Sandwiches due to undeclared sesame. Consumers with sesame allergies face potential serious allergic reactions.

    Product
    Sheetz M.T.go! Made To Go Turkey Deli Sandwich. The products are packaged in 4.75 oz. clear, plastic clamshells with the following UPC 759465001854 (Turkey).
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1245-2023·2023-03-22

    Fusion Bioline Vascular Graft recalled due to manufacturing straightness defect

    Maquet Cardiovascular is recalling one Fusion Bioline Vascular Graft from lot 25162546 that failed straightness testing. The graft could reduce blood flow or cause tension, potentially leading to bleeding and pseudo-aneurysm.

    Product
    Fusion Bioline Vascular Graft, Part number M00201503046B0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0435-2023·2023-03-22

    White Confectionery Chocolate Drop May Contain Undeclared Peanut Residue

    Clasen Quality Chocolater is recalling 4M White Confectionery Drop MB chocolate because it may contain undeclared peanut residue. Peanut allergen poses a risk to consumers with peanut allergies.

    Product
    4M White Confectionery Drop MB, Item # 56464. Net Wt. 50 lbs. (22.68 KG) poly-lined case. Ingredients: Sugar, Palm Kernel Oil, Nonfat Dry Milk, Whole Milk Powder, Whey Powder (Milk) Palm Oil, Sunflower Lecithin (an emulsifier), Vanilla Extract. Distributed By: Clasen…
    Category
    Food
    Distribution
    12 states
  • HighFDA (Devices)·Z-1258-2023·2023-03-22

    Dimension Tacrolimus Diagnostic Cartridge Recalled for Measurement Imprecision

    Siemens is recalling Dimension Tacrolimus diagnostic test cartridges (lots GA2286, GA3047, GA3171) due to confirmed measurement imprecision that could lead to incorrect drug dosing and potential organ failure or toxicity.

    Product
    Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement of tacrolimus in human whole blood on the Dimension¿ clinical chemistry system SMN: 10700795 (DF207)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0035-2024·2023-03-22

    Orchard Bistro Asian Style Noodle Bowl Recalled for Listeria

    Orchard Bistro Asian Style Noodle Bowls sold January 24-30, 2023 are recalled for potential Listeria monocytogenes contamination. Products were distributed across 11 states.

    Product
    Orchard Bistro, Asian Style Noodle Bowl, Net Wt. 12 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-0527-2023·2023-03-22

    Fresh Creative Cuisine Chicken Salad Sandwiches Recalled for Listeria Risk

    Fresh Creative Cuisine chicken salad finger sandwiches sold January 24–30, 2023 are recalled due to potential Listeria monocytogenes contamination. The product was distributed to 11 states.

    Product
    Fresh Creative Cuisine, Chicken Salad Finger Sandwiches, Net . Wt. 6.5 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-0429-2023·2023-03-22

    Milk Chocolate Wafers Recalled for Undeclared Peanut Residue

    Clasen Quality Chocolate is recalling milk chocolate confectionery wafers due to potential undeclared peanut residue. Consumers with peanut allergies should not consume this product.

    Product
    Milk Choc Flvd Confectionery Wafer (HP, NSA), Item # 52546. Net Wt. 40 lbs. (18.14 KG) poly-lined case. Ingredients: Palm Kernal Oil, Whey Protein Isolate, Erythritol, Sodium Caseinate, Cocoa Powder (Processed with Alkali), Natural Flavor, Sunflower Lecithin (an emulsifier)…
    Category
    Food
    Distribution
    12 states
  • HighFDA (Devices)·Z-1257-2023·2023-03-22

    Beckman Coulter Access Immunoassay Analyzers Recalled for Defective Nut Bands

    Beckman Coulter is recalling approximately 4,100 laboratory immunoassay analyzers due to defective nut bands that may cause operational failures and erroneous patient test results.

    Product
    Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1237-2023·2023-03-22

    BD Ultra-Fine Insulin Syringe Recall Due to Nonsterile Manufacturing

    Becton Dickinson is recalling 45,000 units of BD Ultra-Fine Insulin Syringes (catalog 326679, lot 2164338) due to nonsterile manufacturing that could expose patients to pathogenic microorganisms and local infection. Distribution was worldwide.

    Product
    BD Ultra-Fine Insulin Syringe 0.5mL, 6mm, 31G - Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326679
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0621-2023·2023-03-22

    Frozen Wonton Wrappers Recalled Due to Peanut Contamination in Sub-Ingredient

    Bailey International Foods is recalling 4" x 4" and 3.5" x 3.5" frozen wonton wrappers due to peanut contamination in a sub-ingredient. The product was distributed to wholesalers in 19 states.

    Product
    Wonton wrappers, 4" x 4" and 3.5" x 3.5", packaged in 30lb. corrugated (cardboard) boxes. Product is sold frozen.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-1248-2023·2023-03-22

    TFN Femoral Nails dimensions mislabeled, may measure 170mm or 200mm

    Synthes recalled TFN-Advanced Femoral Nails because some units have incorrect dimensions: nails labeled 200mm may measure 170mm, while those labeled 170mm may measure 200mm. This dimensional mismatch could compromise surgical fixation.

    Product
    TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures Part Number: 04.037.242S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0438-2023·2023-03-22

    Chocolate Baking Chips Recalled Due to Undeclared Peanut Residue

    Clasen Quality Chocolater has recalled 4M DF NSA Semisweet Baking Drop chocolate due to potential undeclared peanut residue. The product may pose a risk to consumers with peanut allergies.

    Product
    4M DF NSA Semisweet Baking Drop (FT), Item # 56854. Net Wt. 40 lbs. (18.14 KG) poly-lined case. Ingredients: Chocolate Liquor, Inulin, Erythritol, Cocoa Butter, Sunflower Lecithin (an emulsifier), Vanilla Extract, Stevia Leaf Reb M. Distributed By: Clasen Quality…
    Category
    Food
    Distribution
    12 states
  • HighFDA (Food)·F-0618-2023·2023-03-22

    Spicy Kick snack mix recalled due to potential metal contamination

    Catalina Snacks is recalling Spicy Kick ready-to-eat snack mix pouches due to potential metal contamination. The product was distributed across multiple U.S. states and online sales.

    Product
    Spicy Kick flavored ready-to-eat snack mix packaged in 6oz (UPC 850017468153) plastic stand up pouch.
    Category
    Food
    Distribution
    21 states
  • HighFDA (Food)·F-0611-2023·2023-03-22

    Danone YoCrunch Vanilla Yogurt recalled for undeclared wheat allergen

    Danone US LLC is recalling YoCrunch Vanilla Lowfat Yogurt because the product contains undeclared wheat, which poses a risk to consumers with wheat allergies.

    Product
    YoCrunch Vanilla Lowfat Yogurt with M&Ms 6 oz (170g) UPC 046675000792 packaged in plastic cup with self-contained plastic dome attached on top, 12 cups per case
    Category
    Food
    Distribution
    5 states