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.

27076–27100 of 50462

  • HighFDA (Drugs)·D-0165-2019·2018-11-07

    Pharm D Solutions Recalls Levocarnitine Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling Levocarnitine 170 mg/mL Injectable because the product lacks assurance of sterility. The recall covers 3,000 milliliters distributed nationwide.

    Product
    Levocarnitine 170 mg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1617-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0332-2019·2018-11-07

    Buddy's Kitchen Recalls Huevos Rancheros Benedict Due to Listeria Risk

    Buddy's Kitchen is recalling Huevos Rancheros Style Benedict products due to potential Listeria or Salmonella contamination linked to a McCain Foods recall.

    Product
    Huevos Rancheros Style Benedict with Seasoned Black Beans, Item 70614. Net Weight 9.60 lbs. 24-6.40 oz. portions. Keep Frozen. For institutional use only. Buddy's Kitchen, Inc., Burnsville, MN 55337
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-0340-2019·2018-11-07

    Karlsburger Kitchens Roasted Onion Base Recalled for Listeria and Salmonella Risk

    Karlsburger Foods is recalling Roasted Onion Base due to potential Listeria monocytogenes and Salmonella contamination.

    Product
    Karlsburger Kitchens Roasted Onion Base, item # 23650, Net Weight 50 lbs (22.68 kg), UPC 60492-23650. Karlsburger Foods, Inc., Monticello, MN 55362
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0330-2019·2018-11-07

    Kwik Trip Recalls 4 Cheese Margherita Pizza Due to Listeria Risk

    Kwik Trip is recalling 4 Cheese Margherita Pizza due to potential contamination with Listeria or Salmonella. The recall affects 57,981 units distributed in Iowa, Minnesota, and Wisconsin.

    Product
    Kitchen Cravings Wood Fired Crust 4 Cheese Margherita Pizza, Net Wt. 28.39 oz (1 lb. 12.3 oz.) 804g. UPC 39779-00073. Produced & Distributed by Kwik Trip Inc., Lacrosse WI 54603
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-0190-2019·2018-11-07

    Pharm D Solutions Recalls Tri-Mix XL Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling 553 vials of Tri-Mix XL injectable and powder nationwide due to a lack of assurance of sterility.

    Product
    Tri-Mix XL 150 mg/10 mg/100 mcg a) Injectable NDC 69699-1353-10; b) (LYO) Powder NDC 69699-1353-10, Pharm D Solutions, Houston, Texas
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0302-2019·2018-11-07

    Philips Recalls Vereos PET/CT Software Due to Image Errors

    Philips Medical Systems is recalling 61 units of Vereos PET/CT software version 2.0.1 due to errors that may produce incorrect images or disrupt procedures.

    Product
    Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usage: The Philips Vereos PET/CT system is a diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0074-2019·2018-11-07

    Lone Star Bakery Recalls Veggie Pie Due to Foreign Object Risk

    Lone Star Bakery is recalling Veggie Pie products because they may contain a foreign object. The recall affects specific lots distributed in five states.

    Product
    Veggie Pie packaged in a paper carton, Net Wt 6 OZ, Keep Frozen
    Category
    Food
    Distribution
    5 states
  • HighFDA (Drugs)·D-0156-2019·2018-11-07

    Pharm D Solutions Recalls HCG Lyophilized Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling 2,219 vials of HCG Lyophilized 5000 IU Injectable because the product lacks assurance of sterility.

    Product
    HCG Lyophilized 5000 IU Injectable Pharm D Solutions, Houston, Texas ---- NDC 69699-1707-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0308-2019·2018-11-07

    Philips Ingenuity CT Software Recall for Misleading Calcium Score Reports

    Philips is recalling Ingenuity CT scanners with software version 4.1.6 because the Calcium Score report may display confusing information, potentially leading to patient mistreatment.

    Product
    Ingenuity CT (Model No. 728326), software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0353-2019·2018-11-07

    Vosges Haut-Chocolat Caramels et Chocolats Recalled for Wheat Labeling Error

    Vosges Haut-Chocolat is recalling Caramels et Chocolats because the outer packaging fails to declare wheat, although the inner packaging does.

    Product
    Caramels et Chocolats. Each retail tube contains four varieties on chocolate bonbons. Net wt per tube 3.8 oz.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0199-2019·2018-11-07

    Pharm D Solutions Recalls Trimix Powder Due to Sterility Concerns

    Pharm D Solutions is recalling 715 vials of Trimix powder nationwide due to a lack of assurance of sterility.

    Product
    Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/10 mcg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1365-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0335-2019·2018-11-07

    Buddy's Kitchen Recalls Frozen Stir Fry Wraps Due to Contamination Risk

    Buddy's Kitchen is recalling frozen Stir Fry Wrap with Rice, Broccoli & Peppers due to potential Listeria or Salmonella contamination linked to a McCain Foods recall.

    Product
    Stir Fry Wrap with Rice, Broccoli & Peppers, Item 70668. Net Weight 17.50 lbs. 56 - 5.00 oz. portions. Keep Frozen. For institutional use only. Buddy's Kitchen, Inc., Burnsville, MN 55337
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-0312-2019·2018-11-07

    BD Max Instrument Reader Spare Part Recalled for False Positive Results

    Becton Dickinson is recalling 23 BD Max Instrument Reader Spare Parts due to a confirmed trend of false positive Candida glabrata results.

    Product
    BD Max Instrument Reader Spare Part, Catalog Number 8090369/443364, 44336409 (Repaired Reader spare part) - Product Usage: The BD MAX System, used in conjunction with appropriate extraction kits and reagents, is capable of automated extraction and purification of nucleic acids…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0354-2019·2018-11-07

    Caito Foods Recalls Southwest Crimini Stuffed Mushrooms Due to Contamination Risk

    Caito Foods LLC is recalling 244 units of Southwest Crimini Stuffed Mushrooms due to potential contamination with Listeria monocytogenes or Salmonella.

    Product
    SOUTHWEST CRIMINI STUFFED MUSHROOM; 7oz. Black Foam Over-wrapped Trays; Keep Refrigerated; UPC 0081851202683
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0295-2019·2018-11-07

    Arthrex Recalls Li-ion Battery Housings for AR-400 DrillSaw Sports 400 System

    Arthrex, Inc. is recalling 335 Li-ion Battery Housings for the AR-400 DrillSaw Sports 400 System because they may not provide a complete seal, allowing for potential fluid ingress.

    Product
    Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage: The battery housing is used to house the battery that powers the AR-400 DrillSaw Sports 400 device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0285-2019·2018-11-07

    Magellan LeadCare II Blood Lead Test Kit Recalled for Calibration Defect

    Magellan Diagnostics is recalling LeadCare II Blood Lead Test Kits because a calibration defect causes all patient results to display as HIGH.

    Product
    Magellan LeadCare¿ II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood. Catalog Number: 70-6762 Primary DI No: 00850355006000 The LeadCare II Blood Lead Test Kit is for in vitro diagnostic use only. The test kit is for the quantitative…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0122-2019·2018-11-07

    Sprayology Recalls ImmunoBooster Homeopathic Oral Spray Due to CGMP Deviations

    Sprayology is recalling 2,837 bottles of ImmunoBooster Homeopathic Oral Spray nationwide due to manufacturing conditions that could result in microbial contamination.

    Product
    ImmunoBooster, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0038-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0309-2019·2018-11-07

    Philips CT Scanner Software Recall for Misleading Calcium Score Reports

    Philips is recalling Ingenuity Core CT scanners with software version 4.1.6 because the Calcium Score report may display confusing plaque analyses, potentially leading to patient mistreatment.

    Product
    Ingenuity Core (Model No. 728321), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0113-2019·2018-11-07

    Sprayology Recalls DigestivEase Homeopathic Oral Spray Due to CGMP Deviations

    Sprayology is recalling 1,465 bottles of DigestivEase Homeopathic Oral Spray due to manufacturing conditions that could result in microbial contamination.

    Product
    DigestivEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879.NDC 61096-0005-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0112-2019·2018-11-07

    Sprayology Recalls Cold + Flu Relief Homeopathic Oral Spray

    Sprayology is recalling Cold + Flu Relief Homeopathic Oral Spray due to CGMP deviations that could result in microbial contamination.

    Product
    Cold + Flu Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0002-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0356-2019·2018-11-07

    Caito Foods Recalls Southwest Sweet Potato Rice Due to Contamination Risk

    Caito Foods LLC is recalling 920 units of Southwest Sweet Potato Rice due to potential contamination with Listeria monocytogenes or Salmonella.

    Product
    SOUTHWEST SWEET POTATO RICE; 12oz. Plastic Clamshell; Keep Refrigerated; UPC 0826766185610
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0292-2019·2018-11-07

    CMP Industries Recalls Dental Resin Liquid Due to Foreign Material

    CMP Industries is recalling specific lots of Impak Elastic Acrylic Resin Liquid because foreign material was found in the product.

    Product
    IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml) REF:3306. Product Usage - Impak Elastic Acrylic Resin Liquid, Used for Dental Splints and Dental Nightguards
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0359-2019·2018-11-07

    Caito Foods Recalls Street Corn for Listeria and Salmonella Contamination

    Caito Foods LLC is recalling 115 units of Street Corn due to potential contamination with Listeria monocytogenes or Salmonella. The product was distributed in seven states.

    Product
    STREET CORN; 6oz. Plastic Clamshell; Keep Refrigerated; UPC 0884853641067
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0334-2019·2018-11-07

    Buddy's Kitchen Recalls Beef Barbacoa on Telera Due to Contamination Risk

    Buddy's Kitchen is recalling Beef Barbacoa on Telera due to potential Listeria or Salmonella contamination linked to a McCain Foods recall.

    Product
    Beef Barbacoa on Telera, Item 70663. Net Weight 13.92 lbs. 33 - 6.75 oz. portions. Keep Frozen. For institutional use only. Buddy's Kitchen, Inc., Burnsville, MN 55337
    Category
    Food
    Distribution
    8 states