The Recall Desk

Hazard

Mis Labeling recalls

9,607 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
9,607
Critical
160
Severe
588
Most recent
2026-09-10

Of the 9,607 mis labeling recalls we have scored against our rubric, 160 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 588 (6%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all mis labeling recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

3026–3050 of 9607

  • ModerateFDA (Devices)·Z-0708-2019·2019-01-16

    Biomet DVR Crosslock Screws Recalled for Incorrect Length Labeling

    Zimmer Biomet is recalling two lots of Biomet DVR Crosslock Screws because the physical screw lengths do not match the labels.

    Product
    Biomet DVR Crosslock Screws- 2.7mm x 20mm, Sterile ITEM 131827120 Product Usage: The system is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions (osteotomies) of small bones of the hand
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0689-2019·2019-01-09

    Ortho-Clinical Diagnostics Recalls VITROS NT-proBNP Reagent for Biased Results

    Ortho-Clinical Diagnostics is extending a 2018 recall of VITROS NT-proBNP Reagent because it may produce biased results at low biotin concentrations.

    Product
    VITROS NT-proBNP Reagent, Cat No. 6802156 Product Usage: For in vitro diagnostic use only. For the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0691-2019·2019-01-09

    R&D Systems Recalls Human sTfR ELISA Kits Due to Incorrect Control Card

    R&D Systems is recalling 198 Human sTfR ELISA kits because they were packed with the wrong control data card number.

    Product
    Quantikine¿ IVD¿ ELISA, Human sTfR Immunoassay kit. Product Usage: The QuantikineTM IVDTM sTFR Enzyme linked immunosorbent assay is intended for the measurement of sTfR concentration in human serum or plasma as an aid in the diagnosis of iron deficiency anemia, especially the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0347-2019·2019-01-02

    Phenylephrine HCl Injectable Solution Recalled for Incorrect Concentration Labeling

    Advanced Pharma Inc. is recalling 225 syringes of Phenylephrine HCl injectable solution because the label incorrectly states the concentration as 10 mcg per mL instead of 100 mcg per mL.

    Product
    Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL incorrectly labeled as (10 mcg per mL), 10 mL syringe, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, (877) 794-0404; NDC: 42852-802-61.
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Devices)·Z-0674-2019·2019-01-02

    Tosoh Bioscience Recalls ST AIA-PACK Testosterone Diagnostic Test Kits

    Tosoh Bioscience is voluntarily recalling ST AIA-PACK Testosterone kits due to a Class II defect. The recall covers 26,745 units distributed nationwide.

    Product
    ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers. Measurement of testosterone is used to aid in the diagnosis and management of conditions involving e
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0673-2019·2019-01-02

    Tosoh Bioscience Recalls ST AIA-PACK FT3 In Vitro Diagnostic Reagents

    Tosoh Bioscience Inc is voluntarily recalling ST AIA-PACK FT3 reagents used for in vitro diagnostic testing of Free Triiodothyronine. The recall covers 24,083 units distributed nationwide.

    Product
    ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Free Triiodothyronine (FT3) in human serum or heparinized plasma on specific Tosoh AIA System analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0672-2019·2019-01-02

    Tosoh Bioscience Recalls AIA-PACK Folate In Vitro Diagnostic Reagents

    Tosoh Bioscience Inc is voluntarily recalling AIA-PACK Folate reagents used for in vitro diagnostic testing due to a Class II safety concern.

    Product
    AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on Tosoh AIA System analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0675-2019·2019-01-02

    Tosoh Bioscience Recalls ST AIA-PACK Homocysteine Diagnostic Reagents

    Tosoh Bioscience is recalling 992 units of ST AIA-PACK Homocysteine reagents used for in vitro diagnostic testing. The voluntary recall covers all lots distributed nationwide.

    Product
    ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human serum, heparinized plasma or EDT A plasma on TOSOH AIA System Analyzers. Homocysteine measurements are used in the diagnosis and treatment of hype
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0660-2019·2019-01-02

    Randox SP CAL (LIQ) Calibrator Recall for Value Sheet Corrections

    Randox Laboratories is recalling SP CAL (LIQ) calibrators because value sheets were modified to improve alignment for specific assays.

    Product
    SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.
    Category
    Medical Device
    Distribution
    5 states
  • CriticalFDA (Food)·F-0748-2019·2018-12-26

    Bakkavor Baked Macaroni and Cheese Recalled for Undeclared Allergens

    Bakkavor Foods USA Inc. is recalling Baked Macaroni and Cheese because it contains lobster, shrimp, and soy that are not listed on the label.

    Product
    Baked Macaroni and Cheese, NET WT 12 OZ (340g), CONTAINS: WHEAT, MILK, EGG, Produced By BAKKAVOR USA, 2700 Westinghouse Blvd. Charlotte, NC 28273, Phone: 704-522-1977, UPC 7 61088 80502 3
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0353-2019·2018-12-26

    Dyural-40 Injection Kit Recalled for Incorrect Latex Labeling

    Asclemed USA Inc. is recalling Dyural-40 Injection Kits because the product insert incorrectly states that the stoppers do not contain latex, when they actually do.

    Product
    Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0750-01
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0354-2019·2018-12-26

    Enovachem Recalls Dyural-80 Injection Kits Due to Incorrect Latex Labeling

    Enovachem is recalling Dyural-80 Injection Kits because the product insert incorrectly stated that the stoppers do not contain latex, when they actually contain natural rubber latex.

    Product
    Dyural-80 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0755-01
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0338-2019·2018-12-26

    Gordon Laboratories Recalls Monsel's Solution Due to High Iron Levels

    Gordon Laboratories is recalling specific batches of Monsel's (Ferric Subsulfate) Solution because they contain higher levels of iron than labeled.

    Product
    Monsel's (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories, Upper Darby, PA 19082, NDC 10481-0112-8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0740-2019·2018-12-26

    Danone Recalls Light & Fit Greek Crunch Yogurt for Peanut Mislabeling

    Danone is recalling Light & Fit Greek Crunch Nonfat Yogurt & Toppings S Mores Flavor because some toppers contain peanuts but are not labeled as such.

    Product
    LIGHT & FIT¿ GREEK CRUNCH NONFAT YOGURT & TOPPINGS S MORES FLAVOR, 5 oz Preformed cups with a topper, Refrigeration required between 36F and 45F, UPC 36632 03825
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-0750-2019·2018-12-26

    Moonstruck Chocolate Recalls Salty Nutty Toffee Bar for Undeclared Soy

    Moonstruck Chocolate Company is recalling 323 bars of ALMA Salty Nutty Toffee Bar because the product contains undeclared soy lecithin.

    Product
    The Salty Nutty Toffee Bar, brand ALMA, net weight 1.85 oz. UPC on individual bar: 8 58533 00602 8 UPC on master case 0 108585 330060 2 The label is read in parts: "***INGREDIENTS: Salty Nutty Toffee Bar *** Dark Chocolate (cocoa solids, cocoa butter, sugar, sunflower lec
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0649-2019·2018-12-26

    Foundation Medicine Recalls 800 FoundationOne CDx Test Reports

    Foundation Medicine is recalling 800 FoundationOne CDx test reports because an incorrect result for a single analyte may have been reported.

    Product
    FoundationOne CDx Test Results
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0731-2019·2018-12-26

    Turkey Hill Vanilla Bean Ice Cream Recalled for Unlabeled Soy

    Harris Teeter is recalling Turkey Hill Vanilla Bean Ice Cream because some containers contained Cotton Candy Ice Cream with unlabeled soy lecithin.

    Product
    TURKEY HILL Vanilla Bean Premium Ice Cream #501 3 GAL (11.36L) paper carton CONTAINS: MILK Distributed By: Turkey Hill Dairy 2601 River Rd. Conestoga, PA 17618, call 1-800-MY DAIRY or www.turkeyhill.com, Mfd. at plant #37-087, UPC 0 20735 13520 4
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0340-2019·2018-12-26

    KVK-Tech Recalls Oxybutynin Chloride Tablets Due to Wrong Bar Code

    KVK-Tech, Inc. is recalling 156 bottles of Oxybutynin Chloride Tablets, 5 mg, because they bear the wrong bar code.

    Product
    OXYBUTYNIN CHLORIDE — OXYBUTYNIN CHLORIDE (OXYBUTYNIN CHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0633-2019·2018-12-26

    Cardinal Health Recalls Protexis Neoprene Surgical Gloves Due to Labeling Errors

    Cardinal Health is recalling Protexis Neoprene Surgical Gloves because the packaging lists incorrect breakthrough times for specific chemotherapy drugs.

    Product
    Protexis Neoprene Surgical Glove, Size 6.5 This powder-free Surgeon s glovessterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0636-2019·2018-12-26

    Cardinal Health Recalls Protexis Neoprene Surgical Gloves Due to Labeling Errors

    Cardinal Health is recalling Protexis Neoprene Surgical Gloves because the packaging contains incorrect breakthrough times for specific chemotherapy drugs.

    Product
    Protexis Neoprene Surgical Glove, Size 8.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0637-2019·2018-12-26

    Cardinal Health Recalls Protexis Neoprene Surgical Gloves Due to Labeling Error

    Cardinal Health is recalling Protexis Neoprene Surgical Gloves because the packaging contains incorrect breakthrough times for specific chemotherapy drugs.

    Product
    Protexis Neoprene Surgical Glove, Size 8.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0644-2019·2018-12-26

    Zimmer GmbH Recalls Mislabeled Avenir Muller Stem Hip Implants

    Zimmer GmbH is recalling 13 units of Avenir Muller Stem hip implants because size 1 stems were packaged as size 2. The recall covers distribution in Germany and Switzerland.

    Product
    Avenir¿ Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.06010.001 - Product Usage: Avenir@ Muller Stems are intended to reduce pain and increase hip mobility through long term cementless fixation of total or hemi hip arthroplasty in the femur of patients with
    Category
    Medical Device
    Distribution
    0 states