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.

4526–4550 of 9607

  • ModerateFDA (Devices)·Z-2173-2017·2017-06-07

    Roche Recalls PreciControl Varia 3 Due to Typographical Error

    Roche Diagnostics is recalling 1,603 units of Elecsys PreciControl Varia 3 because the e-barcode and value sheet contain a typographical error for PTH target values.

    Product
    Elecsys PreciControl Varia 3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0880-2017·2017-06-07

    Saphris Asenapine Tablets Recalled for Labeling Mixup

    Forest Laboratories is recalling Saphris (asenapine) sublingual tablets because blister packs labeled as 10 mg actually contain 5 mg tablets.

    Product
    SAPHRIS — SAPHRIS (ASENAPINE MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2218-2017·2017-06-07

    Invacare Assist Bed Rail 6632 Recalled for Manual Typo

    Invacare is recalling 5,020 Assist Bed Rail 6632 units because a typo in the user manual could lead to incorrect installation.

    Product
    Assist Bed Rail - 6632
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2209-2017·2017-06-07

    Cell Marque Recalls CD117 Reagents Due to Missing Export Labeling

    Cell Marque is recalling CD117, c-kit reagents because they were not labeled 'For Export Only' as required by the FD&C Act.

    Product
    CD117, c-kit (YR145) 1.0 ml catalog number 117R-16 7.0 ml catalog number-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2205-2017·2017-06-07

    Cell Marque Recalls Herpes Simplex Virus I Reagents Due to Labeling Error

    Cell Marque is recalling Herpes Simplex Virus I reagents because they were not properly labeled as 'For Export Only' as required by the FD&C Act.

    Product
    Herpes Simplex Virus I; 7.0 mL Catalog number 361A-18. Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2167-2017·2017-06-07

    Randox Liquid Urine Control Level 3 Recalled for Labeling Error

    Randox Laboratories is recalling 198 kits of Liquid Urine Control Level 3 due to a labeling error affecting Total Protein values.

    Product
    Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a range of clinical chemistry systems.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-2208-2017·2017-06-07

    Cell Marque Recalls Varicella Zoster Virus Reagent Due to Labeling Error

    Cell Marque is recalling Varicella Zoster Virus reagents because they were not properly labeled as 'For Export Only' as required by the FD&C Act.

    Product
    Varicella Zoster Virus 7.0 ml catalog number 364M-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2204-2017·2017-06-07

    Cell Marque Recalls Her2/Neu Reagents for Missing Export Labeling

    Cell Marque is recalling Her2/Neu (EP3) reagents because they were not properly labeled as 'For Export Only' as required by the FD&C Act.

    Product
    Her2/Neu (EP3); 0.5 mL Catalog number 237R-25; 1.0 mL Catalog number 237R-26; 7.0 mL Catalog number 237R-28. Immunology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2201-2017·2017-06-07

    Cell Marque Recalls Estrogen Reagent Due to Missing Export Labeling

    Cell Marque is recalling 8 units of Estrogen Receptor reagent because they were not properly labeled as 'For Export Only' as required by the FD&C Act.

    Product
    Estrogen Receptor (SP1) 7.0 mL Catalog number 249R-18; Hematology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2207-2017·2017-06-07

    Cell Marque Recalls SV40 Reagent Due to Missing Export Labeling

    Cell Marque is recalling three units of SV40 (MRQ-4) reagent because they were not labeled 'For Export Only' as required by law.

    Product
    SV40 (MRQ-4) 0.5 ml catalog number 351 M-15. Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2210-2017·2017-06-07

    Cell Marque Recalls HHV-8 Reagent Due to Export Labeling Error

    Cell Marque is recalling HHV-8 in vitro diagnostic reagents because they were not properly labeled as 'For Export Only' as required by the FD&C Act.

    Product
    HHV-8 (13810); 1.0 ml catalog number 265M-16; 7.0 ml catalog number-265M-18; Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2168-2017·2017-06-07

    Tosoh AIA-PACK TPOAb Control Set Recalled for Labeling Errors

    Tosoh Bioscience is recalling 15 boxes of AIA-PACK TPOAb Control Sets because the labels included instructions for a non-FDA approved methodology.

    Product
    AIA-PACK TPOAb CONTROL SET
    Category
    Medical Device
    Distribution
    8 states
  • LowFDA (Devices)·Z-2199-2017·2017-06-07

    Cell Marque Recalls Adenovirus Reagents Due to Export Labeling Error

    Cell Marque is recalling Adenovirus reagents because they were not properly labeled as 'For Export Only' as required by the FD&C Act.

    Product
    Adenovirus (20/11 & 2/6); 0.5 mL Catalog # 212M-15; and 7.0 mL Catalog number 212M-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2213-2017·2017-06-07

    Acumedia Nutrient Gelatin Recalled for Incorrect Expiration Date Labeling

    Acumedia Manufacturers recalled 5 units of Nutrient Gelatin because the label displayed an incorrect expiration date.

    Product
    Nutrient Gelatin, Acumedia Part Number 7471 A Product Usage: Nutrient Gelatin is used for the differentiation of microorganisms on the basis of gelatinase production. Identifying fermentative and non-fermentative Gram-negative bacilli include testing for gelatin liquefaction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2200-2017·2017-06-07

    Cell Marque Recalls Estrogen Reagent Due to Missing Export Labeling

    Cell Marque is recalling specific lots of Estrogen Receptor reagents because they were not labeled 'For Export Only' as required by law.

    Product
    Estrogen Receptor (EP1) 7.0 mL Catalog number 249R-28; 1.0 mL Catalog number 249R-16 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2214-2017·2017-06-07

    Acumedia Recalls Beef Extract Powder Due to Incorrect Expiration Date

    Acumedia Manufacturers, Inc. is recalling 16 units of Beef Extract Powder (PN 7228) because the label displays an incorrect expiration date.

    Product
    Beef Extract Powder, Acumedia PN 7228 Product Usage: Beef Extract Powder is prepared and standardized for use in microbiological culture media, where it is generally used to replace infusion of meat. Culture media containing Beef Extract Powder are recommended for use in bact
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2212-2017·2017-06-07

    Acumedia Sabouraud Dextrose Agar Recalled for Incorrect Storage Labeling

    Acumedia is recalling 10 units of Sabouraud Dextrose Agar in Illinois due to incorrect storage temperature information on the label.

    Product
    Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Product Usage: Used for the isolation of fungi from surfaces sanitized with quaternary ammonium compounds
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-2206-2017·2017-06-07

    Cell Marque Recalls Herpes Simplex Virus II Reagents for Labeling Errors

    Cell Marque is recalling specific lots of Herpes Simplex Virus II reagents because they were not properly labeled as 'For Export Only' as required by federal law.

    Product
    Herpes Simplex Virus II 0.5 ml catalog number 362A-15 7.0 mL Catalog number362A-18 . Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2203-2017·2017-06-07

    Cell Marque Recalls Her2/Neu Reagent Due to Missing Export Labeling

    Cell Marque is recalling Her2/Neu (c-erbB-2) reagents because they were not labeled as 'For Export Only' as required by law.

    Product
    Her2/Neu (c-erbB-2) (CB-1 1); 7.0 mL Catalog number 237M-18. In vitro diagnostic use - Analyte Specific Reagent Immunology - Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2202-2017·2017-06-07

    Cell Marque Recalls H. pylori Reagent Due to Missing Export Labeling

    Cell Marque is recalling five units of H. pylori reagent because they were not properly labeled as 'For Export Only' as required by the FD&C Act.

    Product
    H. pylori (polyclonal} 1.0 mL Catalog number 215A-76; Hematology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0806-2017·2017-05-31

    Advanced Pharma Recalls Early Baby TPN Due to Latex Labeling

    Advanced Pharma Inc. is recalling Early Baby TPN (Neonatal) because the product may contain synthetic or natural latex, which is not currently labeled.

    Product
    Early Baby TPN (Neonatal) all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0809-2017·2017-05-31

    Advanced Pharma Recalls Fentanyl Citrate Due to Latex Labeling Deficiency

    Advanced Pharma Inc. is recalling all lots of Fentanyl Citrate because the product labeling does not indicate that it may contain synthetic or natural latex.

    Product
    Fentanyl Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0805-2017·2017-05-31

    Advanced Pharma Recalls Early TPN Neonatal Products for Latex Labeling

    Advanced Pharma Inc. is recalling Early TPN (Neonatal) products nationwide due to a labeling error regarding potential latex content.

    Product
    Early TPN (Neonatal) all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide