The Recall Desk

Hazard

Mis Labeling recalls

9,622 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
9,622
Critical
163
Severe
590
Most recent
2026-09-24

Of the 9,622 mis labeling recalls we have scored against our rubric, 163 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 590 (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.

9126–9150 of 9622

  • ModerateFDA (Food)·F-0711-2013·2012-11-28

    Schoep's Recalls Toasted Butter Pecan Ice Cream Due to Packaging Error

    Schoep's Ice Cream Co. is recalling Toasted Butter Pecan ice cream packaged in Vanilla Bean containers due to a labeling error.

    Product
    Tub labeled as Kay's Classic Vanilla Bean ice Cream. UPC 87848-13021, 1.5 Quarts (1.42L). Lid labeled as Kay's Classic Toasted Butter Pecan ice cream
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0323-2013·2012-11-28

    BioMerieux B.40 Dualt-ML Software Update Recalled for Mislabeling Risk

    BioMerieux is recalling B.40 Dualt-ML software updates because a software miscommunication may cause patient information to be mislabeled on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, B.40 Dualt-ML, Industry instrument software update, English, Spanish, Italian, German, French, Japanese, Brazilian, Portuguese, catalog number 412950 Software update for an instrument which is most commonly used to isolate and recover speci
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0300-2013·2012-11-28

    BioMerieux BacT/ALERT Combo Modules Recalled for Software Mislabeling

    BioMerieux is recalling 375 BacT/ALERT Combo Modules due to a software error that may mislabel patient information on culture specimen bottles.

    Product
    bioMerieux BacT/ALERT Combo Module, catalog number, 200290, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, w
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0322-2013·2012-11-28

    BioMérieux 3D IND Software Update Recalled for Patient Mislabeling

    BioMérieux is recalling 20 kits of the 3D IND USB-ML 02 software update because a software miscommunication may cause patient information to be mislabeled on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, 3D IND USB-ML 02, Industry instrument software update, English, Spanish, Italian, catalog number 412006 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric pati
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0308-2013·2012-11-28

    BioMerieux 3D B.40 Software Update Recalled for Patient Mislabeling

    BioMerieux is recalling 671 units of the 3D B.40 software update because a software miscommunication may cause patient information to be mislabeled on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML06, Clinical instrument software, Japanese, Korean, Norwegian, Brazilian, Portuguese, Turkish, catalog number 412626 Software update for the clinical instrument which is most commonly used to isolate and recover specimens dra
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0315-2013·2012-11-28

    BioMerieux 3D B.40 Software Update Recalled for Mislabeling Risk

    BioMerieux is recalling 28 software updates for the 3D B.40 instrument due to a defect that may mislabel patient information on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML04, Clinical instrument software, Czech, Estonian, Hungarian, Romanian, catalog number 412620 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0321-2013·2012-11-28

    BioMerieux 3D IND ZIP-ML Software Update Recalled for Mislabeling

    BioMerieux is recalling 288 units of the 3D IND ZIP-ML software update because a defect may cause patient information to be mislabeled on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, 3D IND ZIP-ML 01, Industry instrument software update, English, Spanish, Italian, catalog number 412005 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric pati
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0304-2013·2012-11-28

    BioMérieux 3D B.40 Software Update Recalled for Patient Mislabeling

    BioMérieux is recalling 30 units of the 3D B.40 software update because a software miscommunication may cause patient information to be mislabeled on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, 3D B.40 BTA3D-ZH01, Clinical instrument software, Chinese, catalog number 411816 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that ar
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0328-2013·2012-11-28

    Biomerieux B.40 Software Update Recalled for Patient Information Mislabeling

    Biomerieux Inc is recalling 33 B.40 software updates because a software miscommunication may cause patient information to be mislabeled on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 413483 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric p
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0310-2013·2012-11-28

    BioMerieux 3D B.40 Software Update Recalled for Mislabeling Patient Information

    BioMerieux is recalling 556 units of 3D B.40 software updates because a software miscommunication may cause patient information to be mislabeled on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML02, Clinical instrument software, German, French, Swedish, catalog number 411925 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric pa
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0306-2013·2012-11-28

    BioMerieux 3D B.40 Software Update Recalled for Patient Mislabeling

    BioMerieux is recalling a software update for the 3D B.40 clinical instrument because it may mislabel patient information on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML04, Clinical instrument software, Czech, Estonian, Hungarian, Romanian, catalog number 412624 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0307-2013·2012-11-28

    BioMérieux 3D B.40 Software Update Recalled for Patient Mislabeling

    BioMérieux is recalling 163 units of the 3D B.40 software update because a defect may cause patient information to be mislabeled on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML05, Clinical instrument software, Lithuanian, Latvian, Russian, Slovak, catalog number 412625 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0314-2013·2012-11-28

    BioMérieux 3D B.40 Software Update Recalled for Patient Mislabeling

    BioMérieux is recalling 29 units of the 3D B.40 USB-ML03 software update due to a defect that may mislabel patient information on culture specimen bottles.

    Product
    bioMerieux Kit, USB Instrument & Update, 3D B.40 USB-ML03, Clinical instrument software, Danish, Greek, Polish, Portuguese, catalog number 412559 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older
    Category
    Medical Device
    Distribution
    19 states
  • LowFDA (Food)·F-0710-2013·2012-11-28

    Postres de Aqui Oatmeal Recalled for Missing Phenylketonuria Warning

    Postres de Aqui, Inc. is recalling 8-ounce boxes of Avena de Aqui Si Azucar Añadida because the packaging lacks a required warning for individuals with phenylketonuria.

    Product
    "***Avena de Aqu¿ Si Azucar A¿adida****8oz****Fabricado por Postres de Aqui, Inc. Calle B Parrio Plamas Cata¿o PR 00962***"
    Category
    Food
    Distribution
    1 state
  • LowFDA (Devices)·Z-0429-2013·2012-11-28

    Horiba Medical Recalls Minotrol 16 Hematology Control Material

    Horiba Medical is recalling Minotrol 16 lot MX090 (Level High) due to reports of high hemoglobin recovery values.

    Product
    Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels: Low, Normal, and High). Minotrol 16 is a tri-level control intended for in vitro diagnostic use in monitoring the accuracy and precision on HORIBA Medical hematology blood cell counters using HORI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0386-2013·2012-11-28

    Zimmer Recalls Trilogy Longevity Constrained Liners Due to Packaging Error

    Zimmer, Inc. is recalling Trilogy Longevity Constrained Liners because they were packaged in incorrect cartons, although the product labels are correct.

    Product
    Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the articular surface for a femoral head in total hip arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0681-2013·2012-11-21

    Zatarain's Beef Flavor Rice Mix Recalled for Undeclared Wheat

    McCormick & Company is recalling Zatarain's New Orleans Style Beef Flavor Rice Mix because the product contains wheat but the label does not declare it.

    Product
    Zatarain's New Orleans Style Beef Flavor Rice Mix, packaged in 6.8 oz boxes, 12 boxes per carton, Box UPC: 7142901001
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0682-2013·2012-11-21

    Zatarain's Chicken Flavor Rice Mix Recalled for Undeclared Wheat

    McCormick & Company is recalling Zatarain's New Orleans Style Chicken Flavor Rice Mix because the product contains wheat but the label does not declare it.

    Product
    Zatarain's New Orleans Style Chicken Flavor Rice Mix, Item No. Z09705, packaged in 6.3 oz boxes, 12 boxes per carton, Box UPC: 7142901001
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0698-2013·2012-11-21

    Zatarain's Chicken and Cheddar Broccoli Mix Recalled for Undeclared Wheat

    McCormick & Company is recalling Zatarain's Chicken/Cheddar Broccoli Mix because the product contains wheat but the label does not declare it.

    Product
    Zatarain's Chicken/Cheddar Brocolli Mix, Item Number: 900108337, a combination pack containing, 6.3 oz boxes of New Orleans Style Chicken Flavor Rice Mix and Cheddar Broccolli Mix.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0277-2013·2012-11-21

    Synthes External Fixation Clamp Recalled for Incorrect MR Safety Labeling

    Synthes USA HQ, Inc. is recalling 8 units of External Fixation System Tube to Tube Clamps because the provided insert incorrectly states the product is MR safe, while the device is actually MR Conditional.

    Product
    Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007. Intended for use to provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for: Stabilization of soft tissues and fractures; Polytra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-051-2013·2012-11-21

    Stat Rx USA Recalls Venlafaxine ER Due to Labeling Error

    Stat Rx USA is recalling 5 bottles of Venlafaxine ER 150mg because the label incorrectly identifies the dosage form as 'Tabs' instead of 'Capsules.'

    Product
    Venlafaxine ER 150mg, 30 Tabs bottle, Generic for: Effexor, Packaged and Distributed by: Stat Rx USA, LLC, Gainesville, GA 30501 NDC 42549-684-30
    Category
    Drug
    Distribution
    2 states
  • LowFDA (Drugs)·D-050-2013·2012-11-21

    Stat Rx USA Recalls Tobramycin Ophthalmic Ointment Due to Labeling Error

    Stat Rx USA is recalling 22 units of Tobramycin Ophthalmic Ointment because the labels incorrectly identify the product as an ointment instead of a solution.

    Product
    Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only, Sterile, Mfg By Akorn, Inc., Lake Forest, IL 60045, NDC 16590-224-05,
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0231-2013·2012-11-14

    Zimmer Recalls Shoulder Humeral Inserts Due to Label Discrepancies

    Zimmer Inc. is correcting patient labels for 74 anatomical shoulder humeral inserts manufactured before March 2010 due to reported discrepancies in reference and lot numbers.

    Product
    Anatomical Shoulder" Inverse/Reverse Humeral PE-Insert Sterile, Rx
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-045-2013·2012-11-14

    Valeant Recalls Subpotent AcneFree Benzoyl Peroxide Tubes Nationwide

    Valeant Pharmaceuticals is recalling 619,029 tubes of AcneFree Original Strength Terminator because the product is subpotent and mislabeled.

    Product
    AcneFree Original Strength Terminator (benzoyl peroxide 5% w/v), 1 oz. (28 g) tube, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, AFCS-0402, UPC 7 88521 12030 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-043-2013·2012-11-14

    Valeant Recalls Subpotent AcneFree 24 Hour Severe Acne Clearing System

    Valeant Pharmaceuticals is recalling AcneFree 24 Hour Severe Acne Clearing System cartons because the benzoyl peroxide ingredient is subpotent and the product is mislabeled.

    Product
    AcneFree 24 Hour Severe Acne Clearing System containing 1-count 4 fl oz (118 mL) bottle Antibacterial Cleansing Wash (benzoyl peroxide 2.5% w/v) AFSV-0101-00, 1-count 4 fl oz (118 mL) bottle Corrective Toner AFSV-0201-01, 1-count 2 fl oz (59 mL) bottle Maximum Strength Repair Lot
    Category
    Drug
    Distribution
    Distributed nationwide