The Recall Desk

Hazard

Mis Labeling recalls

9,611 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
9,611
Critical
161
Severe
589
Most recent
2026-09-24

Of the 9,611 mis labeling recalls we have scored against our rubric, 161 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 589 (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.

8526–8550 of 9611

  • LowFDA (Drugs)·D-909-2013·2013-08-28

    Novartis Recalls Maalox Nighttime Antacid Due to Illegible Packaging Labels

    Novartis Consumer Health is recalling Maalox Nighttime Antacid chewable tablets because the lot number or expiration date may be illegible on the outer plastic bottle packaging.

    Product
    Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and alginic acid) chewable tablets, 500 mg/200 mg, Mint flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 80
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-906-2013·2013-08-28

    Novartis Recalls Maalox Extra Strength Antacid Tablets Due to Illegible Labeling

    Novartis is recalling Maalox Extra Strength Antacid chewable tablets because the lot number or expiration date may be illegible on the outer plastic bottle packaging.

    Product
    Maalox Extra Strength Antacid (calcium carbonate) chewable tablets,1000 mg, Wild Berry flavor, packaged in a) 35-count (UPC 0 58478 44829 9) and b) 65-count (UPC 0 58478 44842 8) tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling c
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1800-2013·2013-08-21

    Tortillas Lupita White Corn Tortillas Recalled for Undeclared Wheat

    Tortillas Lupita is recalling White Corn Tortillas because flour tortillas were mislabeled as corn, containing undeclared wheat.

    Product
    Tortillas Lupita White Corn Tortillas, Manufactured by Tortilleria Lupita, 235 SW 25th St, Oklahoma City, OK 73109
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1796-2013·2013-08-21

    Red Mill Farms Recalls Chocolate Macaroons Due to Undeclared Sugar

    Red Mill Farms is recalling Jennies' Dutch Chocolate Macaroons because the packaging fails to list sugar as an ingredient.

    Product
    individual 2 oz chocolate macaroons packaged in plastic wrapper labeled as " Jennies DUTCH CHOCOLATE MACAROON, 2 oz. Red Mill Farms, Inc., Brooklyn, NY".
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1961-2013·2013-08-21

    Biomet 3i Dental Implant Recall for Potential Outer Box Mislabeling

    Biomet 3i is recalling 33 dental implants because outer boxes may be mislabeled. The inner trays are correctly labeled, but the error could prevent proper implant placement.

    Product
    Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (L)
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1969-2013·2013-08-21

    Terumo Advanced Perfusion System 1 Recall for Incomplete Operator Manual

    Terumo is recalling 1,657 Advanced Perfusion System 1 units because the operator manual does not fully describe pump reactions during specific alarm conditions.

    Product
    Terumo¿ Advanced Perfusion System 1: 220/240V AC, Advanced Perfusion System 1 The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1968-2013·2013-08-21

    Terumo Advanced Perfusion System 1 Recalled for Incomplete Operator Manual Instructions

    Terumo is recalling 1,657 Advanced Perfusion System 1 units because the operator manual does not fully describe pump behavior during specific alarm conditions.

    Product
    Terumo¿ Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1 The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1802-2013·2013-08-21

    Ancient Formulas Recalls Keytabs W.O. Glandulars Due to Niacin Levels

    Ancient Formulas Inc is recalling 51,000 bulk tablets of Keytabs W.O. Glandulars because the product contains higher levels of niacin than claimed on the label.

    Product
    Bulk tablet label: Keytabs W.O. Glandulars (pink)
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1804-2013·2013-08-21

    Walong Marketing Recalls Asian Taste Sunflower Seeds for Undeclared Sulfites

    Walong Marketing is recalling Asian Taste Sunflower Seeds because they may contain undeclared sulfites. The recall affects 1,090 cartons distributed in California.

    Product
    Asian Taste Sun Flower Seeds, 40pk/carton, Net Wt: 8-oz. (227g), Item #1641819, UPC 6 919037 022708.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1941-2013·2013-08-21

    OrthoPediatrics Recalls 2.5mm Drill Bits Due to Packaging Labeling Error

    OrthoPediatrics is voluntarily recalling 68 packaged 2.5mm drill bits because the packaging incorrectly lists the size as 3.2mm.

    Product
    3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in bone prior to placement of a bone screw.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1965-2013·2013-08-21

    Arrow International Recalls Two-Lumen CVC Kits Due to Labeling Error

    Arrow International is recalling 156 Two-Lumen CVC Kits because a portion of the packaging incorrectly identifies the catheter as 3-Lumen.

    Product
    Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1975-2013·2013-08-21

    Siemens syngo.plaza Mammography Software Recall for Image Alignment Issues

    Siemens is recalling syngo.plaza software due to potential issues with mammography image laterality and alignment.

    Product
    Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1934-2013·2013-08-21

    Medtronic Xomed Recalls ENT Surgical Instrument Trays for Labeling Defects

    Medtronic Xomed is recalling 3,562 ENT surgical instrument trays to replace them with units featuring improved 'PREVACUUM ONLY' labeling.

    Product
    Tray Surgical, ENT (various instrument trays) Used for stot age and transportation of reusable surgical instruments utilized in various ear, nose and throat (ENT) and head and neck surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1803-2013·2013-08-21

    Ancient Formulas Recalls KEYTABS Tablets Due to Higher Niacin Levels

    Ancient Formulas Inc is recalling KEYTABS tablets because they contain higher levels of niacin than stated on the label.

    Product
    KEYTABS (Without Iron, Copper or Glandulars), packaged in 180-tablet bottles, a product of The Key Company, St. Louis, MO.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1960-2013·2013-08-21

    Biomet 3i Dental Implant Recall Due to Outer Box Mislabeling

    Biomet 3i is recalling 51 dental implants because outer boxes may be mislabeled. The implants themselves are correctly labeled, but the error could prevent proper placement.

    Product
    Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L)
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1973-2013·2013-08-21

    Terumo Advanced Perfusion System 1 Recalled for False Pump Service Error

    Terumo is recalling Advanced Perfusion System 1 units because user-induced movement may trigger a false 'Service Pump' error message, potentially causing unnecessary service delays.

    Product
    Terumo¿ Advanced Perfusion System 1 (APS1, System 1) 100/120V AC Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1962-2013·2013-08-21

    Remel Flu A&B Control Swabs Recalled for Incorrect Quality Control Results

    Remel Inc is recalling Flu A&B Control Swabs because they may provide incorrect negative results for Flu A, potentially compromising quality control testing.

    Product
    Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003, each package contains 20 Flu A Control Swabs and 20 Flu B Control Swabs, each swab is individually packaged in a foil pouch. The firm name on the label is Remel Europe, Ltd., Dartford, Kent, United Ki
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-888-2013·2013-08-21

    Hi-Tech Pharmacal Recalls Clobetasol Propionate Cream Due to Labeling Error

    Hi-Tech Pharmacal is recalling Clobetasol Propionate Cream because some cartons contain tubes with gel labels. The actual product inside is the correct cream.

    Product
    Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL label, Hi-Tech Pharmacal, Co., Inc., Amityville, NY 11701, NDC 50383-267-15 --- For dermatologic use only. Product is packaged into tubes and then placed into unit cartons.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1790-2013·2013-08-14

    Giant Eagle Chocolate Covered Peanuts Recalled for Undeclared Milk Allergen

    Giant Eagle is recalling Chocolate Covered Peanuts because the label fails to clearly state the presence of a milk allergen, listing only whey.

    Product
    Giant Eagle Candy Place Chocolate Covered Peanuts NET WT. 5 OZ, UPC code 3003404313 This product was packaged in a facility that also processes peanuts, nuts, milk products, soy, wheat, sesame seeds, whey and eggs. Distributed By: Giant Eagle, Inc. Pittsburgh, PA 15328-2809
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1928-2013·2013-08-14

    Smith & Nephew Recalls R3 XLPE Acetabular Liners Due to Packaging Error

    Smith & Nephew is recalling 53 units of R3 XLPE acetabular liners because some 60 mm and 62 mm liners may be laser etched and packaged with incorrect size labels.

    Product
    R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE H2O2, REF 71335762. Orthopaedic.
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1919-2013·2013-08-14

    BioMerieux Vitek 2 Software Recall for Antibiotic Code Errors

    BioMerieux is recalling Vitek 2 Systems Software version 6.01 because antibiotic codes for three specific drugs were not updated correctly during a software upgrade.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 EL, TR. Part number: 414568. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1913-2013·2013-08-14

    BioMérieux Vitek 2 Software Version 6.01 Recalled for Interface Error

    BioMérieux is recalling Vitek 2 software version 6.01 because antibiotic codes for three specific drugs are not updated correctly when interfaced with Laboratory Information Systems.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 FR. Part number: 414562. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the iden
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-842-2013·2013-08-14

    Teva Recalls Terazosin Hydrochloride Capsules Due to Labeling Error

    Teva Pharmaceuticals is recalling 6,267 bottles of Terazosin Hydrochloride capsules because the 10 mg label contained 5 mg capsules.

    Product
    Terazosin Hydrochloride Capsules,10 mg, 100-count bottle, Rx only, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-4339-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-854-2013·2013-08-14

    Sandoz Recalls Introvale Contraceptive Tablets Due to Sequence Error

    Sandoz is voluntarily recalling Introvale contraceptive tablets because inactive and active pills were placed in the wrong weeks on the blister card.

    Product
    Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, packaged in 91 day regimen per unit carton, 3 Unit Cartons x 91 tablets per box, Rx only, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5584-36
    Category
    Drug
    Distribution
    Distributed nationwide