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.

1376–1400 of 9607

  • HighFDA (Devices)·Z-2292-2021·2021-08-25

    Gore Propaten Vascular Graft Pediatric Shunt Dimension Labeling Error Recall

    W L Gore & Associates is recalling Gore Propaten Vascular Grafts for pediatric shunts due to incorrect diameter labeling: grafts with 6mm inner diameter are labeled 5mm, and those with 5mm diameter are labeled 6mm.

    Product
    Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT050010 UDI: (01)00733132606320 HPT050010A UDI: (01)00733132606337
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Food)·F-0919-2021·2021-08-25

    Holle Goat Stage 1 Organic Infant Milk Formula Recalled for Labeling Violations

    Able Groupe Inc is recalling Holle Goat Stage 1 Organic Infant Milk Formula because required FDA pre-market notifications were not submitted and products lack mandatory labeling statements in English.

    Product
    Holle Goat Stage 1 Organic Infant Milk Formula
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0912-2021·2021-08-25

    HiPP HA Infant Formula Recalled for Missing Pre-Market Notification

    Able Groupe Inc is recalling HiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk Formula because required pre-market notifications were not submitted to the FDA and products lack mandatory English labeling.

    Product
    HiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk Formula
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2239-2021·2021-08-18

    Cardiac Sheath Introducer Devices Recalled Due to Size Mislabeling

    Merit Medical Systems recalls 760 units of Prelude SNAP Splittable Sheath Introducer (7F) due to packaging errors where devices are labeled as 10F instead of the correct 7F size.

    Product
    Prelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, UDI:(01) 00884450467985. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-2254-2021·2021-08-18

    Simpleware ScanIP Medical Software Recall: Incorrect Anatomical Orientation Display

    Simpleware ScanIP medical software may display anatomical orientation tags incorrectly, potentially causing surgical planning errors. This FDA Class II recall affects versions from 2018–2021 distributed in the US and internationally.

    Product
    Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2246-2021·2021-08-18

    Mislabeled Cutting Electrode May Contain Wrong Electrode Type

    Richard Wolf's Cutting Electrode Bipo 24.5FR may be mislabeled and contain a BIVAP electrode instead. Affected lot 21002858 was distributed to healthcare facilities in five states.

    Product
    CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0858-2021·2021-08-18

    Molly and Me Pecans Recalled for Undeclared Soy

    Molly and Me Pecans praline pecans are being recalled because they contain undeclared soy, which poses a risk to consumers with soy allergies.

    Product
    MOLLY & ME PECANS all natural PRALINE PECANS, 4 oz., 7 oz., and 12 oz packages, INGREDIENTS: Pecans, Brown Sugar, Evaporated Milk, Margarine, Light Corn syrup, Artificial Vanilla Flavor. ALLERGEN INFORMATION CONTAINS MILK, PECANS & MAY CONTAIN OTHER TREE NUTS. PRODUCED & DISTRIBU
    Category
    Food
    Distribution
    28 states
  • HighFDA (Devices)·Z-2238-2021·2021-08-18

    Prelude SNAP cardiac introducer sheath potentially mislabeled with wrong size

    Merit Medical Systems is recalling Prelude SNAP Splittable Sheath Introducers (10F size) because 7F sheaths may have been packaged with 10F labels. This error affects 760 units in lot I2067768.

    Product
    Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 00884450489611. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
    Category
    Medical Device
    Distribution
    29 states
  • LowFDA (Food)·F-0859-2021·2021-08-18

    Wickles Relish 16oz Glass Jars Recalled for Wrong Label

    Magnolia Vegetable Processors is recalling Wickles Relish 16oz glass jars (Lot No. 2001210406) due to an incorrect label applied to the product. The affected cases were distributed to eight states.

    Product
    Wickles Relish 16oz glass jars - 6 jars per case
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-2169-2021·2021-08-11

    Regard Newborn Heel Warmer Kit Recalled for Inadequate Safety Instructions

    ROi CPS LLC is recalling the Regard NEWBORN KIT heel warmer (976 units in Missouri) due to incomplete safety instructions. Updated instructions now warn users to activate the device away from the infant's face and others.

    Product
    Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which includes an infant heel warmer.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0697-2021·2021-08-11

    Global Hand Sanitizer Recalled Due to Denaturant Deficiency

    Cascade Kelly Holdings LLC is recalling Global Hand Sanitizer with moisturizer because the product does not meet the required denaturant specifications for alcohol-based antiseptics.

    Product
    Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 4 fl. oz./119 mL, Alcohol 80% v/v, Manufactured by: Cascade Kelly Holdings LLC, NDC 80253-001-01
    Category
    Drug
    Distribution
    9 states
  • HighFDA (Food)·F-0807-2021·2021-08-04

    Choujuki White Bread recalled for undeclared milk allergen

    Choujuki White Bread (6 slices, 13.9 oz) is being recalled because labeling failed to declare milk as an allergen. The milk is a sub-ingredient of the margarine used in the product.

    Product
    Choujuki White Bread 6 slices: Net Wt. 13.9 oz. (374g) Ingredients: White Flour, Sugar, Margarine, Yeast Extract, Salt, Rice Flour, Vinegar. Contains Wheat. Keep Frozen at or below 18 degrees C Distributed by Hatsune JPN Inc., Torrance, CA Product of Japan/
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2159-2021·2021-08-04

    Medtronic Vectris SureScan MRI lead kits recalled for incorrect labeling

    Medtronic Neuromodulation is recalling 1131 units of Vectris SureScan MRI lead kits with incorrect electrode spacing information on packaging labels. This could affect proper device installation.

    Product
    Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0869-2021·2021-08-04

    Now Real Food Organic Steel Cut Oats Mislabeled with Wrong Product

    NOW Health Group Inc. is recalling a specific lot of Organic Steel Cut Oats that may contain Organic Beet Sugar instead of the labeled product. Affected consumers should not consume the product.

    Product
    Now Real Food Organic Steel Cut Oats, 2 lb bag, code 6295, UPC 733739062956, packed 8 bags per case; case packaging is for Now Real Food Organic Beet Sugar 3lbs bags
    Category
    Food
    Distribution
    45 states
  • HighFDA (Food)·F-0784-2021·2021-07-28

    Pow Pow Powders Vanilla Chai Powder Recalled for Undeclared Milk Allergen

    San Diego Coffee, Tea and Spice is recalling Pow Pow Powders Vanilla Chai because the product lacks ingredient and allergen labeling, leaving milk allergen undeclared. The recall affects smoothie mixes distributed in California.

    Product
    Pow Pow Powders: A standard of Quality Vanilla Chai; NET Wt. 3.50 lb. (1.59kg) Ingredients: Sugar, Non-Fat Dry Milk, Non-Dairy Creamer (coconut oil, Corn Syrup Solids, Sodium Caseinate (a milk derivative), Sodium Citrate, Mono and Diglycerides, Salt), Instant Black Tea, Honey,
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0788-2021·2021-07-28

    Heidi's Brownies Recalled for Undeclared Soy Allergen

    Heidi's Brownies are being recalled because soy lecithin is listed in the ingredients but soy is not mentioned in the allergen declaration on the label, posing a risk to people with soy allergies.

    Product
    Heidi's Brownies is packaged in saran wrap in a plastic bag with a twist tie, 3 oz (85g). Label is read in parts: "***Heidi's ~~~ Brownies ~~~ *Malted barley wheat flour, cane sugar, water, chocolate chips (unsweetened chocolate, sugar, dextrose, soy lecithin (an emulsifier)(may
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0783-2021·2021-07-28

    Pow Pow Powders Mocha Latte Recall for Undeclared Milk Allergen

    San Diego Coffee, Tea and Spice is recalling Pow Pow Powders Mocha Latte because the product lacks ingredient and allergen labeling and contains undeclared milk.

    Product
    Pow Pow Powders: A standard of Quality Mocha Latte; NET Wt. 3.50 lb. (1.59kg) Ingredients: Sugar, Non-Dairy Creamer (coconut oil, Corn Syrup Solids, Sodium Caseinate (a milk derivative), Sodium Citrate, Mono and Diglycerides, Salt and sodium Aluminosilicate), Non-Fat Dry Milk,
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2104-2021·2021-07-28

    DJO Surgical EMPOWR 3D Knee Tibial Insert packaging may contain wrong implant size

    Packaging for DJO Surgical EMPOWR 3D Knee Tibial Insert knee prosthesis implants may be mislabeled, with 12mm packages potentially containing 16mm implants or vice versa, risking incorrect surgical implantation.

    Product
    DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0785-2021·2021-07-28

    Pow Pow Powders Hot Cocoa Mix Recalled for Undeclared Milk Allergen

    San Diego Coffee, Tea and Spice is recalling Pow Pow Powders hot cocoa mix because the product lacks ingredient and allergen labeling, with undeclared milk present in the formulation.

    Product
    Pow Pow Powders: A standard of Quality Hot Cocoa Mix; NET Wt. 3.50 lb. (1.59kg) Ingredients: Sugar, Non-Dairy Creamer (coconut oil, Corn Syrup Solids, Sodium Caseinate (a milk derivative), Sodium Citrate, Mono and Diglycerides, Salt), Cocoa (processed with alkali) Non-Fat Dry
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0782-2021·2021-07-28

    Pow Pow Powders Spice Chai Recall: Undeclared Milk Allergen

    San Diego Coffee, Tea and Spice is recalling Pow Pow Powders Spice Chai because the product lacks required ingredient and allergen labeling, with milk present but undeclared. Consumers with milk allergies are at risk.

    Product
    Pow Pow Powders: A standard of Quality Spice Chai; NET Wt. 3.50 lb. (1.59kg) Ingredients: Sugar, Non-Dairy Creamer (coconut oil, Corn Syrup Solids, Sodium Caseinate (a milk derivative), Sodium Citrate, Mono and Diglycerides, Salt and sodium Aluminosilicate), Non-Fat Milk, Insta
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2091-2021·2021-07-28

    Backflush Brush Needles Recalled Due to Incorrect Gauge Labeling

    Dutch Ophthalmic USA is recalling Disposable Replacement Backflush Brush Needles (lot 3420011396) distributed in IL, IN, MO, and PA because the label incorrectly identifies the gauge as 20 gauge/0.9mm when the product is actually 23 gauge/0.6mm.

    Product
    Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is 1281.B1D06
    Category
    Medical Device
    Distribution
    4 states
  • LowFDA (Drugs)·D-0665-2021·2021-07-28

    Acetaminophen Extra Strength tablets recalled for incorrect enteric-coated labeling

    LNK International is recalling Acetaminophen Extra Strength coated tablets because the primary label incorrectly states "enteric coated" when the tablets are not enteric coated and should be labeled as standard coated tablets.

    Product
    Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 Coated Tablets/ 500 mg each, Distributed by Amerisource Bergen, 1300 Morris Drive, Chesterbrook, PA, 19087, NDC 46122-649-71
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-0781-2021·2021-07-21

    Living Free Nerve & Muscle Plus Supplement Recalled for Undeclared Soy

    Bea Lydeckers Naturals Inc is recalling Living Free Nerve & Muscle Plus Cetyl-Myristoleate supplement because the label declares lecithin but does not declare that the lecithin is soy-derived, posing a risk to consumers with soy allergies.

    Product
    Living Free Nerve & Muscle Plus Cetyl-Myristoleate Herbal and Glandular Supplement, 180 and 500 capsules per bottles. Product is packed in white, HDPE plastic bottles with threaded HDPE lids. Label is read in parts: "***Living Free Nerve & Muscle Plus Cetyl-Myristoleate ***
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0776-2021·2021-07-21

    Living Free Adult Extra Multi-Vitamin Recall for Undeclared Soy

    Bea Lydeckers Naturals Inc is recalling Living Free "Adult Extra" multi-vitamin capsules because the label declares lecithin but does not declare that it is soy lecithin, posing a risk to consumers with soy allergies.

    Product
    Living Free "Adult Extra" multi-vitamin, 100 or 500 capsules per bottle. Product is packed in white, HDPE plastic bottles with threaded HDPE lids. Label is read in parts: "**Living Free Adult Extra***Natural Vitamin Mineral Herbal Glandular Supplements***Formulated and Manu
    Category
    Food
    Distribution
    Distributed nationwide