The Recall Desk

Hazard

Labeling Error recalls

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

What the numbers show

Total
536
Critical
17
Severe
21
Most recent
2026-07-22

Of the 536 labeling error recalls we have scored against our rubric, 17 (3%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 21 (4%) 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 labeling error 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.

1–25 of 536

  • ModerateFDA (Devices)·Z-2729-2026·2026-07-22

    Orthofix MINIRAIL external fixation devices recalled for incorrect model labeling

    Orthofix U.S. LLC is recalling Orthofix MINIRAIL external fixation devices (Model M101) because they may be labeled with incorrect model numbers, potentially leading to use of wrong device specifications.

    Product
    Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Food)·H-1152-2026·2026-07-22

    Liquid Hope Organic Meal Replacement Formula Subpotent Vitamin A Recall

    Nutricia North America is recalling Liquid Hope Organic Whole Foods Meal Replacement Peptide Formula Berry Medley because the product contains less vitamin A than labeled. A testing laboratory used an incorrect method that overstated the vitamin A concentration.

    Product
    functional formularies LIQUID HOPE ORGANIC WHOLE FOODS MEAL REPLACEMENT PEPTIDE FORMULA BERRY MEDLEY NET WT. 12 OZ (341g) case UPC 8 57858 00453 3, package UPC 8 57858 00450 2
    Category
    Food
    Distribution
    49 states
  • HighFDA (Drugs)·D-0628-2026·2026-07-01

    Perampanel Prescription Tablets Recalled for Labeling Mix-up

    Sun Pharmaceutical is recalling Perampanel 6 mg tablets due to labeling mix-up where 10 mg tablets were found in bottles labeled as 6 mg. Patients should verify their bottles with their pharmacy or physician.

    Product
    PERAMPANEL — PERAMPANEL (PERAMPANEL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-1075-2026·2026-06-24

    Azuma Foods Tako Wasabi seasoned octopus contains undeclared fish

    Azuma Foods Tako Wasabi Seasoned Octopus with Wasabi is being recalled because of undeclared fish. The action covers 545 retail cases and 3,616 foodservice cases.

    Product
    azuma foods TAKO WASABI Seasoned Octopus with Wasabi PERISHABLE/KEEP FROZEN PRODUCT OF JAPAN DISTRIBUTED BY: AZUMA FOODS INTERNATIONAL INC., U.S.A. HAYWARD, CA 94545 Retail: 3-50g PACKS NET WT. 5.3 OZ (150g) UPC: 745329900647 Foodservice: 2.2lbs UPC: 745329900746
    Category
    Food
    Distribution
    17 states
  • HighFDA (Food)·H-0947-2026·2026-06-24

    Nutrisystem chocolate cheesecake portions contain undeclared soy allergen

    Nutrisystem Chocolate Cheesecake, 2 oz frozen packages, is being recalled because of undeclared soy. 5,184 units are affected.

    Product
    Nutrisystem, Chocolate Cheesecake, 2 oz (57g) packages, Flow Wrapped, 48 units per case, Keep frozen
    Category
    Food
    Distribution
    26 states
  • HighFDA (Food)·H-1079-2026·2026-06-24

    Adndale magnesium glycinate gummies contain undeclared melatonin in three lots

    Adndale Magnesium Glycinate Gummies 400 mg are being recalled because of undeclared melatonin. The action covers 13,920 bottles.

    Product
    Adndale Magnesium Glycinate Gummies 400 mg. Plastic bottle containing 90 gummies. Net weight: 11.36 ounces. Serving size: 2 gummies. UPC: 860008784551 Firm name and address listed on label: Dkiru Ltd, Keepers Cottage, 3 Dublin Rd, Leixlip, Co. Kildare W23 H3C4, Ireland
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2516-2026·2026-06-24

    Inspire stimulation leads labeled with Use By dates beyond shelf life

    Inspire Stimulation Leads, model 4063, are being recalled because they carry an incorrect Use By Date extending beyond the validated three-year shelf life. 10 units affected.

    Product
    Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The Inspire¿ Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0594-2026·2026-06-24

    Aripiprazole 30mg bottle contained voriconazole 50mg tablets instead

    Aripiprazole Tablets USP 30 mg from Ajanta Pharma are being recalled after a bottle containing Voriconazole Tablets 50 mg was labelled and distributed as aripiprazole. 6,143 bottles affected.

    Product
    ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2515-2026·2026-06-24

    Inspire respiratory sensing leads labeled with Use By dates beyond shelf life

    Inspire Respiratory Sensing Leads, model 4340, are being recalled because they carry an incorrect Use By Date extending beyond the validated three-year shelf life. 50 units affected.

    Product
    Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 Software Version: N/A Product Description: The Inspire¿ Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pres
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2460-2026·2026-06-24

    directCHECK whole blood control labeled with incorrect performance range

    directCHECK ACT-LR whole blood quality control, level 2, is being recalled because the assayed control carries labeling with an incorrect performance range. 6,060 units affected.

    Product
    directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0608-2026·2026-06-24

    Focalin XR 5mg capsules carry incorrect or missing lot and expiry

    Focalin XR 5 mg extended-release capsules are being recalled over a labeling issue: incorrect or missing lot number and/or expiry date. 7,803 bottles are affected.

    Product
    FOCALIN — FOCALIN (DEXMETHYLPHENIDATE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0941-2026·2026-06-17

    Whole Foods vegetarian minestrone soup contains undeclared shrimp allergen

    Whole Foods Market Kitchens Vegetarian Minestrone Soup, 24 oz, is being recalled because it contains undeclared shrimp. 562 cases, or 4,496 units, are affected.

    Product
    Individual Unit Label (both lid and front of cup): Whole Foods Market Kitchens Minestrone Soup, VEGETARIAN NET WT 24 OZ (1 Lb 8OZ) 680g. Case Label: Whole Foods Global Minestrone Soup 702505, KEEP REFRIGERATED, Distributed by Whole Foods Market Austin, TX 78703. Eight (8)/ 24 oz
    Category
    Food
    Distribution
    18 states
  • HighFDA (Devices)·Z-2400-2026·2026-06-17

    Aluminum chloride hemostatic gel kits shipped with wrong package insert

    Advance Aluminum Chloride Gel Clear Hemostatic Gel Kits are being recalled because some units contain the package insert for Ferric Sulfate Gel, which gives different first aid instructions.

    Product
    Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2401-2026·2026-06-17

    Bicarby dialysate bags carry an incorrect GTIN on the label

    Bicarby Dialysate, model RFP-400-G, is being recalled because of an error in the GTIN printed on the product, which could lead to a potassium concentration differing from the prescription.

    Product
    Bicarby Dialysate; Model number: RFP-400-G;
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·H-0940-2026·2026-06-17

    Park St. Deli macaroni and cheese does not declare soy

    Park St. Deli Macaroni & Cheese, 20 oz, is being recalled because of undeclared soy lecithin. The action covers 58,405 cases.

    Product
    Park St. Deli Macaroni & Cheese, NET WT 20 OZ (1 LB 4 OZ) 567g, product packed in plastic tub and placed into paperboard sleeve. 9/20 oz packages per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0915-2026·2026-06-17

    Brazo Gitano caramel sweet rolls contain undeclared synthetic color additives

    Brazo Gitano Caramel Sweet Roll, 24 oz, is being recalled because of undeclared colors: Yellow #5, Yellow #6 and/or Red #40. 2,273 units are affected.

    Product
    Brazo Gitano [image] Caramel Sweet Roll The Original, Net Wt. 24 oz, packaged in a rigid plastic clamshell container with a transparent dome lid and tray base, one unit per container. KEEP REFRIGERATED. UPC 882479852232
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·H-0916-2026·2026-06-17

    Jumbo caramel roll 40 ounce packages contain undeclared color additives

    Jumbo Brazo Gitano Caramelo (Jumbo Caramel Roll), 40 oz, is being recalled because of undeclared colors: Yellow #5, Yellow #6 and/or Red #40. 1,116 units are affected.

    Product
    Jumbo Brazo Gitano Caramelo [image] Jumbo Caramel Roll The Original, Net Wt. 40 oz, packaged in a rigid plastic clamshell container with a transparent dome lid, one unit per container. KEEP REFRIGERATED. UPC 824790852645
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·H-0922-2026·2026-06-17

    Capuchino cake 63 ounce containers hold undeclared synthetic color additives

    Cake de Capuchino, 63 oz, is being recalled because of undeclared colors: Yellow #5, Yellow #6 and/or Red #40. 3,786 units are affected.

    Product
    Cake de Capuchino [image] Capuchino Cake The Original, Net Wt. 63 oz, packaged in a transparent and rigid plastic clamshell container with a transparent dome lid and tray base, one unit per container. KEEP REFRIGERATED. UPC 824790850375
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·H-0934-2026·2026-06-17

    Mango cheesecake 26 ounce containers hold undeclared synthetic color additives

    Cheesecake de Mango, 26 oz, is being recalled because of undeclared colors: Yellow #5, Yellow #6 and/or Red #40. 93 units are affected.

    Product
    Cheesecake de Mango [image] Mango Cheesecake The Original, Net Wt. 26 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852836
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·H-0918-2026·2026-06-17

    Jumbo Napolitano dessert recalled for undeclared Yellow and Red dyes

    Jumbo Napolitano (Jumbo Neapolitan), 26 oz, is being recalled because of undeclared colors: Yellow #5, Yellow #6 and/or Red #40. 2,598 units are affected.

    Product
    Jumbo Napolitano [image] Jumbo Neapolitan, Net Wt. 26 oz, packaged in a rigid plastic clamshell container with a transparent dome lid and tray base, one unit per container. KEEP REFRIGERATED. UPC 824790853086
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·H-0913-2026·2026-06-17

    Estrella passion fruit drink does not declare FD&C Red 40

    Estrella Bebida de Parcha (Passion Fruit Drink) in three sizes is being recalled because of undeclared FD&C Red 40. A total of 2,111 units are affected.

    Product
    ESTRELLA, Bebida de Parcha (Passion Fruit Drink), multiple sizes, 14 OZ.FL. (413 ML), 64 OZ.FL (1,920mL), 120 OZ.FL. (3.54LT.) 14 OZ.FL Plastic Bottles packed in cases of 25 bottles. KEEP REFRIGIRATED.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·H-0932-2026·2026-06-17

    Marquesita chocolate and vanilla cakes contain undeclared synthetic color additives

    Marquesita de Chocolate y Vainilla flavored cakes, 16 oz, are being recalled because of undeclared colors: Yellow #5, Yellow #6 and/or Red #40. 809 units are affected.

    Product
    Marquesita de Chocolate y Vainilla [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852706
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·H-0917-2026·2026-06-17

    Napolitano dessert 22 ounce packages contain undeclared synthetic color additives

    Napolitano (Neapolitan) dessert, 22 oz, is being recalled because of undeclared colors: Yellow #5, Yellow #6 and/or Red #40. 5,960 units are affected.

    Product
    Napolitano [image] Neapolitan The Original, Net Wt. 22 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852256
    Category
    Food
    Distribution
    2 states