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.

7201–7225 of 9611

  • ModerateFDA (Devices)·Z-2069-2014·2014-07-23

    Axcentria Recalls Calcium Hydroxide Powder Due to Missing 510(k) Approval

    Axcentria Pharmaceuticals is recalling one lot of Calcium Hydroxide Powder because it was distributed without FDA approval and lacks usage instructions.

    Product
    Calcium Hydroxide Powder, USP For use in root canal therapy by health care professional. Product Application or Usage: Provides bactericidal effect on carious dentine. Paste delivered to root apex provides pulp insulation. Protects the vital pulp from infections and further de
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2072-2014·2014-07-23

    Integra Recalls Camino ICP Catheters for MRI Safety Labeling

    Integra LifeSciences is recalling Camino Intracranial Pressure Monitoring Kits to update labeling indicating they are unsafe in MR environments.

    Product
    Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat. No's. 110-4B, 110-4G, 110-4H, 110-4L
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-1431-2014·2014-07-23

    Poly Pharmaceuticals Recalls Poly-Tussin AC Liquid Due to Labeling and Specification Issues

    Poly Pharmaceuticals is recalling 208 bottles of Poly-Tussin AC Liquid because phenylephrine levels are below specifications and the label inaccurately states 'Rx Only'.

    Product
    POLY-TUSSIN AC LIQUID, Each 5 mL (1 teaspoonful) contains: Brompheniramine Maleate 4 mg, Codeine Phosphate 10 mg, Phenylephrine HCl 7.5 mg, 16 fl oz. (473 mL) Bottle, Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals,
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1443-2014·2014-07-23

    Pfizer Recalls Viracept Tablets Due to Incorrect Expiration Date Labeling

    Pfizer is recalling Viracept (nelfinavir mesylate) tablets because some bottles were labeled with an incorrect expiration date of 11/2016 instead of 09/2016.

    Product
    VIRACEPT — VIRACEPT (NELFINAVIR MESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1432-2014·2014-07-23

    Poly Pharmaceuticals Recalls Lortuss Ex Due to Labeling and Specification Issues

    Poly Pharmaceuticals is recalling 102 bottles of Lortuss Ex because the product does not meet monograph specifications and has inaccurate labeling.

    Product
    LORTUSS EX, Each 5 mL (1 teaspoonful) contains: Codeine Phosphate 10 mg, Guaifenesin 100 mg, Psuedoephedrine HCl 22.5 mg, 16 fl oz. (473 mL), Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals, Mobile, AL 36619. NDC:
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2041-2014·2014-07-23

    BBL CrystaLEAD E/NF Identification Kits Recalled for Incorrect Expiration Dates

    Becton Dickinson is recalling specific lots of BBL CrystaLEAD E/NF Identification kits because some contain fluid bottles that expire before the date printed on the kit carton.

    Product
    BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in vitro diagnostic for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·047-2014·2014-07-22

    Sara Lee Foodservice Recalls Smoked Sausage Due to Undeclared Soy Allergen

    Sara Lee Foodservice is recalling smoked sausage products because they contain undeclared soy protein, a known allergen. No adverse reactions have been reported.

    Product
    Wisconsin Firm Recalls Sausage Product Due To Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2164-2014·2014-07-16

    Chocolate Ice Cream Recalled for Missing Allergen and Ingredient Labels

    Koogee-Queen Anne, LLC is recalling chocolate ice cream because bulk product lacked labels, failing to declare direct allergens and facility processing information.

    Product
    Chocolate "Chip Off the Old Block" Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2002-2014·2014-07-16

    3M Attest Auto-reader Recalled for Missing Dry Natural Rubber Labeling

    3M is recalling Attest Auto-readers because labels failed to disclose dry natural rubber content, posing an allergy risk.

    Product
    3M Attest Auto-reader. Model numbers 390, 390G,and 490. These devices incubate the biological indicators (BIs) to determine a positive or negative result for the sterilization cycle.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2098-2014·2014-07-16

    Ice Cream Recalled for Missing Allergen and Ingredient Labels

    Koogee-Queen Anne, LLC is recalling Banana Puddin' Y'all Ice Cream because the bulk product lacked labels, failing to declare direct allergens and facility processing information.

    Product
    Banana Puddin' Y'all Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2153-2014·2014-07-16

    Dulce de Leche Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Dulce de Leche de Salte Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Dulce de Leche de Salte Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2157-2014·2014-07-16

    Shirley's Red Velvet Cake Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Shirley's Red Velvet Cake with Cheesecake Swirl Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Shirley's Red Velvet Cake with Cheesecake Swirl Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2140-2014·2014-07-16

    Peaches and Cream Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Peaches and Cream Ice Cream because bulk products lacked labels declaring direct allergens and facility processing of peanuts, tree nuts, wheat, milk, and eggs.

    Product
    Peaches and Cream Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2097-2014·2014-07-16

    Ice Cream Recalled for Missing Allergen and Ingredient Labels

    Koogee-Queen Anne, LLC is recalling Say "Cheeeeeesecake" Ice Cream because bulk product lacked labels declaring ingredients and direct allergens.

    Product
    Say "Cheeeeeesecake" Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2086-2014·2014-07-16

    Ah! Laska Organic Cocoa Mix Recalled for Undeclared Milk Allergen

    Koru Pacific Packaging is recalling Ah! Laska Organic Cocoa Non Dairy Chocolate Mix because internal testing found milk allergen in the product.

    Product
    Ah! Laska Organic Cocoa Non Dairy Chocolate Mix; Low Fat, Vegan, USDA Organic; Net Wt. 12 oz. (340 g); UPC 7-60519-10028-7; Ingredient: Organic cane sugar, organic cocoa powder (non-alkaline) organic, rice syrup solids, xanthan gum (a natural thickener) carrageenan (a natu
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2124-2014·2014-07-16

    Candy Cane Lane Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Candy Cane Lane Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Candy Cane Lane Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2134-2014·2014-07-16

    Gin and Juice Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Gin and Juice Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Gin and Juice Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2096-2014·2014-07-16

    Erica's PB&J Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Erica's PB&J Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Erica's PB&J Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2139-2014·2014-07-16

    Mexican Chocolate Ole Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Mexican Chocolate Ole Ice Cream because the bulk product lacked labels declaring direct allergens and facility processing information.

    Product
    Mexican Chocolate Ole Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2094-2014·2014-07-16

    Cake Batter Up Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Cake Batter Up Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Cake Batter Up Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2148-2014·2014-07-16

    Watermelon Mint Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Watermelon Mint Ice Cream because the bulk product lacked labels declaring direct allergens and facility processing information.

    Product
    Watermelon Mint Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2110-2014·2014-07-16

    Lime Pie Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling lime pie ice cream because bulk products lacked labels declaring direct allergens and facility processing of peanuts, tree nuts, wheat, milk, and eggs.

    Product
    Key To My Heart Lime Pie Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2118-2014·2014-07-16

    Banana Nana Fofana Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Banana Nana Fofana Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Banana Nana Fofana Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2111-2014·2014-07-16

    Lemon Cream Raspberry Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Lemon Cream Raspberry Ice Cream because the bulk product lacked labels declaring direct allergens and facility processing information.

    Product
    Lemon Cream Raspberry Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2100-2014·2014-07-16

    Blue Cheese Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Blue Cheese Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Blue Cheese Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states