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.

Which agencies issued them

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.

2876–2900 of 9607

ModerateFDA (Devices)·Z-1108-2019·2019-04-17
Conformis Recalls Two iTotal CR Total Knee Replacement Systems
Conformis, Inc. is recalling two iTotal CR Total Knee Replacement Systems prepared with incorrect patient ID labels and potentially incorrect components.
Product
iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (Model No.) Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disabil
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1131-2019·2019-04-17
Lohxa Recalls Phenobarbital Oral Solution Due to Incorrect Expiration Date
Lohxa LLC is recalling Phenobarbital Oral Solution because the labels contain incorrect expiration dates. The affected product was distributed in Massachusetts, New York, and Wyoming.
Product
Phenobarbital Oral Solution, USP 20 mg/5mL, unit dose cup, Rx Only, Rpkg. By.Lohxa Worcester, MA 01608 NDC 70166-536-02
Category
Drug
Distribution
3 states
ModerateFDA (Drugs)·D-1130-2019·2019-04-17
Lohxa Recalls Bismuth Subsalicylate Suspension Due to Incorrect Expiration Date
Lohxa LLC is recalling Bismuth Subsalicylate Oral Suspension because the labels contain incorrect expiration dates. The affected product was distributed in Massachusetts, New York, and Wyoming.
Product
Bismuth Subsalicylate Oral Suspension 262mg/15mL, unit dose cups, OTC, Rpkg. By.: Lohxa Worcester, MA, NDC 70166-059-01
Category
Drug
Distribution
3 states
ModerateFDA (Drugs)·D-1113-2019·2019-04-17
Gavilyte-N Recalled for Incorrect Flavor Labeling on Orange and Cherry Packets
Lupin Somerset is recalling Gavilyte-N because orange and cherry flavor packets incorrectly list 'natural lemon flavor' as an ingredient.
Product
GAVILYTE-N — GAVILYTE-N (POLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1084-2019·2019-04-17
X-Gen Recalls Clonidine Injection Vials Due to Labeling Error
X-Gen Pharmaceuticals is recalling Clonidine HCL Injection vials because the side carton incorrectly lists the concentration as 500 mcg instead of 100 mcg per mL.
Product
CLONIDINE — CLONIDINE (CLONIDINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1118-2019·2019-04-17
Arrow Two-Lumen Central Venous Catheterization Kit Recalled for Labeling Error
Arrow International Inc is recalling specific lots of Two-Lumen Central Venous Catheterization Kits because the lidstock displays an incorrect priming volume.
Product
Arrow¿ Two-Lumen Central Venous Catheterization Kit with Blue FlexTip¿ Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132
Category
Medical Device
Distribution
2 states
LowFDA (Devices)·Z-1106-2019·2019-04-17
Randox Immunoassay Controls Recalled for Incorrect Analyzer Target Value
Randox Laboratories is recalling Immunoassay Premium Plus Controls due to an incorrect target value listed on the analyzer value sheet.
Product
Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert
Category
Medical Device
Distribution
2 states
LowFDA (Devices)·Z-1105-2019·2019-04-17
Randox Immunoassay Premium Controls Recalled for Incorrect Analyzer Target Values
Randox Laboratories is recalling 58 units of Immunoassay Premium Controls due to an incorrect target value listed on the analyzer value sheet.
Product
Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert
Category
Medical Device
Distribution
2 states
LowFDA (Devices)·Z-1107-2019·2019-04-17
Randox Liquid Immunoassay Premium Controls Recalled for Incorrect Target Value
Randox Laboratories is recalling Liquid Immunoassay Premium Controls because the target value for uptake is incorrect on the value sheet.
Product
Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert
Category
Medical Device
Distribution
2 states
LowFDA (Drugs)·D-1082-2019·2019-04-17
Auro Pharmacies Recalls Biotin Injection Vials for pH Failure
Auro Pharmacies Inc. is recalling 167 vials of Biotin 10 mg/mL Injection because the product failed to meet its pH label claim.
Product
Biotin 10 mg/mL Injection, 30 mL vial, Rx only, 511 S. Harbor Blvd., Building. F, La Habra, CA 90631, 562-352-9630.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1232-2019·2019-04-10
Century Snacks Recalls Honey Bliss Nut Mix for Undeclared Milk Allergen
Century Snacks LLC is recalling Snak Club Honey Bliss Nut Mix because the Honey Butter Seasoning contains milk, a major allergen, that was not declared on the packaging.
Product
Snak Club Honey Bliss Nut Mix: Honey Butter Flavored Almonds, Peanuts, Pumpkin Seeds, Pistachios, Pecans & Honey Sesame Sticks. NET WET,3-oz. and 5.75-oz plastic pouches and 25 lb. bulk bags 3 oz. UPC: 0 87076 21152 3, 5.75 oz. UPC: 0 87076 51152 4
Category
Food
Distribution
30 states
HighFDA (Devices)·Z-1086-2019·2019-04-10
Zimmer Biomet Recalls RingLoc Hip System Bone Screws Due to Packaging Error
Zimmer Biomet is recalling 809 units of RingLoc Hip System Self-Tapping Bone Screws because 30mm screws may have been packaged as 20mm screws, and vice versa.
Product
Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Titanium. Accessory to total hip implant Item Number: 103531 Product Usage: Accessory to total hip implant
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1087-2019·2019-04-10
Zimmer Biomet Recalls RingLoc Hip System Self-Tapping Bone Screws
Zimmer Biomet is recalling 809 units of RingLoc Hip System Self-Tapping Bone Screws due to a potential packaging error where 30mm screws may be labeled as 20mm and vice versa.
Product
Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx30mm-Low Profile Titanium, Accessory to total hip implant Item Number: 103533 Product Usage: Accessory to total hip implant
Category
Medical Device
Distribution
Distributed nationwide
ModerateUSDA FSIS·045-2019·2019-04-10
Yoakum Packing Recalls Venison Sausage Due to Pork Mislabeling
Yoakum Packing Co. is recalling smoked venison sausage that contains pork not listed on the label. The recall affects products sold in Texas.
Product
Yoakum Packing Co. — Yoakum Packing Co. Recalls Venison Sausage Products Due to Mislabeling
Category
Food
Distribution
1 state
ModerateFDA (Devices)·Z-1079-2019·2019-04-10
Conformis Recalls Two iTotal Knee Replacement Systems for Labeling Errors
Conformis, Inc. is recalling two iTotal Posterior Stabilized Knee Replacement Systems because the box and sterile pouch labels did not match the contents.
Product
iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
Category
Medical Device
Distribution
1 state
ModerateFDA (Food)·F-1230-2019·2019-04-10
Snow's Mint Chip Ice Cream Recalled for Undeclared Yellow #5 Dye
Snow's Acquisition, LLC is recalling Mint Chip Ice Cream with Dark Chocolate Chunks because the product contains undeclared Yellow #5 dye.
Product
Snow's PREMIUM ICE CREAM Mint Chip Mint Ice Cream with Dark Chocolate Chunks 1.5 QUART (1.42L) KEEP FROZEN, UPCE: 0 48896400139
Category
Food
Distribution
1 state
ModerateFDA (Drugs)·D-1078-2019·2019-04-10
KRS Global Biotechnology Recalls Repinephrine IV Bags Due to Labeling Error
KRS Global Biotechnology is recalling 190 bags of Repinephrine 16 mg IV solution due to a label mix-up. The product was distributed nationwide.
Product
NORepinephrine 16 mg added to 0.9% Sodium Chloride (PF), 16 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnology: 791 Park of Commerce Blvd., Boca Raton, FL 33487. NDC 3321678343
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1079-2019·2019-04-10
KRS Global Biotechnology Recalls NORepinephrine IV Bags Due to Labeling Error
KRS Global Biotechnology is recalling 433 bags of NORepinephrine 4 mg in 5% Dextrose due to a label mix-up. The product was distributed nationwide.
Product
NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag (PF), 4 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnology: 791 Park of Commerce Blvd., Boca Raton, FL 33487. NDC 3321674481
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1080-2019·2019-04-10
McKesson Consult Diagnostic Fecal Occult Blood Test Recalled for Packaging Issues
Cypress Medical Products LLC is recalling McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Tests because the packaging is too similar to other products, leading to a denial of CLIA waiver approval.
Product
McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numbers 178-CK30T, 178-CT30, 178¿TBSO, 178-CM25, 178-CK50, 178-CM50, 178-CT50, 178¿CK30
Category
Medical Device
Distribution
27 states
LowFDA (Devices)·Z-1088-2019·2019-04-10
Beaver Visitec Recalls Micro Knife 5.0mm Due to Misprinted Expiration Date
Beaver Visitec is recalling 97 boxes of Micro Knife 5.0mm 30° instruments because the expiration date was misprinted as the lot number.
Product
Micro Knife 5.0mm 30¿, Part Number 0001522 The Beaver¿ Micro Knife 5.0mm 30¿ is a sharp pointed tip intended for ophthalmic, ENT and other forms of surgery stab incisions and other microsurgical techniques. .
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1278-2019·2019-04-03
Surtidoras Bakery Recalls Kid's Rainbow Cookies for Allergen Labeling Error
Surtidoras Bakery is recalling 50 packages of Kid's Rainbow Cookies because the packaging failed to declare coconut as an allergen in the 'Contains' statement.
Product
Kid's Rainbow Cookies, brand Surtidoras Bakery, net wt.15.52 oz., packaged in rigid plastic clam shell container. No UPC. The allergens declared in the INGREDIENTS statement: "***ENRICHED WHEAT FLOUR BLEACHED*** SOYBEAN OIL***SOY LECITHIN ***MILK FAT***MODIFIED COCONUT OIL***
Category
Food
Distribution
1 state
HighFDA (Food)·F-1282-2019·2019-04-03
Surtidoras Bakery Marble Muffin Recalled for Undeclared Milk Allergen
Surtidoras Bakery is recalling 21 packages of Marble Muffins because the ingredients list includes whey but fails to declare milk as an allergen.
Product
Marble Muffin, brand Surtidoras Bakery, net wt. 1.74 lbs., packaged in rigid plastic clam shell container. No UPC. The allergens declared in the INGREDIENTS statement: "***ENRICHED WHEAT FLOUR *** SOYBEAN OIL***EGGS***SOY LECITHIN ***WHEY***SOYBEAN OIL AND WHOLE EGGS***". T
Category
Food
Distribution
1 state
HighFDA (Food)·F-1281-2019·2019-04-03
Surtidoras Bakery Recalls Vanilla Muffins Due to Undeclared Milk Allergen
Surtidoras Bakery Inc is recalling 40 packages of Vanilla Muffins distributed in Washington because the packaging failed to declare milk in the 'Contains' statement.
Product
Vanilla Muffin, brand Surtidoras Bakery, net wt. 1.74 lbs., packaged in rigid plastic clam shell container. No UPC. The allergens declared in the INGREDIENTS statement: "***UNBLEACHED WHEAT FLOUR *** SOY LECITHIN ***HOMOGENIZED AND PASTEURIZED MILK 2% REDUCE FAT MILK ***SOYBEA
Category
Food
Distribution
1 state
HighFDA (Food)·F-1280-2019·2019-04-03
Surtidoras Bakery Recalls Vanilla Pound Cake for Undeclared Milk Allergen
Surtidoras Bakery Inc is recalling 60 packages of Vanilla Pound Cake because the packaging failed to declare milk in the 'Contains' statement, despite listing it in the ingredients.
Product
Vanilla Pound Cake, brand Surtidoras Bakery, net wt. 15 oz., packaged in flexible plastic film wrap. No UPC. The allergens declared in the INGREDIENTS statement: "***UNBLEACHED WHEAT FLOUR *** SOYBEAN OIL***SOY LECITHIN ***HOMOGENIZED AND PASTEURIZED MILK 2% REDUCE FAT MILK **
Category
Food
Distribution
1 state
HighFDA (Food)·F-1185-2019·2019-04-03
Utz Recalls Bachman Pretzels Due to Undeclared Milk Allergen
Utz Quality Food is recalling Bachman Original Twist Pretzels because butter pretzels were mistakenly packaged in regular pretzel bags, creating an undeclared milk allergen hazard.
Product
Bachman Original Twist Pretzels,10 oz.Bag (flexible film) UPC: 0-77817-10580-8
Category
Food
Distribution
12 states