The Recall Desk

Hazard

Mislabeling recalls

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

What the numbers show

Total
395
Critical
20
Severe
45
Most recent
2026-07-22

Of the 395 mislabeling recalls we have scored against our rubric, 20 (5%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 45 (11%) 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 mislabeling 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.

201–225 of 395

  • HighFDA (Food)·F-0034-2025·2024-10-23

    Bevi Flavor#115 Electrolytes Recalled: Mislabeled, Contains Caffeine

    Hydration Labs Inc. is recalling Flavor#115 Electrolytes (3.78L BIB units) distributed nationwide and in Canada because the product is labeled as electrolytes but actually contains caffeine.

    Product
    Flavor#115 Electrolytes, Net Contents 3.78L, #740-0115, GTIN barcode 00850010449043. Product is packaged as a Bag In Box (BIB) single unit for use in Bevi Smart Water Cooler machines dispensing flavored waters.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0120-2025·2024-10-23

    Medline Heart Overhead Table Pack recalled for incorrect model labeling

    Medline Industries recalls Heart Overhead Table Packs due to incorrect labeling. Some kits were marked as model 30000 when they should be model 30001.

    Product
    MEDLINE HEART OVERHEAD TABLE PACK, REF DYNJ0778508J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3190-2024·2024-10-02

    Prelude Sheath Introducer 7.5F devices recalled due to labeling error

    Merit Medical Systems is recalling 1,892 Prelude Sheath Introducer devices due to a labeling error: devices labeled as 7.5F are actually sized as 7F. The dimensional mislabeling could result in incorrect device selection during medical procedures.

    Product
    Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3171-2024·2024-09-25

    K-Wire Packaging Error Recall by Smith & Nephew

    Smith & Nephew issued a voluntary recall of K-Wire bone fixation fasteners due to a packaging error where packages contained the wrong wire diameter than labeled.

    Product
    DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3128-2024·2024-09-18

    Medtronic Venous Cannulae: Wrong Product in Incorrect Packaging

    Medtronic Perfusion Systems is recalling 290 units of DLP Single Stage Venous Cannulae due to a manufacturing error where straight-tip cannulae were placed into packaging labeled for right-angle metal-tip cannulae.

    Product
    Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3133-2024·2024-09-18

    Biolox Taper Sleeve Mislabeling: Wrong Component Size in Hip Replacement

    Zimmer GmbH is recalling Biolox Option Taper Sleeves due to mislabeling where packaging labels one neck size but contains the opposite size. These components are used in hip replacement surgery.

    Product
    Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1064
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2947-2024·2024-09-11

    BD Pyxis QFill Medication Cabinet Software Issue Causes Incorrect Bin Labeling

    A software bug in BD Pyxis QFill medication cabinet systems may print incorrect medication bin labels during restocking, potentially causing medication errors. Three units are affected.

    Product
    BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2638-2024·2024-08-21

    PICC Catheter Package Contains Wrong Length, Causing Procedural Delay

    Argon Medical Devices recalls PICC catheters that are mislabeled. Packages marked 26G/1.9Fr x 30cm actually contain 26G/1.9Fr x 50cm catheters, which could delay procedures.

    Product
    L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0631-2024·2024-08-14

    Acetaminophen tablets incorrectly labeled with aspirin drug facts information

    Some bottles of Acetaminophen Extra Strength 500 mg tablets are labeled with the drug facts information for Aspirin 81 mg tablets. The affected lot is 4138197 (expiration 10/31/2025), distributed nationwide.

    Product
    ACETAMINOPHEN — ACETAMINOPHEN (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1647-2024·2024-08-14

    SAVPAK Duro Rueda 8oz Contains Undeclared Wheat Allergen

    SAVPAK Duro Rueda 8oz packages distributed in Texas contain undeclared wheat allergen. Consumers with wheat allergies or celiac disease should not consume this product.

    Product
    SAVPAK Duro Rueda 8oz, plastic bag, DISTRIBUTED BY: Southcoast Produce Inc. Dallas, Texas 75215; UPC 29661 00073
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1640-2024·2024-08-14

    Lunds & Byerlys Caesar Salad Recalled for Undeclared Shellfish and Allergens

    Lunds & Byerlys is recalling Grilled Chicken Caesar Salad that is mislabeled; it is actually Korean Shrimp Salad containing undeclared shellfish, tree nuts (cashew), soybeans, and sesame. Distributed in Minnesota, Lot 301335, Use By 12/04/23.

    Product
    Lunds & Byerlys grilled chicken caesar salad, Net Wt: 9.0 oz. (255.2g) UPC 0 18169-66428 5. Lunds & Byerlys, Edina, MN 55424
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0629-2024·2024-08-14

    Methotrexate tablets may contain wrong medication, FDA says

    Amneal Pharmaceuticals recalls Methotrexate 2.5mg tablets (Lot BB29124) distributed nationwide due to potential presence of Fludrocortisone Acetate tablets. Patients should verify their lot number with their pharmacy.

    Product
    Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1491-2024·2024-07-31

    Universal Bakery Organic Sunrise Energy Bars recalled for undeclared gluten

    Universal Bakery Organic Sunrise Energy Bars labeled as gluten-free but found to contain gluten above FDA limits. The product poses a risk to consumers with celiac disease or gluten sensitivity.

    Product
    Universal Bakery Organic Sunrise Energy Bars 32 oz. and 10 oz. Gluten Free USDA Organic Made With: Rolled Oats, Dried Fruits, Flax Seeds, Quinoa, Coconut, Pumpkin Seeds, Chia Seeds + More Ingredients: Organic Rolled Oats, Organic Sunflower Oil, Organic Evaporated Cane Juice, Or
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Drugs)·D-0614-2024·2024-07-31

    Nature's Script CBD Pain Relief Roll-On Recalled for Subpotent Menthol

    FDA Class III recall of Nature's Script CBD Cryotherapy Pain Relief Roll-on (200mg, 1 oz bottles) due to subpotent menthol content less than the labeled 4%. The product did not contain the claimed amount of active ingredient.

    Product
    Nature's Script CBD Cryotherapy Pain Relief Roll on (menthol 4%) 200mg, 1 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634, UPC code: 8-40078-56731-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2371-2024·2024-07-24

    Hip Prosthesis Component Mislabeled; Package Size May Not Match Device

    Howmedica Osteonics is recalling 18 units of UNITRAX Endoprosthesis Head Components due to mislabeled package sizes. The label may not match the actual device size inside.

    Product
    UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-042
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2405-2024·2024-07-24

    Zimmer Tourniquet Cuff Recalled Due to Incorrect Port Configuration Labeling

    Stryker is recalling 90 units of Zimmer Tourniquet Cuff 30" because packaging labels them as dual port single bladder, but they actually contain a single port single bladder configuration.

    Product
    REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2267-2024·2024-07-10

    Prostate Treatment Balloons Recalled Due to Fill Volume Mislabeling

    Angiodynamics is recalling IsoLoc Prostate Immobilization Balloons (ISO-100, Lot 5402) for mislabeling. Devices have 100cc fill volume but are labeled as ISO-60 (60cc).

    Product
    IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1391-2024·2024-07-03

    ELV Control Herbal Supplement Recalled for Containing Toxic Yellow Oleander

    ELV Control Herbal Supplement is being recalled because it contains yellow oleander instead of the labeled tejocote ingredient. Yellow oleander is toxic to humans. The product was distributed through authorized dealers and e-commerce platforms.

    Product
    ELV Control Herbal Supplement; 90 Capsules
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1428-2024·2024-07-03

    Cream Cheese Stuffed Mini Bagels Recalled for Undeclared Gluten

    FEEL GOOD FOODS INC is recalling Cream Cheese Stuffed Everything Mini Bagels nationwide because the product contains gluten not listed on the label. Consumers with gluten sensitivity should not consume this product.

    Product
    Cream Cheese Stuffed Everything Mini Bagels
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2133-2024·2024-06-19

    Stimuplex A Anesthesia Needles Recalled for Undisclosed DEHP in Glue

    B Braun Medical Inc is recalling 108,811 units of Stimuplex A anesthesia needles because the devices are labeled as DEHP-free but the glue contains traces of DEHP.

    Product
    Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2134-2024·2024-06-19

    Stimuplex A Nerve Needles Recalled for Mislabeled DEHP Content

    B Braun Medical Inc is recalling over 1.1 million Stimuplex A nerve block needles labeled as DEHP-free, but the adhesive contains traces of DEHP. The mislabeling poses a risk to users who selected the product specifically to avoid DEHP exposure.

    Product
    Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0544-2024·2024-06-12

    TIVICAY HIV medication carton mislabeled with incorrect expiration date

    GlaxoSmithKline recalls TIVICAY cartons nationwide with incorrect expiration date on packaging. The carton label shows May 2026, but the correct expiration on the bottle is April 2025.

    Product
    TIVICAY — TIVICAY (DOLUTEGRAVIR SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1874-2024·2024-05-29

    FDA Recalls Prelude Guide Sheath Roadster for Component Size Mismatch

    Merit Medical Systems is recalling 18 units of Prelude Guide Sheath Roadster due to sheaths labeled as .018 dilators potentially containing .038 dilators instead. The mismatch poses a risk if the wrong-sized component is used during medical procedures.

    Product
    Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1222-2024·2024-05-15

    Dietary Supplement Labeling Error: Kirkman 5-MTHF Folic Acid Misdeclared

    Kirkman 5-MTHF dietary supplement has a labeling error: the Supplement Facts incorrectly states 5000mcg Folic Acid per serving instead of 1000mcg. Lot# 477-0016, exp. 08/2025.

    Product
    Kirkman brand 5-MTHF Methyltetrahydrofolate 1mg capsule dietary supplement, Folate 1667mcg DFE, 5000mcg Folic Acid, 120 capsules per package, UPC 8 12325 02354 7. Manufactured exclusively by: Kirkman, Lake Oswego, OR 9703,
    Category
    Drug
    Distribution
    7 states
  • HighFDA (Food)·F-1176-2024·2024-05-01

    Teriyaki Salmon Recalled Due to Mislabeling as Chicken

    Taylor Farms Southwest is recalling 6 packages of Ready Meals Teriyaki Salmon that were mislabeled as Teriyaki Chicken, posing a risk for consumers with fish allergies.

    Product
    Ready Meals Teriyaki Salmon W Rice 13.5OZ TRAY BLK&GOLD ALUM 22OZ with Plastic Lid #81061425 UPC: 002113010092 Sell Thru 04/12/24 LOT TFSW095A
    Category
    Food
    Distribution
    0 states