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.

351–375 of 536

  • HighFDA (Food)·H-0455-2025·2025-08-20

    Quinoa chia soda biscuits recalled for undeclared whole milk powder and wheat

    Soda Biscuit (Quinoa Chia Seed Flavor), 360 g packages imported by Shang Hao Jia, Inc., is recalled because the label does not declare whole milk powder and wheat. 4,800 units are affected.

    Product
    Soda Biscuit (Quinoa Chia Seed Flavor), Net Wt: 360g/12.07oz; Shelf life: 10 months; Manufacturer: Zhejiang Dinggian Industrial Co., Ltd. Importer: Shang Hao Jia., Inc. UPC: 6 970425 865048
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·H-0454-2025·2025-08-20

    Imported soda biscuits recalled for undeclared whole milk powder and wheat

    Soda Biscuit (Sea Salt Fresh Milk Flavor), 360 g packages imported by Shang Hao Jia, Inc., is recalled because the label does not declare whole milk powder and wheat. 4,800 units are affected.

    Product
    Soda Biscuit (Sea Salt Fresh Milk Flavor), Net Wt: 360g/12.07oz; Shelf life: 10 months; Manufacturer: Zhejiang Dinggian Industrial Co., Ltd. Importer: Shang Hao Jia., Inc. UPC: 6 970425 865031
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0542-2025·2025-08-06

    Amlodipine and benazepril capsules released with the wrong expiry date

    Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg are being recalled because they were released with the wrong expiry date, printed as February 2027 instead of January 2027. 7,668 bottles affected.

    Product
    AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE — AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0517-2025·2025-07-23

    Compounded testosterone pellet vials carry incorrect lot numbers from printing issue

    Compounded Testosterone 200 mg Pellet in 1 mL amber vials is being recalled because a printing issue resulted in incorrect lot numbers on the label. 2,832 vials are affected.

    Product
    Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol Park Blvd Edmond OK 73013, NDC 69761-202-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2099-2025·2025-07-16

    Canturio smart tibial stem extensions recalled over an incorrect product label

    Canturio Smart Extension CSE Implants are being recalled due to a labeling error, with the product incorrectly labeled. 106 units are affected.

    Product
    Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem extension for use with Zimmer Persona¿ Personalized Knee System; 14mm diameter x 30mm height. Implantable device with integrated electronics fo
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2100-2025·2025-07-16

    Hummingbird stimulated EMG kit packaging shows the wrong part number

    The Hummingbird Stimulated EMG Kit is being recalled because the product packaging contains the wrong part number and kit contents. 10 units are affected.

    Product
    Brand Name: Hummingbird Product Name: Stimulated EMG Kit with Hummingbird - Model/Catalog Number: REF I-D-BMF90, 1 Single-Use Bipolar Minifork Stimulation Probe, 90mm, and 1 Green Ground Needle ; REF 1-D-BMF90-5, lot number 050925219, expiration 2028-11-30 I-D-BMF90-5 Stim
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2089-2025·2025-07-09

    ADVIA Hematology System Control Product Recall for Platelet Value Error

    Siemens Healthcare Diagnostics is recalling 3,266 units of ADVIA 120/2120/2120i 3-in-1 TESTpoint Control worldwide due to incorrect platelet value assignments that could affect test results.

    Product
    ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1976-2025·2025-06-25

    AcoSound LW12-BTE-M Hearing Aid Labeling and UDI Information Errors

    Hangzhou AcoSound Technology Co., Ltd. is recalling 120 units of the AcoSound Model LW12-BTE-M hearing aid due to labeling errors, including incorrect manufacturer attribution, missing manufacturer business address, and incomplete UDI information.

    Product
    AcoSound. Model Number: LW12-BTE-M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·H-0009-2025·2025-06-11

    Best Taste Brand Salted Shrimp Paste Sauce Recalled for Undeclared FD&C Red #3

    Best Taste Brand Salted Shrimp Paste Sauce (12 oz) is recalled because it contains undeclared FD&C Red #3, a food coloring that is not listed on the label.

    Product
    Best Taste Brand Salted Shrimp Paste Sauce; ING: Shrimp, sugar, salt; COUNTRY FAVOR, INC; PRODUCT OF VIETNAM; Net Weight: 12 oz (350 g)
    Category
    Food
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-1754-2025·2025-05-21

    BIB Balloon in Balloon Dilatation Catheter labeling error recalled

    Numed Inc is recalling BIB Balloon in Balloon Dilatation Catheter Model Number 420 due to incorrect labeling of balloon inflation hubs. The inner and outer balloon labels are swapped, which could lead to improper device use.

    Product
    BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1728-2025·2025-05-14

    Artix MT Thrombectomy Device recalled for incorrect vessel range specification

    Inari Medical is recalling 45 units of the Artix MT Thrombectomy Device (REF: 32-102, Lot 24100082) because labeling specifies an incorrect vessel range of 2.5-6 mm instead of 3-6 mm, which could increase radial force on arteries and cause vascular complications.

    Product
    Artix MT Thrombectomy Device, REF: 32-102
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1718-2025·2025-05-14

    Bio 1 Granules for Filling implant bone graft material nationwide recall

    Bio 1 Granules for Filling implant bone granules may contain less product than specified on the label. The affected lot is 240781 (UDI: 03760154000369), distributed nationwide.

    Product
    Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1671-2025·2025-04-30

    Straumann WB XL Anatomic Healing Abutment XC Dental Implants

    Straumann USA LLC is recalling 1,786 units of WB XL Anatomic Healing Abutment XC endosseous dental implant abutments due to incorrect blister labeling. The product was distributed worldwide.

    Product
    WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0365-2025·2025-04-23

    Levetiracetam Injection Label Mismatch Nationwide Recall

    Dr. Reddy's Laboratories is recalling Levetiracetam 0.75% Sodium Chloride Injection due to a labeling discrepancy where the infusion bag is incorrectly labeled as 0.82% Sodium Chloride 500 mg/100 mL instead of the correct 0.75% Sodium Chloride 1,000 mg/100 mL.

    Product
    LEVETIRACETAM — LEVETIRACETAM (LEVETIRACETAM INJECTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0712-2025·2025-04-23

    Lemon Plum product recall due to undeclared cyclamates

    Rong Shing Trading NY Inc is recalling Lemon Plum (228g) because the product contains cyclamates, which are not declared on the label.

    Product
    LEMON PLUM; NET WT: 228G (8oz); INGREDIENTS: Plum, sugar, salt, lemon juice, food additives (citric acid, sodium benzoate, potassium sorbate, ethyl maltol, FD&C YELLOW#6, vanillin, saccharin sodium, sodium metabisulfite), food flavoring; DISTRIBUTED BY RONG SHING TRADING NY INC;
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1510-2025·2025-04-09

    Cordis Smart Control Vascular Stent Size Mismatch Recalled

    Cordis recalled 20 units of its Smart Control Vascular Stent System ILIAC due to a labeling mix-up where the external label does not match the actual stent size. Wrong-sized stents could cause serious vessel complications if implanted.

    Product
    Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1503-2025·2025-04-09

    Laboratory diagnostic reagent distributed with incorrect calibration value on package label

    Fisher Diagnostics is recalling Pacific Hemostasis Thromboplastin-D reagent (1,699 units) due to an incorrect International Sensitivity Index (ISI) value printed on the box. No illnesses or injuries have been reported.

    Product
    Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-0671-2025·2025-04-02

    Dietary Supplement Recalled for Iodine Content Exceeding Label Claims

    Veridance Pharmacal is recalling 450 bottles of Omni-Macs McDonagh Medical Center Dietary Supplement because iodine levels exceed what is claimed on the label. One customer in Gladstone, Missouri received the affected product.

    Product
    Omni-Macs McDonagh Medical Center Dietary Supplement 100 CAPSULES, Suggested Use: 1-3 capsules per day with meals, Distributed by: McDonagh Medical Center Gladstone, MO 64119
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1274-2025·2025-03-12

    Hiossen Dental Abutments Misidentified on Patient Chart Stickers

    Hiossen is recalling patient chart stickers for dental abutments that incorrectly identify product versions. Stickers mislabel ET Rigid Abutments as Regular and ET Multi Abutments as Mini. Dentists should verify actual product versions against packaging labels.

    Product
    Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended for use with a dental implant to provide suport for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETMTA503RV1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1141-2025·2025-02-19

    Spore Test Monitoring System Printing Error May Cause Result Misdirection

    HF Acquisition Co LLC is recalling Bio52 and Bio12 HealthFirst Mail In Monitoring Systems (4,021 units) due to a printing error on return envelopes that may cause spore test results to be reported to incorrect customer accounts.

    Product
    Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-0981-2025·2025-01-29

    Stryker neurosurgical device labeling mismatch: wrong instruments shipped

    Stryker is recalling 3.0MM Neuro Match Head devices (REF 5820-107-430) where the actual device may not match the product label, potentially causing surgeons to use wrong instruments during neurosurgery.

    Product
    stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0978-2025·2025-01-29

    Integra implantable hydrocephalus valve recalled for incorrect product description on labels

    Integra LifeSciences is recalling CODMAN CERTAS Plus Programmable Valves (Model 828810PL) due to incorrect product descriptions on internal and external labels. The mislabeling affects 170 units distributed across the US and several international locations.

    Product
    CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0820-2025·2025-01-15

    Citric acid dialysis concentrate recalled for incorrect case labeling

    Nipro Renal Solutions USA is recalling Citric Complete dry citric acid concentrate due to mislabeled outer cases that show incorrect potassium and calcium content values.

    Product
    Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0805-2025·2025-01-15

    Diagnostic Immunoassay Kits Recalled for Incorrect Expiration Date Labeling

    Qualigen is recalling 426 units of FastPack SHBG diagnostic kits due to incorrect expiration date labels on three lots. The kits were distributed to 15 U.S. states.

    Product
    The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in human serum and plasma. For in vitro diagnostic Use and contains 30 FastPacks.
    Category
    Medical Device
    Distribution
    15 states