The Recall Desk

Hazard

Class Ii recalls

1,428 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,428
Critical
0
Severe
0
Most recent
2026-07-08

Of the 1,428 class ii recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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 class ii 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.

1051–1075 of 1428

  • HighFDA (Devices)·Z-2239-2025·2025-08-13

    Pinnacle 3 radiation planning software may miscalculate stopping power ratio

    Pinnacle 3 with TumorLOC Radiation Therapy Planning System software is being recalled because a software issue may provide incorrect dataset calculations when performing the Stopping Power Ratio. 149 serial numbers affected.

    Product
    Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2264-2025·2025-08-13

    UIBC assay does not meet its labeled hemoglobin interference claim

    The Unsaturated Iron Binding Capacity assay is being recalled because it is not meeting the labeled hemoglobin interference claims stated in its instructions for use. 56,696 units affected.

    Product
    UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Food)·H-0386-2025·2025-08-13

    Human donor milk recalled over an inaccurate pasteurization machine thermometer reading

    OH MMB Human Donor Milk is being recalled because of an inaccurate temperature reading from a thermometer on one pasteurization machine. 5,735 units in total are affected.

    Product
    1) OH MMB Human Donor Milk, 20.00 Cal/oz, 1.00 g/dl Protein, packaged in 3 oz plastic bottles 2) OH MMB Human Donor Milk, 20.00 Cal/oz, 0.80 g/dl Protein, packaged in 6 oz plastic bottles Note: The exact concentration of protein varies based on the needs of each individual.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2276-2025·2025-08-13

    Guedel airways may carry small burrs that could detach and be inhaled

    One-piece Guedel airways, size 3, are being recalled because of potential contamination with small burrs which, if they detach, could be inhaled. 8,640 pieces are affected.

    Product
    One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2272-2025·2025-08-13

    epoc BUN test cards may show a negative sodium bias

    epoc BGEM BUN Test Cards are being recalled because a negative sodium bias may exist in some lots, with an observed average bias of -4.4 mmol/L. 37,554 units are affected.

    Product
    epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0553-2025·2025-08-13

    Compounded semaglutide 0.22 mg vials recalled over lack of processing controls

    Semaglutide + Cyanocobalamin 0.22 mg + 0.25 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 290 vials are affected.

    Product
    Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0561-2025·2025-08-13

    Compounded semaglutide 0.44 mg vials recalled over lack of processing controls

    Semaglutide + Cyanocobalamin 0.44 mg + 0.25 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 221 vials are affected.

    Product
    Semaglutide + Cyanocobalamin 0.44 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·H-0383-2025·2025-08-13

    Queen Bee Gardens pure whipped honey may contain stainless steel flakes

    Queen Bee Gardens Whipped Honey Pure in 11 oz jars is being recalled because the product may have small flakes of stainless steel in it. 112 jars are affected.

    Product
    Brand Name: Queen Bee Gardens Whipped Honey Pure. Intended use: spread. Item is shelf stable. Packaging type: Jar. Net wt., 11oz. UPC: 788394182006. Firm Name: Queen Bee Gardens Firm Address: 262 East Main Street, Lovell, WY 82431
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2274-2025·2025-08-13

    DASH COVID and flu tests may give a false negative result

    DASH SARS-CoV-2 & Flu A/B Tests are being recalled because a manufacturing error means the assay may result in a missed diagnosis or delay of treatment through a potential false negative. 710 units affected.

    Product
    DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test. Each DASH SARS-CoV-2 & Flu A/B Test is individually pouched and labeled. The tests are provided to users in quantities of 10 per kit. Used on the DASH instrument.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2277-2025·2025-08-13

    Stryker SmartPump tourniquet cuff flanges may detach from the bladder

    Stryker SmartPump Tourniquet disposable cuffs are being recalled because the cuff flange may become detached from the bladder, which the manufacturer links to a risk of hemorrhage if a leak occurs during a procedure.

    Product
    Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP 18X3,1BLA,2PRT QUICK / 5921-018-235; DISP 24X4,1BLA, 2PRT QUICK / 5921-024-235
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0389-2025·2025-08-13

    Breaded jalapeno mac and cheese bites used a recalled Listeria ingredient

    Breaded Jalapeno Mac & Cheese Bites in 30 lb cases are being recalled because a supplier recalled an ingredient used in the finished product for possible Listeria monocytogenes contamination. 819 cases affected.

    Product
    BREADED JALAPENO MAC & CHEESE BITES Mac & Cheese Bites, Net Wt. 30 LB. 90935, (01)10077886909359, Prepared and Packaged by LOUISA FOOD PRODUCTS, INC. St. Louis, MO 63136; COOKING DIRECTIONS: Deep fry at 350F for 3 1/2 to 4 minutes or until internal temperature reaches 160F.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0565-2025·2025-08-13

    Compounded semaglutide 2.67 mg vials recalled over lack of processing controls

    Semaglutide + Cyanocobalamin 2.67 mg + 0.25 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 158 vials are affected.

    Product
    Semaglutide + Cyanocobalamin 2.67 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0555-2025·2025-08-13

    Compounded tirzepatide 4.4 mg vials recalled over lack of processing controls

    Tirzepatide + Niacinamide 4.4 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 170 vials are affected.

    Product
    Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0566-2025·2025-08-13

    Doxepin hydrochloride capsules exceed the interim nitrosamine impurity limit

    Doxepin Hydrochloride Capsules USP 10 mg from Alembic are being recalled because a nitrosamine drug substance related impurity was present above the proposed interim limit. 9,492 bottles affected.

    Product
    DOXEPIN HYDROCHLORIDE — DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0392-2025·2025-08-13

    Cesarina Mediterranean mix cookies omit sesame from the contains statement

    Cesarina Mediterranean Mix Cookies, 16 oz, are being recalled because sesame is not listed in the Contains statement. 30 cases are affected.

    Product
    MEDITERRANEAN MIX COOKIES, Cesarina Cookies, Net Weight. 16 oz. (454g), packaged in plastic clam shell containers, 12 packages per master case. Dry storage.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-0563-2025·2025-08-13

    Compounded semaglutide 1.5 mg vials recalled over lack of processing controls

    Semaglutide + Cyanocobalamin 1.5 mg + 0.25 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 190 vials are affected.

    Product
    Semaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0557-2025·2025-08-13

    Compounded tirzepatide 8.8 mg vials recalled over lack of processing controls

    Tirzepatide + Niacinamide 8.8 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 139 vials are affected.

    Product
    Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·H-0456-2025·2025-08-13

    Frederik's by Meijer sea salt flatbread crackers contain undeclared sesame

    Frederik's by Meijer Artisan Baked Sea Salt flatbread crackers, 5.5 oz, are being recalled because of undeclared sesame. 1,790 retail units are affected.

    Product
    Frederik's by Meijer Artisan Baked Sea Salt flatbread crackers net wt 5.5oz. UPC 7 13733 00048 2
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-0560-2025·2025-08-13

    Compounded tirzepatide 16.6 mg vials recalled over lack of processing controls

    Tirzepatide + Niacinamide 16.6 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 155 vials are affected.

    Product
    Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 3 x 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0556-2025·2025-08-13

    Compounded tirzepatide 6.6 mg vials recalled over lack of processing controls

    Tirzepatide + Niacinamide 6.6 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 160 vials are affected.

    Product
    Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0554-2025·2025-08-13

    Compounded tirzepatide and niacinamide vials recalled over lack of processing controls

    Tirzepatide + Niacinamide 2.2 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 236 vials are affected.

    Product
    Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0558-2025·2025-08-13

    Compounded tirzepatide 11.24 mg vials recalled over lack of processing controls

    Tirzepatide + Niacinamide 11.24 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 146 vials are affected.

    Product
    Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0574-2025·2025-08-13

    Spironolactone 25 mg tablets recalled after aluminum was found in product

    Spironolactone Tablets USP 25 mg are being recalled because of the presence of a foreign substance identified as aluminum. 11,328 bottles are affected.

    Product
    SPIRONOLACTONE — SPIRONOLACTONE (SPIRONOLACTONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2270-2025·2025-08-13

    DxI 600 immunoassay analyzer motor current resets below the required setting

    A DxI 600 Access Immunoassay Analyzer is being recalled because software overwrites the factory PnP X-motor current setting, causing increased motion errors that could delay patient results.

    Product
    DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0406-2025·2025-08-13

    Milo's extra sweet tea recalled after a shipping trailer temperature excursion

    Milo's Extra Sweet Tea, 1 gallon, is being recalled because of temperature abuse following a temperature excursion in one shipping trailer. 3 units are affected.

    Product
    Milo's Extra Sweet Tea, 128 FL OZ (1 GAL) 3.78 L, packaged in a plastic jug, UPC: 091475931982
    Category
    Food
    Distribution
    1 state