The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

6776–6800 of 88183

  • 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 (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-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-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 (Food)·H-0384-2025·2025-08-13

    Queen Bee Gardens whipped honey may contain stainless steel flakes

    Queen Bee Gardens Whipped Honey Huckleberry in 11 oz jars is being recalled because the product may have small flakes of stainless steel in it. 24 jars are affected.

    Product
    Brand Name: Queen Bee Gardens Whipped Honey Huckleberry Intended use: spread. Item is shelf stable. Packaging type: Jar. Net wt., 11oz. UPC: 788394182259. Firm Name: Queen Bee Gardens Firm Address: 262 East Main Street, Lovell, WY 82431
    Category
    Food
    Distribution
    Distributed nationwide
  • 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 (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 (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 (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 (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-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 (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 (Drugs)·D-0552-2025·2025-08-13

    Duloxetine 60 mg capsules exceed the safety assessment limit for nitrosamine

    Duloxetine Delayed-Release Capsules USP 60 mg distributed by Breckenridge are being recalled because N-nitroso-duloxetine was present above the safety assessment limit. 1,829 bottles affected.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-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 (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-0559-2025·2025-08-13

    Compounded tirzepatide 13.2 mg vials recalled over lack of processing controls

    Tirzepatide + Niacinamide 13.2 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 143 vials are affected.

    Product
    Tirzepatide + Niacinamide 13.2 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 (Devices)·Z-2275-2025·2025-08-13

    Size 2 Guedel airways may carry small burrs that could detach

    One-piece Guedel airways, size 2, are being recalled because of potential contamination with small burrs which, if they detach, could be inhaled. 2,800 pieces are affected.

    Product
    One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.
    Category
    Medical Device
    Distribution
    10 states
  • 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
  • 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-0567-2025·2025-08-13

    Duloxetine delayed-release capsules exceed the interim nitrosamine impurity limit

    Duloxetine Delayed-Release 20 mg capsules packaged by Direct Rx are being recalled because a nitrosamine drug substance related impurity was present above the proposed interim limit. 16 bottles affected.

    Product
    Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037, NDC 61919-422-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0385-2025·2025-08-13

    Favorite Day frosted sugar cookies may contain wood foreign material

    Favorite Day Bakery Frosted Sugar Cookies, 10 count, are being recalled because of foreign material, specifically wood. 803 cases are affected.

    Product
    Favorite Day Bakery Frosted Sugar Cookies, 10 count, Net Wt 13.5 oz (383g). UPC - 85239-41250 3. Dist. By Target Corporation, Minneapolis, MN 55403. Product of Canada.
    Category
    Food
    Distribution
    21 states
  • ModerateFDA (Food)·H-0417-2025·2025-08-13

    Yoplait Harvest Peach yogurt recalled after a shipping trailer temperature excursion

    Yoplait Original Harvest Peach Yogurt, 6 oz, is being recalled because of temperature abuse following a temperature excursion in one shipping trailer. 1 unit is affected.

    Product
    Yoplait Original Harvest Peach Yogurt, 6 OZ (170g), packaged in a plastic cup, UPC: 170470003075
    Category
    Food
    Distribution
    1 state