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.

7476–7500 of 88183

  • HighFDA (Devices)·Z-2008-2025·2025-07-02

    Altivate Reverse Torx Peripheral Screw labeling mismatch recall

    Encore Medical is recalling Altivate Reverse Torx Peripheral Screws because package labeling indicates a different screw size than the product actually included. This mismatch could lead to incorrect surgical implantation.

    Product
    Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder…
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Food)·H-0077-2025·2025-07-02

    Nature Mills Horsegram Rice Mix recalled for undeclared wheat allergen

    NatureMills US Incorporated is recalling Nature Mills Horsegram Rice Mix (200g) due to undeclared wheat allergens. The product was distributed via the firm's website throughout the USA.

    Product
    Nature Mills Horsegram Rice Mix, 200g
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2002-2025·2025-07-02

    BD Insyte Autoguard Shielded IV Catheter needle retraction defect

    Becton Dickinson is recalling one lot of BD Insyte Autoguard Shielded IV Catheters (REF 381433, 20GA x 1.00 in) due to reports that the catheter needle may retract slowly or fail to retract completely.

    Product
    REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2007-2025·2025-07-02

    BD Insyte Autoguard Shielded IV Catheter needle retraction failure

    Becton Dickinson is recalling BD Insyte Autoguard Shielded IV Catheters (20 GA x 1.16 in, REF 381434) because the catheter needle may be slow to retract or fail to retract entirely.

    Product
    REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0071-2025·2025-07-02

    Idly Chili Powder 200g recalled for undeclared wheat allergen

    NatureMills US Incorporated is recalling Idly Chili Powder 200g because it contains undeclared wheat, a common allergen that poses a risk to consumers with wheat allergies.

    Product
    Idly Chili Powder 200g
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2017-2025·2025-07-02

    BD Pyxis Dispensing Cabinet Software Configuration Error Medical Device Recall

    CareFusion is recalling BD Pyxis automated dispensing cabinets and related devices due to a software configuration issue that can prevent user access to the medication dispensing application. This may delay patient care when Microsoft patches are installed during system upgrades.

    Product
    Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4000 Main 10885403512629 [303], BD Pyxis MedStation ES Tower 10885403512674 [352], BD Pyxis Anesthesia Station ES 10885403477836 [327], BD Pyxis MedStation ES…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2009-2025·2025-07-02

    Altivate Reverse Torx Peripheral Screw labeling mismatch recall

    Encore Medical is recalling Altivate Reverse Torx Peripheral Screws because package labeling lists a different size than the actual product included inside.

    Product
    Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Catalog Number: 506-04-122 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder…
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Drugs)·D-0489-2025·2025-07-02

    Dobutamine Injection Recall Due to Discoloration and Cracked Vials

    Pfizer is recalling one lot of Dobutamine Injection (250 mg/20 mL) nationwide due to discoloration and discolored solution caused by cracked vials. Healthcare facilities should quarantine and return affected units.

    Product
    DOBUTAMINE — DOBUTAMINE (DOBUTAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0093-2025·2025-07-02

    Protrim Plus Dietary Supplement Recall for Undeclared Food Dyes

    Protrim Plus dietary supplement 90-capsule bottles contain undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No. 1) in the gelatin capsules. The product was distributed nationwide and may pose a risk to consumers with dye sensitivities or allergies.

    Product
    Protrim Plus, dietary supplement. 90 capsule/bottles. Legere Pharmaceuticals 15344 N 83rd way, Scottsdale AZ 85260 (Product does not have a UPC)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2026-2025·2025-07-02

    Jewel Precision Reusable Rigid Sterilization Container System Instructions Mismatch

    Jewel Precision Reusable Rigid Sterilization Container System (Model JP-24-6) is being recalled because the Instructions for Use do not match the FDA-cleared indications for use or sterility shelf life.

    Product
    Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0072-2025·2025-07-02

    Nature Mills Sesame Rice Mix recalled for undeclared milk allergen

    NatureMills US Incorporated is recalling Nature Mills Sesame Rice Mix, 200g, due to undeclared milk. The product was distributed in the USA via the firm's website.

    Product
    Nature Mills Sesame Rice Mix, 200g
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·H-0091-2025·2025-07-02

    Prothin Dietary Supplement Recall for Undeclared Food Dyes

    Preventics, Inc. is recalling Prothin dietary supplement packets because they contain undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No. 1) in the gelatin capsules, which may affect consumers with dye sensitivities or allergies.

    Product
    Prothin, dietary supplement. Seven Packets containing 2 tablets and 4 capsules. Legere Pharmaceuticals 15344 N 83rd way, Scottsdale AZ 85260 (Product does not have a UPC)
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1998-2025·2025-07-02

    LUCAS Chest Compression System demonstration units recalled

    Jolife AB is recalling LUCAS 2, 3, and 3.1 chest compression system demonstration units that may have been provided to customers for clinical use instead of demonstration purposes only.

    Product
    LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0483-2025·2025-07-02

    Tirzepatide Injections Pre-filled Syringe Recalled for Sterility Assurance

    Thrive Health Solutions is recalling Tirzepatide Injections 20mg/mL pre-filled syringes due to lack of assurance of sterility. Approximately 826 syringes distributed nationwide are affected.

    Product
    Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0090-2025·2025-07-02

    Nootri Toto food product recalled due to insanitary conditions

    East Africa Boutique, LLC is recalling Nootri Toto (1 kg packages) distributed to seven retailers in Indiana, Kentucky, Missouri, and Ohio due to products being held under insanitary conditions.

    Product
    Nootri Toto, Net Weight 1 kg, packaged in a cardboard box, packed 12 boxes per case
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·H-0059-2025·2025-07-02

    Madeline's Patisserie Raspberry Croissants Recalled for Undeclared Wheat

    Element 112, LLC is recalling Madeline's Patisserie Raspberry Croissants because they contain undeclared wheat, a major allergen. The recall affects approximately 194 cases distributed to four distributors in Michigan and Ohio.

    Product
    1) Madeline's Patisserie 2.5 ounce Raspberry Croissant, Net Wt. 4 lbs. (1,814.37 g), packaged in a food safe polypropylene bag and packed in a food service case; 24 per case 2) Madeline's Patisserie 3.5 ounce Raspberry Croissant, Net Wt. 6 lbs. 10 oz. (3,005.05 g), packaged in…
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·H-0088-2025·2025-07-02

    Carley's Soft Baked Iced Lemon Cookies recalled for misbranded color

    Carley's Inc. is recalling Soft Baked Iced Lemon Cookies because the label incorrectly identifies an artificial yellow color instead of listing it as FD&C Yellow #5 as required.

    Product
    Carley s Soft Baked Iced Lemon Cookies, 5.34oz Plastic Tray, clear film overwrap w/ Label, 12 units per case
    Category
    Food
    Distribution
    15 states
  • ModerateFDA (Food)·H-0089-2025·2025-07-02

    Super Cereal Plus fortified corn soya blend recalled for insanitary conditions

    East Africa Boutique, LLC. is recalling Super Cereal Plus fortified corn soya blend (1.5 kg bags) distributed to retailers in four states because the products were held under insanitary conditions.

    Product
    Super Cereal Plus fortified corn soya blend, Net Weight 1.5 kg, packaged in a plastic foil bag, packed 9 bags per case
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1995-2025·2025-07-02

    Medline Umbilical Tray sterile packaging defect recall

    Medline is recalling umbilical trays due to a possible packaging defect in the outer Tyvec pouch that protects the sterile product. The defect may compromise sterility.

    Product
    Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0092-2025·2025-07-02

    Super ProTHIN Plus Dietary Supplement Recalled for Undeclared Dyes

    Preventics, Inc. dba Legere Pharmaceuticals is recalling Super ProTHIN Plus dietary supplement because gelatin capsules contain undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No. 1) food colorings.

    Product
    Super ProTHIN Plus, dietary supplement. Seven Packets with 2 tablets & 4 Capsules and 1 packet with 14 Nutrilean capsules. Legere Pharmaceuticals 15344 N 83rd way, Scottsdale AZ 85260 (Product does not have a UPC)
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2027-2025·2025-07-02

    Atellica CH Diluent Contaminated with Sodium Hypochlorite

    Siemens Healthcare Diagnostics is recalling Atellica CH Diluent (SMN 11099300, Lot 0000195412) due to contamination with sodium hypochlorite, which may affect laboratory test results.

    Product
    Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2033-2025·2025-07-02

    Jewel Precision Sterilization Container System Recalled for FDA Non-Clearance

    Jewel Precision Reusable Rigid Sterilization Container System, Model JP-24-8, was not cleared by the FDA. The letter to file supporting the size change was insufficient.

    Product
    Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·H-0070-2025·2025-07-02

    Big O' Smokehouse Whitefish Spread recalled for plastic contamination

    Big O' Smokehouse is recalling 4lb and 8oz containers of Whitefish Spread due to white plastic fragments found in the product. The affected spread was distributed to retail stores and distributors in Michigan and Illinois.

    Product
    Big O' Smokehouse 4lb Whitefish Spread Big O' Smokehouse 8oz Whitefish Spread Packaged in plastic containers
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2011-2025·2025-07-02

    Altivate Reverse Torx Peripheral Screw package labeling mismatch

    Encore Medical is recalling Altivate Reverse Torx Peripheral Screws because the package labeling lists a different size than the actual product included inside.

    Product
    Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-130 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder…
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Food)·H-0060-2025·2025-07-02

    Madeline's Patisserie Butter Croissant Buns recalled for undeclared wheat

    Element 112, LLC is recalling Madeline's Patisserie 4.25 Inch Butter Croissant Buns because they contain undeclared wheat, a major food allergen.

    Product
    Madeline's Patisserie 4.25 Inch Butter Croissant Bun, Net Wt. 4 lbs. 6 oz (1,984.47 g), packaged in a food safe polypropylene bag and packed in a food service case; 24 per case
    Category
    Food
    Distribution
    2 states