The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

4051–4075 of 52939

  • HighFDA (Food)·H-0284-2025·2025-07-23

    Chocolate crunch cake bars recalled over potential Listeria monocytogenes contamination

    Chocolate Crunch Cake Bar frozen stick novelties are being recalled because of potential Listeria monocytogenes contamination. The action covers 110,292 cases across all affected products.

    Product
    Chocolate Crunch Cake Bar (85000), stick novelties 3 FL. Oz (89mL)., Individually packaged in a plastic bag. Master case that consists of 4 packers with 24 units in each packer, total 96 units in a master case. Keep Frozen.
    Category
    Food
    Distribution
    23 states
  • HighFDA (Devices)·Z-2126-2025·2025-07-23

    EMPOWR 3D knee tibial inserts were packaged with the wrong implant

    EMPOWR 3D Knee Tibial Insert E-PLUS units are being recalled because of a packaging discrepancy in which incorrect tibial inserts were packaged. 20 units are affected.

    Product
    Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number: 341-12-711 Software Version: NA Product Description: Enovis" knee devices are intended for treatment of patients who are candidates for knee arthroplasty p
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Drugs)·D-0532-2025·2025-07-23

    Lisinopril and hydrochlorothiazide bottle contained a foreign antiretroviral tablet

    Lisinopril and Hydrochlorothiazide Tablets 20 mg/12.5 mg are being recalled after a complaint that a sealed bottle contained a foreign tablet identified as atazanavir and ritonavir. 58,968 bottles affected.

    Product
    LISINOPRIL AND HYDROCHLOROTHIAZIDE — LISINOPRIL AND HYDROCHLOROTHIAZIDE (LISINOPRIL AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0302-2025·2025-07-23

    YoCrunch strawberry two-product yogurt packages may contain plastic pieces

    YoCrunch Lowfat Yogurt with Toppers two-product packages containing strawberry yogurt with M&Ms and with Oreo pieces are being recalled because of foreign material in the form of plastic pieces.

    Product
    YoCrunch Lowfat Yogurt with Toppers. Two-product package. Contains 8-6oz (170g) cups of Strawberry Yogurt with milk chocolate M&Ms pieces (cup UPC 46675-00084), and 8-6oz (170g) cups of Strawberry Yogurt with Oreo pieces (cup UPC46675-00083). Two-Pack UPC 46675-02613. Kee
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0524-2025·2025-07-23

    Levothyroxine sodium 175 microgram tablets assayed below the approved specification

    Levothyroxine Sodium Tablets, USP 175 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 2,344 bottles affected.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0290-2025·2025-07-23

    Cotton Candy Twirl bars recalled over potential Listeria monocytogenes contamination

    Cotton Candy Twirl Bar frozen stick novelties are being recalled because of potential Listeria monocytogenes contamination. The action covers 110,292 cases across all affected products.

    Product
    Cotton Candy Twirl Bar (86260), stick novelties 2.5 FL. Oz (74mL)., Individually packaged in a plastic bag. Master case that consists of 4 packers with 24 units in each packer, total 96 units in a master case. Keep Frozen.
    Category
    Food
    Distribution
    23 states
  • HighFDA (Devices)·Z-2112-2025·2025-07-23

    BLS laser show projectors shipped without a working remote interlock connector

    BLS laser light show projectors, models CLUB 1000, 2000 and 4000, are being recalled because the remote interlock connector required by federal regulation was not installed or was not wired. 12 units affected.

    Product
    Laser light show projectors manufactured by BLS, Model CLUB 1000/2000/4000.
    Category
    Other
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2115-2025·2025-07-23

    Access Vitamin B12 reagent lot can give erroneously low or high results

    Access Vitamin B12 Reagent lot 439850 is being recalled after complaints of erroneous results, which may lead to a delayed or improper diagnosis or repeat testing. 10,000 units are affected.

    Product
    Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0518-2025·2025-07-23

    Levothyroxine sodium 25 microgram tablets assayed below the approved specification

    Levothyroxine Sodium Tablets, USP 25 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 82,159 bottles affected.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0523-2025·2025-07-23

    Levothyroxine sodium 150 microgram tablets assayed below the approved specification

    Levothyroxine Sodium Tablets, USP 150 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 4,921 bottles affected.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0289-2025·2025-07-23

    Fudge Frenzy bars recalled over potential Listeria monocytogenes contamination

    Fudge Frenzy Bar frozen stick novelties are being recalled because of potential Listeria monocytogenes contamination. The action covers 110,292 cases across all affected products.

    Product
    Fudge Frenzy Bar (86210), stick novelties 2.5 FL. Oz (74mL)., Individually packaged in a plastic bag. Master case that consists of 4 packers with 24 units in each packer, total 96 units in a master case. Keep Frozen.
    Category
    Food
    Distribution
    23 states
  • HighFDA (Food)·H-0295-2025·2025-07-23

    YoCrunch vanilla yogurt with Oreo pieces may contain plastic material

    YoCrunch Low Fat Yogurt with Toppers, Vanilla with Oreo cookie pieces, is being recalled because of foreign material in the form of plastic.

    Product
    YoCrunch Low Fat Yogurt with toppers. Vanilla with Oreo cookie pieces, Packaged in the following size containers: 1. Single Serve Cup, 6 oz. (170g) UPC 46675-00080 2. Multipack containing 4-4 oz. cups UPC 46675-01350 Keep Refrigerated. Distributed by Danone US, LLC, White
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0286-2025·2025-07-23

    Rich Bar frozen novelties recalled over potential Listeria monocytogenes contamination

    Rich Bar frozen stick novelties are being recalled because of potential Listeria monocytogenes contamination. The action covers 110,292 cases across all affected products.

    Product
    Rich Bar (85155), stick novelties 3 FL. Oz (89mL)., Individually packaged in a plastic bag. Master case that consists of 4 packers with 24 units in each packer, total 96 units in a master case. Keep Frozen.
    Category
    Food
    Distribution
    23 states
  • HighFDA (Food)·H-0292-2025·2025-07-23

    Savagely Sour cherry bars recalled over potential Listeria monocytogenes contamination

    Savagely Sour Cherry Bar frozen stick novelties are being recalled because of potential Listeria monocytogenes contamination. The action covers 110,292 cases across all affected products.

    Product
    Savagely Sour Cherry Bar (86266), stick novelties 2.5 FL. Oz (74mL)., Individually packaged in a plastic bag. Master case that consists of 4 packers with 24 units in each packer, total 96 units in a master case. Keep Frozen.
    Category
    Food
    Distribution
    23 states
  • HighFDA (Food)·H-0291-2025·2025-07-23

    Savagely Sour blue raspberry bars recalled over potential Listeria contamination

    Savagely Sour BlueRasberry Bar frozen stick novelties are being recalled because of potential Listeria monocytogenes contamination. The action covers 110,292 cases across all affected products.

    Product
    Savagely Sour BlueRasberry Bar (86265), stick novelties 2.5 FL. Oz (74mL)., Individually packaged in a plastic bag. Master case that consists of 4 packers with 24 units in each packer, total 96 units in a master case. Keep Frozen.
    Category
    Food
    Distribution
    23 states
  • HighFDA (Food)·H-0288-2025·2025-07-23

    Orange Cream bars recalled over potential Listeria monocytogenes contamination

    Orange Cream Bar frozen stick novelties are being recalled because of potential Listeria monocytogenes contamination. The action covers 110,292 cases across all affected products.

    Product
    Orange Cream Bar (86010), stick novelties 2.5 FL. Oz (74mL)., Individually packaged in a plastic bag. Master case that consists of 4 packers with 24 units in each packer, total 96 units in a master case. Keep Frozen.
    Category
    Food
    Distribution
    23 states
  • HighFDA (Food)·H-0296-2025·2025-07-23

    YoCrunch vanilla yogurt with Snickers pieces may contain plastic pieces

    YoCrunch Low Fat Yogurt with Toppers, Vanilla with Snickers pieces, is being recalled because of foreign material in the form of plastic pieces.

    Product
    YoCrunch Low Fat Yogurt with Toppers, Vanilla with Snickers pieces, Packaged in the following size containers: 1. Single Serve Cup, 6 oz. (170g) UPC 46675-00112 2. Multipack containing 4-4 oz. cups UPC 46675-01326 Keep Refrigerated. Distributed by Danone US, LLC, White Pla
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0300-2025·2025-07-23

    YoCrunch strawberry yogurt with M&M toppers may contain plastic pieces

    YoCrunch Low Fat Yogurt with Toppers, Strawberry with milk chocolate M&Ms minis, is being recalled because of foreign material in the form of plastic pieces.

    Product
    YoCrunch Low Fat Yogurt with Toppers, Strawberry with milk chocolate M&Ms minis candies, Packaged in the following size containers: 1. Single Serve Cup, 6 oz. (170g) UPC 46675-00083 2. Multipack containing 4-4 oz. cups UPC 46675-01312 Keep Refrigerated. Distributed by Dano
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2111-2025·2025-07-23

    BLS DIODE laser projectors shipped without a working remote interlock connector

    BLS laser light show projectors, models DIODE 1000, 2000 and 3000, are being recalled because the remote interlock connector required by federal regulation was not installed or was not wired. 10 units affected.

    Product
    Laser light show projectors manufactured by BLS, Model DIODE 1000/2000/3000.
    Category
    Other
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2119-2025·2025-07-23

    NIO+ intraosseous device stabilizer may not release properly after insertion

    The NIO Intraosseous Device Adult is being recalled because a manufacturing error means the built-in stabilizer may not be released properly after deployment and insertion. 516 US units affected.

    Product
    Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intraosseous access device supplied Sterile and single use. Indicated for Intraosseous access to t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0297-2025·2025-07-23

    YoCrunch vanilla yogurt with Twix pieces may contain plastic pieces

    YoCrunch Low Fat Yogurt with Toppers, Vanilla with Twix bar pieces, is being recalled because of foreign material in the form of plastic pieces.

    Product
    YoCrunch Low Fat Yogurt with Toppers, Vanilla with Twix bar pieces, Packaged in the following size containers: 1. Single Serve Cup, 6 oz. (170g) UPC 46675-00113 2. Multipack containing 4-4 oz. cups UPC 46675-01327 Keep Refrigerated. Distributed by Danone US, LLC, White Plai
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0519-2025·2025-07-23

    Levothyroxine sodium 25 microgram bottles of 1000 assayed below specification

    Levothyroxine Sodium Tablets, USP 25 mcg in 1000-count bottles from Accord Healthcare are being recalled because the product is subpotent. 2,352 bottles are affected.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0525-2025·2025-07-23

    Omeprazole capsule bottle contained a foreign divalproex sodium tablet

    Omeprazole Delayed-release Capsules USP 20 mg are being recalled because a foreign Divalproex Sodium Extended-Release 250 mg tablet was found in a bottle. 1,476 bottles affected.

    Product
    OMEPRAZOLE — OMEPRAZOLE (OMEPRAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·25V482000·2025-07-23

    Hyundai IONIQ 5 battery bus bar may be improperly tightened

    Hyundai is recalling certain 2025 IONIQ 5 vehicles because the high voltage battery may contain an improperly tightened bus bar that can short circuit. Owners are told to park outside until repaired.

    Product
    HYUNDAI — HYUNDAI IONIQ 5
    Category
    Vehicle
    Distribution
    Distributed nationwide