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.

6701–6725 of 88183

  • HighFDA (Food)·H-0489-2025·2025-08-20

    Wheat hamburger buns recalled for undeclared milk and eggs from sub-ingredients

    Wheat Hamburger Buns from The Bonami Baking Co., sold in California, are recalled for undeclared milk and/or eggs. The recall covers 61,862 packages.

    Product
    Wheat Hamburger Buns --- Ingredient Declaration: Water, Whole Wheat Flour, Enriched Wheat Flour (Unbleached Wheat Flour, Malted Barley Flour, Niacin, Iron, Thiamin Mononitrate (Vitamin B1) Riboflavin (Vitamin B2), Folic Acid) Eggs, Butter (Pasteurized Cream, Natural Flavorings)…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0577-2025·2025-08-20

    Carvedilol 3.125 mg tablets recalled for nitrosamine impurity above intake limit

    Glenmark Carvedilol Tablets USP, 3.125 mg, in 100- and 500-count bottles are recalled nationwide because N-Nitroso Carvedilol I impurity exceeded the current Acceptable Intake level. 44,328 bottles are affected.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0459-2025·2025-08-20

    La Michoacana strawberry paletas list cream without declaring milk as source

    La Michoacana Strawberry Con Crema Single Serve Paletas are being recalled because the label includes the ingredient cream but does not include milk as the source. 62,864 units affected.

    Product
    La Michoacana Strawberry Con Crema Single Serve Paleta 3.75oz UPC: 7-67778-00002-0
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2282-2025·2025-08-20

    Surgical gauze rolls recalled over biological foreign matter and miscounted packs

    Carefree Surgical Specialties Robotic/Laparoscopy Kittner Rolls Gauze, catalog 15505/25 lot 1645, is recalled for biological foreign matter that could compromise sterility and for incorrect gauze counts. 500 units are affected.

    Product
    Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS Model/Catalog Number: 15505/25 Product Description: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2313-2025·2025-08-20

    SIGNA Premier XT patient table caster lock checks may have been missed

    GE SIGNA Premier XT MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. 2 units affected.

    Product
    GE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2289-2025·2025-08-20

    Plastic trial heads carry inconsistent size terminology and color coding

    Plastic Trial Head Brown with 7 mm neck length is being recalled because of inconsistent size terminology and colour coding used on the labeling. 17 units are affected.

    Product
    Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2317-2025·2025-08-20

    SIGNA Hero Elite patient table caster lock checks may have been missed

    GE SIGNA Hero Elite MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

    Product
    GE SIGNA Hero Elite (China Only), Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·H-0445-2025·2025-08-20

    Lithium orotate 10 mg product recalled for failing labeled potency standard

    Lithium Orotate 10 mg distributed by Enjoy Nutrition, LLC is recalled nationwide because it does not meet its labeled potency, following a recall by the ingredient supplier.

    Product
    Lithium Orotate, 10MG, Distributed by Enjoy Nutrition, LLC. UPC#: 702730894033, 702730894057
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2315-2025·2025-08-20

    SIGNA Premier MAX patient table caster lock checks may have been missed

    GE SIGNA Premier MAX MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

    Product
    GE SIGNA Premier MAX (China Only), Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0583-2025·2025-08-20

    Theophylline extended-release tablets failed dissolution at long-term stability testing

    Theophylline extended-release tablets 400 mg from Glenmark are being recalled because dissolution results at the long-term shelf life stability interval did not comply with L3 stage criteria. 22,656 bottles affected.

    Product
    THEOPHYLLINE — THEOPHYLLINE (THEOPHYLLINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2318-2025·2025-08-20

    SIGNA Hero MAX patient table caster lock checks may have been missed

    GE SIGNA Hero MAX MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

    Product
    GE SIGNA Hero MAX (China Only), Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·H-0448-2025·2025-08-20

    Weyland lithium orotate capsules recalled after an out of specification ingredient

    Weyland Brain Nutrition Lithium Orotate capsules are being recalled as a downstream recall of a dietary supplement ingredient that was manufactured out of specification. About 185,482 capsules affected.

    Product
    Lithium Orotate, Weyland Brain Nutrition ; 60 vegetarian capsules, Dietary Supplement; Distributed by Enjoy Nutirtion, LLC. San Francisco, CA 94108, (415) 894-0537 2.5 mg UPC#: X001SBI13J 5 mg UPC#: X000PY16Z5 10 mg UPC#: X000T9B9B7 20 mg UPC#: X001VBLW8H 1000 MCG UPC#…
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0584-2025·2025-08-20

    Belsomra 10 mg tablets failed dissolution, which may delay sleep onset

    Belsomra (suvorexant) 10 mg tablets are being recalled because of failed dissolution specifications, with potential for delayed release of the drug and delayed onset of sleep. 51,320 cartons affected.

    Product
    BELSOMRA — BELSOMRA (SUVOREXANT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2305-2025·2025-08-20

    SIGNA UHP patient table caster lock checks may have been missed

    GE SIGNA UHP MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. 3 units affected.

    Product
    GE SIGNA UHP, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2292-2025·2025-08-20

    Bartels Legionella urinary antigen kits may contain particulate matter

    Bartels ELISA Legionella Urinary Antigen kits are being recalled because two lots have the potential to contain particulate matter. 968 kits are affected.

    Product
    Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2309-2025·2025-08-20

    SIGNA PET/MR imager recalled over unconfirmed patient table caster lock checks

    GE HealthCare is recalling 97 SIGNA PET/MR imagers because the planned maintenance step that checks the patient table caster locks may not have been performed.

    Product
    GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2288-2025·2025-08-20

    Prosthesis heads carry inconsistent size terminology and color coding on labeling

    Prosthesis Head B, 28 mm with 7 mm neck length, is being recalled because of inconsistent size terminology and colour coding used on the labeling. 46 units are affected.

    Product
    Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2324-2025·2025-08-20

    Anorectal manometry kit outer label shows the manufacturing date as expiry

    Zvu Anorectal Manometry Procedure Kits are being recalled because the outer kit label carries an incorrect expiration date, with the manufacturing date used in its place. 8 kits are affected.

    Product
    Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2312-2025·2025-08-20

    SIGNA Architect AIR MRI recalled over unverified patient table caster lock maintenance

    GE HealthCare is recalling 151 SIGNA Architect AIR (China Only) MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.

    Product
    GE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2301-2025·2025-08-20

    Discovery MR450 1.5T scanners recalled over patient table caster lock maintenance

    GE HealthCare is recalling 19 Discovery MR450 1.5T MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.

    Product
    GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2320-2025·2025-08-20

    SIGNA PET/MR AIR Plus recalled over unperformed patient table caster lock maintenance

    GE HealthCare is recalling SIGNA PET/MR AIR Plus (China Only) systems because the planned maintenance step that checks the patient table caster locks may not have been performed.

    Product
    GE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·H-0444-2025·2025-08-20

    Lithium orotate 5 mg product recalled after failing to meet labeled potency

    Lithium Orotate 5 mg distributed by Enjoy Nutrition, LLC is recalled nationwide for failing to meet its labeled potency, following a recall by the ingredient supplier.

    Product
    Lithium Orotate, 5MG, Distributed by Enjoy Nutrition, LLC. UPC#: 702730893968, 702730894064
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0446-2025·2025-08-20

    Lithium orotate 20 mg product recalled after failing labeled potency testing

    Lithium Orotate 20 mg distributed by Enjoy Nutrition, LLC is recalled nationwide because it does not meet its labeled potency, following a recall by the ingredient supplier.

    Product
    Lithium Orotate, 20MG, Distributed by Enjoy Nutrition, LLC. UPC#: none
    Category
    Food
    Distribution
    Distributed nationwide