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.

12176–12200 of 27206

  • HighFDA (Drugs)·D-0380-2024·2024-03-20

    TRP Natural Eyes Floaters Relief eye drops recalled due to sterility concerns

    Optikem International is recalling TRP Natural Eyes Floaters Relief eye drops nationwide due to lack of assurance of sterility in manufacturing. Affected bottles have lot numbers F404, F405, or F406.

    Product
    TRP Natural Eyes Floaters Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-098-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0374-2024·2024-03-20

    FDA Recalls Betimol Eye Drops for Sterility and Container Closure Defects

    Thea Pharma is recalling Betimol (timolol) ophthalmic solution nationwide for lack of sterility assurance and compromised container closure. The defects could allow contamination of the eye medication.

    Product
    BETIMOL — BETIMOL (TIMOLOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0388-2024·2024-03-20

    Prescription Telmisartan Recalled for Failed Blend Uniformity Specifications

    Micro Labs Limited is recalling 118,080 bottles of Telmisartan 40mg tablets due to failed blend uniformity specifications. The affected lots (SFBG024, SFBG025) were distributed in Puerto Rico, Tennessee, and Rhode Island.

    Product
    TELMISARTAN — TELMISARTAN (TELMISARTAN)
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0382-2024·2024-03-20

    TRP Natural Eyes Pink Eye Relief Eye Drops Recalled for Sterility Concerns

    TRP Natural Eyes Pink Eye Relief sterile eye drops are being recalled due to lack of assurance of sterility. The recall affects 139,656 bottles distributed nationwide.

    Product
    TRP Natural Eyes Pink Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-013-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1291-2024·2024-03-20

    CLEARLINK Solution Set Adapter recalled for potential drip chamber leaks

    Baxter Healthcare recalls CLEARLINK Non-DEHP Solution Set Luer Lock Adapters due to potential leaks in the drip chamber. The recall affects 26,592 units distributed nationwide.

    Product
    CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0371-2024·2024-03-20

    FDA Recalls Rocuronium Bromide Injections Due to Improper Storage

    McKesson Medical-Surgical is recalling Rocuronium Bromide Injection vials due to storage outside label specifications. Seventy vials were distributed to three healthcare accounts in New Mexico, Arizona, and Utah.

    Product
    ROCURONIUM BROMIDE — ROCURONIUM BROMIDE (ROCURONIUM BROMIDE)
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Devices)·Z-1295-2024·2024-03-20

    CVS Health Wound Dressing Recalled for Failed Sterility Testing

    Medline Industries is recalling CVS Health Waterproof Wound Tracking Dressing (REF CVS690330) due to sterility failure. The non-sterile dressings may introduce infection risk when applied to wounds.

    Product
    CVS Health Waterproof Wound Tracking Dressing, REF CVS690330, immediate package contains 1 sterile dressing, 4 in. x 4 in., 4 dressings per box, 24 boxes per case.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1280-2024·2024-03-20

    Siemens Atellica IM Erythropoietin assay recalled for calibration bias error

    Siemens has recalled the Atellica IM Erythropoietin assay due to a 35% negative bias compared to WHO standards. The assay does not achieve claimed reference intervals and could report inaccurate test results.

    Product
    Atellica IM Erythropoietin (EPO) Assay (100 Test)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1293-2024·2024-03-20

    EasyPoint Needle may detach inside patient during use

    Retractable Technologies is recalling EasyPoint Needles (25G x 5/8", REF: 82091) because the needle cannula may detach from the needle holder inside the patient.

    Product
    EasyPoint Needle, 25G x 5/8", REF: 82091
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1296-2024·2024-03-20

    Hip Prosthesis Stem Labels Lack Clear Guidance on Size and Type

    A hip prosthesis stem was recalled due to ambiguous carton label guidance that could cause incorrect implant selection during surgery. The recall affects 382 units.

    Product
    SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0378-2024·2024-03-20

    TRP Natural Eyes Dryness Relief Eye Drops Recalled for Lack of Sterility Assurance

    Optikem International, Inc. is recalling TRP Natural Eyes Dryness Relief eye drops due to lack of assurance of sterility. The product was distributed nationwide in the USA.

    Product
    TRP Natural Eyes Dryness Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-178-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0384-2024·2024-03-20

    FDA Recalls HylaTears Lubricant Eye Drops for Sterility Assurance Issue

    Optikem International is recalling 46,621 bottles of hyalogic For Dry Eyes, HylaTears Lubricant Eye Drops due to lack of assurance of sterility. The product is distributed nationwide.

    Product
    hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bottle, Manufactured for hyalogic, 610 NW Platte Valley Dr., Riverside, MO 64150
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0383-2024·2024-03-20

    TRP Natural Eyes Red Eye Relief eye drops recalled for sterility concerns

    The FDA is recalling 106,704 bottles of TRP Natural Eyes Red Eye Relief eye drops due to lack of sterility assurance. Consumers should stop using the product and contact a healthcare provider if they experience eye irritation or infection.

    Product
    TRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-158-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1066-2024·2024-03-20

    KALO Carrot Cake mislabeled with Chocolate Cake ingredients, soy allergen undisclosed

    KALO Carrot Cake All Natural Gluten Free is mislabeled with Chocolate Cake ingredient information that omits soy, creating an allergen hazard for consumers with soy allergy.

    Product
    KALO Carrot Cake All Natural Gluten Free Serving size one slice (6 oz/177g) CONTAINS MILK, EGG UPC 8 53407 00418 4 Distributed by: Kalo Foods, LLC Stokesdale, NC 27357
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1297-2024·2024-03-20

    Hip prosthesis labeling guidance issue affects 34 units

    The FDA is advising on label interpretation for the SPII Model Lubinus hip prosthesis stem to prevent confusion during surgery. Two complaints prompted additional guidance on carton label size and type columns.

    Product
    SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1279-2024·2024-03-20

    D-Clip Surgical Applier Recalled for Failure to Release During Surgery

    FDA has recalled the D-Clip Standard/Mini Applier due to reports that the device failed to release the clip and remained attached during surgical use, creating a risk of surgical complications.

    Product
    D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1283-2024·2024-03-20

    Ivenix Infusion System Software Defect May Delay or Cause Incorrect Infusions

    Fresenius Kabi recalls Ivenix Infusion System software versions 5.2.1 and 5.2.2 due to two defects that may delay therapy or cause over-infusion. The software fix was deployed to affected units between May and August 2023.

    Product
    LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1060-2024·2024-03-20

    Jacksons Chicken Salad On A Croissant recalled for potential sesame cross contact

    Capitol Commissary LLC is recalling Jacksons Chicken Salad On A Croissant due to potential sesame cross contact. The product was distributed in seven western states.

    Product
    Jacksons Chicken Salad On A Croissant, net wt. 6.7oz. Product is closed-face sandwich on a croissant and ready to eat product. UPC 983642541561.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1281-2024·2024-03-20

    ADVIA Centaur Erythropoietin Assay Affected by -35% Measurement Bias

    Siemens Healthcare's ADVIA Centaur EPO Assay (lots 53984040, 55443042) produces readings 35% lower than the WHO standard, failing to achieve its claimed reference interval. No illnesses reported, but diagnostic inaccuracy poses risk of wrong clinical decisions.

    Product
    ADVIA Centaur Erythropoietin (EPO) Assay (100 Test)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1062-2024·2024-03-20

    Vitony Bakery Cheese-Guava Cake Recalled for Undeclared Yellow Dye Allergens

    Vitony Bakery is recalling Bizcocho de Queso y Guayaba cheese-guava cake for undeclared FD&C Yellow #5 and Yellow #6 dyes. About 6,706 units were distributed in Puerto Rico.

    Product
    Vitony Bakery, Bizcocho de Queso y Guayaba (cheese-guava cake), PESO NETO 14oz (397g) (12 (14 oz) packages per case)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1292-2024·2024-03-20

    Shimadzu Trinias Digital Angiography System Recalled for Capacitor Defect

    Shimadzu has recalled the Trinias Digital Angiography System due to a capacitor manufacturing issue that could cause abnormal display or system malfunction. No injuries have been reported.

    Product
    Shimadzu, Trinias, Digital Angiography System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0379-2024·2024-03-20

    TRP Eye Strain Relief Eye Drops Recalled Due to Lack of Sterility Assurance

    Optikem International recalls TRP Eye Strain Relief eye drops nationwide due to lack of assurance of sterility. Affected units are 10 mL bottles with Lot E206.

    Product
    TRP Eye strain Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-172-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0381-2024·2024-03-20

    TRP Natural Eyes eye drops recalled due to lack of sterility assurance

    TRP Natural Eyes Aging Eye Relief eye drops are being recalled because the manufacturer cannot assure the product meets sterility requirements. The recall affects 19,344 bottles distributed nationwide.

    Product
    TRP Natural Eyes Aging Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-027-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0372-2024·2024-03-20

    Infuvite Adult Multiple Vitamins Injection Recalled for Storage Deviation

    Baxter Healthcare's Infuvite Adult Multiple Vitamins Injection is being recalled because 70 vials were stored outside their labeled specifications, potentially affecting product stability. The affected vials were distributed to three direct accounts in Arizona, New Mexico, and Utah.

    Product
    Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MFG: Baxter Healthcare Corp., NDC 54643-5649-01
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Drugs)·D-0370-2024·2024-03-20

    Potassium Chloride Injection Recalled Due to Pinhole Container Defects

    B. Braun Medical is recalling 22,752 bags of Potassium Chloride for Injection Concentrate nationwide due to pinholes in container bags that compromise sterility assurance. Affected lots are J2S007 (expires 12/31/2024) and J3A115 (expires 01/31/2025).

    Product
    POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide