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.

16951–16975 of 27263

  • HighFDA (Devices)·Z-1626-2023·2023-05-31

    Diagnostic Cartridge Assay May Fail to Detect Chlamydia Trachomatis Correctly

    Binx Health is recalling a single lot of its CT/NG diagnostic cartridges distributed in Pennsylvania. The cartridges may not accurately detect Chlamydia trachomatis, potentially producing false negative or false positive results.

    Product
    binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0895-2023·2023-05-31

    The Traveler's Best sandwiches recalled for undeclared sesame allergen

    GH Foods LLC is recalling The Traveler's Best Ham & Swiss on Pretzel Roll sandwiches due to undeclared sesame seeds. Sesame is a major allergen; consumers with sesame allergies face serious health risks.

    Product
    The Traveler's Best Ham & Swiss on Pretzel Roll Smoked Ham and Swiss Cheese With Lettuce and Dijon Mustard on a Pretzel Roll Ingredients: Pretzel Bun (Enriched Wheat Flour (Wheat Flour, Malted Barley Flour, Niacin, Iron, Thiamin Mononitrate, Riboflavin, Folic Acid), Water, Sugar,
    Category
    Food
    Distribution
    4 states
  • HighFDA (Drugs)·D-0679-2023·2023-05-31

    Cardioplegia Solution Recalled Due to Sterility Assurance Failure

    Central Admixture Pharmacy Services recalls Cardioplegia Solution (325 bags nationwide) after FDA inspection identified loss of sterility assurance. Product is used in cardiac surgery and requires prescription.

    Product
    Cardioplegia Solution, Maintenance 8:1 non-enriched, low potassium, 24 mEq K, packaged in 300 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0215-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0681-2023·2023-05-31

    Cardiac Perfusion Solution Recalled for Sterility Assurance Issues

    Central Admixture Pharmacy Services is recalling Modified del Nido Microplegia syringes after an FDA inspection raised concerns about their sterility. Approximately 690 syringes distributed nationwide may be affected.

    Product
    Modified del Nido Microplegia, packaged in 40 mL per syringe, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0219-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0707-2023·2023-05-31

    Injectable Oxytocin Lactated Ringer's Solution Recalled for Sterility Concerns

    Central Admixture Pharmacy Services is recalling 21,871 bags of injectable oxytocin mixed with Lactated Ringer's solution nationwide due to sterility assurance failures identified during an FDA inspection.

    Product
    oxyTOCIN 30 units added to Lactated Ringer's 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6039-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0719-2023·2023-05-31

    Vancomycin Dextrose Injectable Recalled Due to Sterility Concerns

    Central Admixture Pharmacy Services is recalling 13,772 bags of vancomycin-dextrose injectable distributed nationwide after an FDA inspection questioned its sterility assurance. No illnesses have been reported.

    Product
    vancomycin added to dextrose 5%, 1.25 g/250 mL* (5 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6073-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0725-2023·2023-05-31

    Vancomycin Sodium Chloride Injection Recalled Due to Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling 11,338 bags of vancomycin sodium chloride injection nationwide due to FDA concerns about product sterility following an inspection.

    Product
    vancomycin added to 0.9% sodium chloride, 1.5 g/500 mL* (3 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6176-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0711-2023·2023-05-31

    Oxytocin Injectable Drug Recalled Over Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling 1,332 bags of oxytocin injectable solution due to FDA concerns about sterility assurance. The company could not confirm the product met sterility standards after an FDA inspection.

    Product
    oxyTOCIN 60 units added to 0.9% sodium chloride 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6045-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0752-2023·2023-05-31

    Potassium Acetate Injection Recalled for Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling Potassium Acetate Injection after an FDA inspection raised concerns about sterility assurance. The recall affects 3,326 bags nationwide.

    Product
    Potassium Acetate Injection, 2 mEq/mL, 500 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8078-1, code 7128580781.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1617-2023·2023-05-31

    Omnicell IVX Station medical device recalled for dose accuracy failures

    OmniCell recalls six Omnicell IVX Station devices used for automated pharmaceutical preparation. The devices may not account for scale inaccuracy, potentially allowing incorrect doses to pass quality checks.

    Product
    Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0909-2023·2023-05-31

    Country Cookie Molasses Cookies Recalled for Undeclared Milk Allergen

    Country Cookie LLC is recalling molasses cookies due to undeclared milk allergen on the label. Consumers with milk allergies who consume this product face serious allergic reactions.

    Product
    Country Cookie Molasses cookie, plastic wrapped
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0673-2023·2023-05-31

    Cardioplegia Solution Recall Due to Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling cardioplegia solution due to lack of assurance of sterility. An FDA inspection raised concerns about whether the 329 bags were properly sterilized.

    Product
    Cardioplegia Solution, Modified St Thomas Formula, HIGH POTASSIUM, 122 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0209-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0901-2023·2023-05-31

    Country Cookie Oatmeal Scotchie Cookies Recalled for Undeclared Milk Allergen

    Country Cookie LLC. is recalling Oatmeal Scotchie cookies because milk is present in the product but not declared on the allergen statement. Consumers with milk allergies should not consume these products.

    Product
    Country Cookie Oatmeal Scotchie cookie, plastic wrapped
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0695-2023·2023-05-31

    Neonatal TPN Starter Bags Recalled for Unassured Sterility

    Central Admixture Pharmacy Services is recalling 135 bags of neonatal TPN starter bags distributed nationwide because the FDA found inadequate assurance of sterility during inspection.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 10% with low calcium and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0425-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0654-2023·2023-05-31

    FDA Recalls Cardioplegia Solution Due to Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling Cardioplegia Solution due to lack of sterility assurance. An FDA inspection questioned sterility of 254 bags distributed nationwide.

    Product
    Cardioplegia Solution, Reperfusate 4:1 low potassium/low tromethamine, 15 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0009-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0697-2023·2023-05-31

    Neonatal TPN Bags Recalled Due to Sterility Assurance Concerns

    Central Admixture Pharmacy Services recalled 485 bags of Neonatal TPN Starter Bag nationwide due to FDA concerns about manufacturing sterility assurance. No illnesses have been reported.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10% with low calcium and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0428-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0950-2023·2023-05-31

    TruBoost Drink Citrine Spark Recalled for Prohibited Dietary Ingredients

    TruVision Health LLC is recalling TruBoost Drink - Citrine Spark because it contains DMHA and/or hordenine, which the FDA has determined are not acceptable dietary ingredients. Consumers should not consume the product.

    Product
    TruBoost Drink - Citrine Spark
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0664-2023·2023-05-31

    Cardioplegia Solution Recalled Due to Sterility Assurance Issues

    Central Admixture Pharmacy Services is recalling Cardioplegia Solution (Induction 4:1 High Potassium) due to lack of sterility assurance following an FDA inspection. The recall affects 84 bags distributed nationwide.

    Product
    Cardioplegia Solution, Induction 4:1 High Potassium, 30 mEq K, packaged in 415 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0106-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0936-2023·2023-05-31

    Simple Truth Plant Based Ranch Dressing Mislabeled as Caesar Dressing

    Litehouse Inc. is recalling Simple Truth Plant Based Ranch Dressing 12 oz bottles (UPC 01110609779) because bottles labeled as ranch dressing contain Caesar dressing instead. Affected product has lot code 1713802052623 and was distributed in Indiana.

    Product
    Simple Truth Plant Based Ranch Dressing 12floz bottle UPC 01110609779. 6 retail bottle per wholesale case.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0914-2023·2023-05-31

    Country Cookie Chocolate Brownies Recalled for Undeclared Milk Allergen

    Country Cookie Chocolate Brownies sold in Missouri and Kansas are being recalled because they contain milk but the allergen is not declared on the label.

    Product
    Country Cookie Chocolate Brownie, plastic clamshell
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0754-2023·2023-05-31

    FDA Recalls HyperLyte CR Injection for Lack of Sterility Assurance

    The FDA recalled HyperLyte CR Injection because the manufacturer could not assure the product met sterility requirements. The recall affects 554 bags distributed nationwide.

    Product
    HyperLyte CR Injection, 500 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8094-1, code 7128580941.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1629-2023·2023-05-31

    Arjo Portable Scale Adaptor Model 700.05725 Recalled for Potential Strap Detachment

    Arjohuntleigh Magog, Inc. is recalling certain Arjo Portable Scale Adaptors due to straps with potential to detach. Three units were distributed in Ohio and New York.

    Product
    Arjo Portable Scale Adaptor, Model Number 700.05725; accessory intended to be used in combination with compatible patient lifting equipment
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Drugs)·D-0655-2023·2023-05-31

    Cardioplegia Solution Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling a cardioplegia solution used in cardiac surgery due to lack of assured sterility following an FDA inspection. The product poses a potential infection risk to surgical patients.

    Product
    Cardioplegia Solution, Warm Induction 4:1 HIGH POTASSIUM/low tromethamine, 40 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0011-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0910-2023·2023-05-31

    Country Cookie No Bake cookies recalled for undeclared milk allergen

    Country Cookie LLC is recalling Country Cookie No Bake cookies and Country Cookie Cup of Mini Cookies No Bake sold in MO and KS because the allergen statement fails to declare milk.

    Product
    Country Cookie No Bake cookie, plastic wrapped; Country Cookie Cup of Mini Cookies No Bake
    Category
    Food
    Distribution
    2 states