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.

17001–17025 of 27263

  • 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 (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-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-0693-2023·2023-05-31

    FDA Recalls Neonatal TPN Starter Bags for Sterility Concerns

    Central Admixture Pharmacy Services recalls 747 bags of Neonatal TPN Starter Bags due to FDA sterility concerns. Products were distributed nationwide across the USA.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4%/Dextrose 10% with 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 71285-0422-1.
    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 (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 (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 (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 (Food)·F-0951-2023·2023-05-31

    TruBoost Drink Ruby Rev recalled for unapproved dietary ingredients

    TruVision Health LLC is recalling TruBoost Drink - Ruby Rev because it contains DMHA and/or hordenine, which the FDA has determined are not acceptable dietary ingredients.

    Product
    TruBoost Drink - Ruby Rev
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0938-2023·2023-05-31

    Julie's Real JR Bar Granola Bars Recalled for Possible Metal Contamination

    Julie's Real JR Bar Cinnamon Vanilla Bean Grain-Free Granola Bars are being recalled due to possible presence of metal. The recall affects approximately 22,290 boxes distributed nationwide.

    Product
    Julie's Real JR Bar Cinnamon Vanilla Bean Grain-Free Granola Bar, Net Wt 1.4 oz (40g), UPC 857628006699, packaged and sold in a 6 Pack Box to consumers, sold as a Master Case of 6, 6 Pack Boxes to retailer and distributor
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0716-2023·2023-05-31

    IV Potassium Phosphate Solution Recalled Due to Sterility Concerns

    Central Admixture Pharmacy Services recalls 9,432 bags of potassium phosphate injectable solution nationwide following FDA inspection findings that questioned the sterility of these pharmaceutical products.

    Product
    potassium phosphate 15 mmole added to 0.9% sodium chloride 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6060-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0953-2023·2023-05-31

    Ceramic Copitas Recalled Due to Potential Lead Leaching

    Pernod Ricard Usa Inc is recalling ceramic copitas (small cups) distributed by Del Maguey because they may exceed FDA guidance levels for leachable lead. The recall affects 177,000 units distributed nationwide since October 2022.

    Product
    Copitas; small ceramic cups; "Del Maguey" embossed on the bottom; distributed by Del Maguey
    Category
    Consumer Product
    Distribution
    1 state
  • 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-0696-2023·2023-05-31

    Neonatal TPN Bags Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 259 neonatal TPN bags nationwide due to lack of assurance of sterility following FDA inspection.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 5% 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 71285-0427-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0720-2023·2023-05-31

    Injectable Vancomycin Admixture Recalled Due to Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling 27,780 bags of vancomycin injectable solution nationwide after an FDA inspection raised concerns about the product's sterility assurance.

    Product
    vancomycin added to 0.9% sodium chloride, 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 71285-6074-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0771-2023·2023-05-31

    Compounded Tirzepatide Injections Recalled Nationwide Due to Sub-Potency

    Revive Rx is recalling 45 vials of compounded tirzepatide 10 mg/0.5 mL injections nationwide due to sub-potency. Patients should contact their healthcare provider about their medication.

    Product
    Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial, Rx Only, For Sub-Q Use Only, Compounded Drug Product By: Revive Rx, 3831 Golf Dr A, Houston, TX 77018, NDC: 99000-9278-64.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1622-2023·2023-05-31

    Philips CT Scanner May Display Images With Incorrect Orientation

    Philips Incisive CT X-ray systems may display medical images in incorrect orientation, potentially leading to misdiagnosis, incorrect treatment, and unnecessary radiation exposure if rescans are needed.

    Product
    Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-0926-2023·2023-05-31

    Blue Crab Dip Recalled for Undeclared Milk Allergen

    Washington Crab & Seafood Company is recalling Blue Crab Dip due to undeclared milk content. Consumers with milk allergies who consume this product may experience allergic reactions.

    Product
    BLUE CRAB DIP 8 oz Ingredients: Blue Crabmeat, cream cheese, vidalia onion, salt, paprika, and spice WASHINGTON CRAB Carolina Seafood
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0897-2023·2023-05-31

    Backpacker's Pantry Blueberry Peach Crisp recalled for undeclared almond allergen

    American Outdoor Products is recalling Backpacker's Pantry Blueberry Peach Crisp pouches because the packaging lacks almond allergen disclosure, though almonds are present in the product.

    Product
    Backpacker s Pantry Blueberry Peach Crisp, 4.6-ounce, packaged in a pouch, UPC-048143026143
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0683-2023·2023-05-31

    Neonatal TPN Starter Bag Recalled for Sterility Assurance Issues

    Central Admixture Pharmacy Services recalls 558 bags of Neonatal TPN Starter Bag nationwide due to lack of sterility assurance identified during an FDA inspection.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10% with CALCIUM, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0405-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0747-2023·2023-05-31

    Injectable Vasopressin Products Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services recalled 1,858 bags of injectable vasopressin nationwide due to FDA concerns about sterility assurance. An FDA inspection questioned whether the products meet required sterility standards.

    Product
    vasopressin 20 units added to 0.9% sodium chloride 100 mL*, 0.2 units/mL*, 100 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-9000-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1631-2023·2023-05-31

    Medical Device Calibrator Recall for Salicylate Assay Due to Measurement Bias

    Siemens Healthcare is recalling ADVIA Chemistry ToxAmmonia Calibrators due to positive bias in salicylate assay measurements. Affected calibrators were distributed across the US and internationally.

    Product
    ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2), ammonia (AMM), acetaminophen (ACET), and salicylate (SAL) assays on the ADVIA¿ Chemistry systems Siemens Material Number (SMN): 10309217
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0911-2023·2023-05-31

    Country Cookie Peanut Butter Cookies Recalled for Undeclared Milk Allergen

    Country Cookie LLC is recalling peanut butter cookies sold in Missouri and Kansas because the allergen label does not declare milk, posing a risk to consumers with milk allergies.

    Product
    Country Cookie Peanut Butter Cookie, plastic wrapped
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0672-2023·2023-05-31

    Cardioplegia Solution Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling its Cardioplegia Solution after an FDA inspection raised concerns about product sterility. The recall affects 333 bags distributed nationwide.

    Product
    Cardioplegia Solution, Induction 4:1 in Ringer's, HIGH POTASSIUM, 48 mEq K, packaged in 522.8 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0206-1.
    Category
    Drug
    Distribution
    Distributed nationwide