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.

17026–17050 of 27263

  • HighFDA (Drugs)·D-0675-2023·2023-05-31

    FDA Recalls Cardioplegia Solution Due to Sterility Concerns

    Central Admixture Pharmacy Services is recalling 226 bags of Cardioplegia Solution due to lack of assurance of sterility following FDA inspection. No illnesses reported.

    Product
    Cardioplegia Solution, Maintenance 4:1 Plasmalyte, low potassium, low K, packaged in 1047 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0211-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0726-2023·2023-05-31

    FDA Recalls Heparin-Sodium Chloride Injection Nationwide for Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling 3,055 bags of heparin injection nationwide due to sterility assurance concerns identified during FDA inspection. Healthcare providers and patients should discontinue use of affected lots.

    Product
    heparin added to 0.9% sodium chloride, 7,500 units/1,000 mL* (7.5 units/mL), 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7009-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0740-2023·2023-05-31

    FDA recalls oxytocin admixture bags for lack of sterility assurance

    Central Admixture Pharmacy Services is recalling 2,186 bags of oxytocin intravenous admixture nationwide due to lack of sterility assurance following an FDA inspection.

    Product
    oxyTOCIN 40 units added to 0.9% sodium chloride 1,000 bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8069-1.
    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 (Drugs)·D-0702-2023·2023-05-31

    OxyTOCIN-dextrose injectable recalled nationwide for sterility assurance concerns

    Central Admixture Pharmacy Services is recalling oxyTOCIN 20 units in dextrose 5%/Lactated Ringer's solution nationwide due to lack of sterility assurance identified during FDA inspection. 7,595 bags across multiple lot numbers are affected.

    Product
    oxyTOCIN 20 units added to dextrose 5%/Lactated Ringer's 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6031-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0698-2023·2023-05-31

    FDA Recalls Neonatal Parenteral Nutrition Bags for Sterility Concerns

    Central Admixture Pharmacy Services recalled 328 neonatal parenteral nutrition bags nationwide due to FDA concerns about product sterility after an inspection.

    Product
    Neonatal PN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with low calcium and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100 Allentown, PA 18106, NDC 71285-0429-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0908-2023·2023-05-31

    Country Cookie M&M Cookies Recalled for Undeclared Milk Allergen

    Country Cookie LLC is recalling M&M cookies and mini cups distributed in Missouri and Kansas because the label does not declare milk as an allergen. Consumers allergic to milk should discard the recalled products.

    Product
    Country Cookie M&M cookie, plastic wrapped; Country Cookie Mini Cups of Cookies M&M Cookie
    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-0708-2023·2023-05-31

    FDA Recalls Oxytocin Injection Bags Over Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling 3,865 bags of oxytocin injection across the USA due to lack of sterility assurance identified during an FDA inspection. Sterile injectables must meet strict standards to prevent infection risk.

    Product
    oxyTOCIN 15 units 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 72185-6042-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0755-2023·2023-05-31

    Injectable Drug Recalled for Unverified Sterility After FDA Inspection

    Central Admixture Pharmacy Services is recalling 1673 bags of HyperLyte CR Injection due to lack of sterility assurance. An FDA inspection raised questions about whether the product met sterility standards.

    Product
    HyperLyte CR Injection, 250 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8094-2, code 7128580942.
    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 (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-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-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-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 (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-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-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-0671-2023·2023-05-31

    Cardioplegia Solution Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services recalls Cardioplegia Solution (Maintenance 4:1 in Ringer's) due to lack of sterility assurance confirmed by FDA inspection. The product is used during cardiac surgery and distributed nationwide.

    Product
    Cardioplegia Solution, Maintenance 4:1 in Ringer's, low potassium, 12 mEq K, packaged in 504.8 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0205-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0767-2023·2023-05-31

    Fentanyl Buccal Tablets Recalled for Missing or Incorrect Package Insert

    Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets (200mcg) due to missing or incorrect package inserts. Patients should contact their healthcare provider if they have affected product.

    Product
    Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-635-28
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0943-2023·2023-05-31

    Dietary supplement recalled for containing unapproved ingredients

    TruVision Health LLC is recalling truControl W/Dynamine because the product contains DMHA and/or hordenine, which FDA has determined are not acceptable dietary ingredients.

    Product
    truControl W/Dynamine 60 ct
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1616-2023·2023-05-31

    Olympus Fine Needle Aspiration Needles Recalled for Angle Non-Conformance

    Olympus is recalling 1,297 boxes of fine needle aspiration needles due to a manufacturing defect where the needle angle does not meet specifications, resulting in slight resistance during needle advancement and retraction.

    Product
    To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract Models: NA-U401SX-4022, NA-U401SX-4022-A
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1480-2023·2023-05-31

    Fluoroscopic Imaging System May Display Incorrect Radiation Dose Measurements

    Siemens Luminos dRF Max fluoroscopic imaging systems may occasionally display incorrect radiation dose measurements during certain operating conditions. The manufacturer states the error does not affect diagnosis or workflow.

    Product
    Luminos dRF Max (VE10, VF10, VF11)
    Category
    Medical Device
    Distribution
    Distributed nationwide