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.

13851–13875 of 88183

  • HighFDA (Drugs)·D-0420-2024·2024-04-03

    PHENYLephrine HCl Injectable Recalled Due to Lack of Sterility Assurance

    SCA Pharmaceuticals is recalling PHENYLephrine HCl 800 mcg/10 mL injections due to lack of assurance of sterility. The recall affects 3,671 syringes distributed nationwide.

    Product
    PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12, Bar Code 700040081612.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1372-2024·2024-04-03

    Laboratory performance verifier recalled for mismatched diluent assembly

    Ortho-Clinical Diagnostics is recalling 10,911 units of VITROS Performance Verifier I worldwide due to mismatched diluent components that could cause inaccurate quality control test results.

    Product
    VITROS Performance Verifier I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1103-2024·2024-04-03

    German Home Bakery Apple Coffee Cake Recalled for Undeclared Wheat and Yellow #5

    German Home Bakery Apple Coffee Cake is being recalled due to undeclared wheat and Yellow #5 food coloring. Consumers with wheat allergies or Yellow #5 sensitivity should not consume this product.

    Product
    German Home Bakery Apple Coffee Cake, 16 oz, clear poly bag
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0407-2024·2024-04-03

    Hydromorphone Injection Recalled Due to Lack of Sterility Assurance

    SCA Pharmaceuticals recalls 1,023 syringes of Hydromorphone Injection nationwide due to lack of sterility assurance. No illnesses have been reported.

    Product
    HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-22, Bar Code 70004030022
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1368-2024·2024-04-03

    Endoscopic Lens Cleaner Recalled for Instruction Discrepancy Risk

    Olympus recalls InstaClear Lens Cleaner devices due to inconsistencies between Japanese and English instruction manuals that could cause component separation during endoscopic procedures.

    Product
    InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Model Number: LCS1500UNOL LCS1800UNST LCS4K00UNOL LCS1530BTOL LCS1830BTST LCS4K30BTOL LCS1530TPOL LCS1830TPST LCS4K30TPOL LCS1545BTOL LCS1845BTST…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0424-2024·2024-04-03

    Succinylcholine Chloride Injection Recalled for Sterility Assurance Failure

    SCA Pharmaceuticals is recalling 5,079 syringes of Succinylcholine Chloride Injection nationwide due to lack of sterility assurance. Affected lots are #1223049085 and #1223049364.

    Product
    SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL fill 6 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0908-09, Bar Code 70004090809
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1364-2024·2024-04-03

    Thermalon Heating Pads Recalled for Potential Mold and Mildew Growth

    Bruder Healthcare recalls Thermalon Heating Pad model 24002 due to potential mold and mildew growth from moisture exposure. Affected units were distributed nationwide in the US and to Canada.

    Product
    Thermalon Heating Pad, Item Number 24002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1105-2024·2024-04-03

    Coffee cake recalled for undeclared Yellow #5 food dye

    Sunflour Bakery is recalling German Home Bakery Raspberry Coffee Cake due to undeclared Yellow #5 dye. The voluntary Class II recall affects 70 loaves distributed in California.

    Product
    German Home Bakery Raspberry Coffee Cake, 16 oz, clear poly bag
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1386-2024·2024-04-03

    Philips Patient Information Center Custom Ringtones Fail When Screen Locked

    Philips Patient Information Center iX running software version 4.X may not play custom ringtones when iOS screens are locked with a passcode. Approximately 257,183 units have been distributed worldwide. No injuries have been reported.

    Product
    Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version Number 4.X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1363-2024·2024-04-03

    Thermalon Neck Wrap recalled due to potential mold and mildew growth

    Bruder Healthcare Company is recalling Thermalon Neck Wrap (Item Number 24322) from certain lots due to potential mold and mildew growth from excessive moisture exposure. Consumers should discontinue use and contact the manufacturer.

    Product
    Thermalon Neck Wrap, Item Number 24322
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1387-2024·2024-04-03

    CareEvent Event Management System notification failure on locked iOS devices

    The CareEvent Event Management System's Care Assist mobile application fails to play custom ringtones when iOS device screens are locked with a passcode. This may result in missed alerts or notifications.

    Product
    CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1104-2024·2024-04-03

    FDA Recalls German Home Bakery Cherry Coffee Cake for Undeclared Yellow #5

    NRS Enterprises, Inc. is recalling German Home Bakery Cherry Coffee Cake due to undeclared Yellow #5. The product was distributed in California and may affect consumers with tartrazine sensitivity.

    Product
    German Home Bakery Cherry Coffee Cake, 16 oz, clear poly bag
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0427-2024·2024-04-03

    FDA Recalls VCF Contraceptive Film Due to Manufacturing Process Violations

    The FDA is recalling VCF Contraceptive Film due to manufacturing process deviations. Apothecus Pharmaceutical Corp. initiated the voluntary recall on March 21, 2024, affecting 17,280 cartons distributed nationwide.

    Product
    VCF CONTRACEPTIVE — VCF CONTRACEPTIVE (NONOXYNOL-9)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1097-2024·2024-04-03

    Bluebonnet Methylfolate Chewables Recalled for Label Unit Error

    Bluebonnet Nutrition is recalling EarthSweet Chewables CellularActive Methylfolate 1000 mcg due to a labeling error stating '1000 mg' instead of '1000 mcg' on the front label.

    Product
    EarthSweet¿ Chewables CellularActive¿ Methylfolate 1000 mcg; 90 chewable tablets packaged in an amber glass botte with purple lid
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-1102-2024·2024-04-03

    Sunflour Bakery Marzipan Coffee Cake Recalled for Undeclared Yellow #5

    NRS Enterprises, Inc. dba Sunflour Bakery is recalling Marzipan/Almond Coffee Cake because Yellow #5 was not declared on the label. The product was distributed in California.

    Product
    Marzipan/Almond Coffee Cake, 16 oz, in clear poly bags
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1125-2024·2024-04-03

    Dietary Supplement Recall: TestoFREAK Contains Sub-Potent Zinc Levels

    VRA Formulations is recalling TestoFREAK Maximize Testosterone Dietary Supplement due to sub-potent zinc content. Affected bottles were distributed domestically through internet sales.

    Product
    TestoFREAK Maximize Testosterone Dietary Supplement 60 capsules per dark amber bottle, 100 bottles per case
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1376-2024·2024-04-03

    Access Substrate Reagent Bottles Recalled for Missing Product Labels

    Beckman Coulter is recalling Access Substrate reagent bottles (REF 81906) due to missing product labels on certain manufacturing lots. While the missing labels may delay patient test result reporting, no incorrect results have been reported.

    Product
    Access Substrate, REF 81906, For use with the Access Immunoassay Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1106-2024·2024-04-03

    Food Recall: German Home Bakery Poppy Coffee Cake for Undeclared Yellow #5

    NRS Enterprises, Inc. (Sunflour Bakery) recalled 197 loaves of German Home Bakery Poppy Coffee Cake due to undeclared Yellow #5 dye. The product was distributed in California.

    Product
    German Home Bakery Poppy Coffee Cake, 16 oz, clear poly bag
    Category
    Food
    Distribution
    1 state
  • LowFDA (Food)·F-1095-2024·2024-04-03

    Juice Recall: Incorrect SKU Label on Golden Sunrise Cold Pressed Juice

    Pressery, LLC is recalling Golden Sunrise Cold Pressured Juice due to an incorrect SKU label. No illnesses or injuries have been reported.

    Product
    The label reads, "Golden Sunrise Cold Pressured Juice Carrot, Orange, Pineapple, Lemon, Ginger & Turmeric 11 fl. oz."
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1078-2024·2024-03-27

    Fresh & Ready Chicken Torta Sandwich Recalled for Listeria Contamination

    Fresh & Ready Foods LLC is recalling Fresh & Ready Chicken Torta Sandwich products (use-by dates 02/03/2024–02/22/2024) due to Listeria monocytogenes contamination. Affected products were distributed to California, Nevada, Utah, and Arizona.

    Product
    Fresh & Ready Chicken Torta Sandwich 9 oz UPC 8290690706
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-1082-2024·2024-03-27

    Stonewall Kitchen Gluten Free Doughnut Mix Recalled for Undeclared Wheat

    Stonewall Kitchen is recalling Cinnamon Sugar Doughnut Mix (Gluten Free) with use-by dates of March 9-10, 2025, because units contain undeclared wheat. Consumers with wheat allergies or celiac disease should not consume this product.

    Product
    Stonewall Kitchen Cinnamon Sugar Doughnut Mix; Gluten Free; Home-Baked & Gluten Free; Net Wt. 18oz (510g); UPC: 1138131332
    Category
    Food
    Distribution
    44 states
  • CriticalFDA (Food)·F-1077-2024·2024-03-27

    Fresh & Ready Ham Torta Sandwich recalled for Listeria monocytogenes contamination

    Fresh & Ready Foods LLC recalled Fresh & Ready Ham Torta Sandwich (9 oz) due to possible Listeria monocytogenes contamination. The recall affects products distributed in California, Nevada, Utah, and Arizona with use-by dates February 3–22, 2024.

    Product
    Fresh & Ready Ham Torta Sandwich 9 oz UPC 8290690707
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-1089-2024·2024-03-27

    HEB Poblano Caesar Dressing recalled for Listeria monocytogenes contamination

    Reser's Fine Foods is recalling HEB Poblano Caesar Dressing due to Listeria monocytogenes contamination from repackaged Cotija cheese. The recall affects 2495 cases distributed across 16 states.

    Product
    FCF Item 403953, HEB Poblano Caesar Dressing, 12oz. glass bottle, 6 bottles per case. UPC 41220 94807
    Category
    Food
    Distribution
    16 states
  • CriticalFDA (Food)·F-1087-2024·2024-03-27

    Don Pancho Fiesta Sauces Recalled for Listeria Monocytogenes Contamination

    Reser's Fine Foods is recalling Don Pancho Fiesta 3 Pack Everything Sauce due to potential Listeria monocytogenes contamination from recalled Cotija cheese repackaged into these ready-to-eat products.

    Product
    Item # 407034, Don Pancho Fiesta 3 Pack Everything Sauce. Each pack consists of Cilantro Lime Crema, Baja-Style Crema, Chipotle Crema. 3/12oz glass bottles per pack, 6 packs per case. UPC on 3-pack box: 0 71117 00741 1.
    Category
    Food
    Distribution
    16 states
  • SevereFDA (Food)·F-1090-2024·2024-03-27

    Costco Southwest Wrap Kit Recalled for Listeria Contamination

    Reser's Fine Foods is recalling Costco Southwest Wrap Kits due to Listeria monocytogenes contamination. The product was distributed across 16 states.

    Product
    FCF Item 406957, Costco Item # 1744097, Club COSTCO SW Wrap Kit, Costco Service Deli, 2/8.15 lbs. Net Wt. 16.31 lbs., UPC 0 13454 38424 4. Costco assembled and sold product as Southwest Wrap with Sauce, item #29433.
    Category
    Food
    Distribution
    16 states