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.

15651–15675 of 27263

  • HighFDA (Drugs)·D-0995-2023·2023-08-09

    Neonatal TPN Starter Bags Recalled Due to Sterility Validation Deficiency

    Central Admixture Pharmacy Services is recalling 80 bags of Neonatal TPN Starter Bag nationwide due to insufficient sterility assurance. The deficiency stems from lacking validation data for decontamination cycles.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 2.5%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0402-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1357-2023·2023-08-09

    Antonio's Rustico Pizza Dough recalled for undeclared soy flour

    Cassanos Inc is recalling Antonio's Rustico Pizza Dough (15in) distributed across nine states due to undeclared soy flour. Consumers with soy allergies are at risk.

    Product
    Antonio's Rustico Pizza Dough: packaged as 15in
    Category
    Food
    Distribution
    9 states
  • HighFDA (Drugs)·D-1011-2023·2023-08-09

    Neonatal TPN Starter Bag Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 420 neonatal TPN starter bags due to lack of sterility assurance and validation data for decontamination cycles. The recalled lots were distributed nationwide.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10% with CALCIUM and HEPARIN, IV Bags, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0422-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1365-2023·2023-08-09

    Outshine Strawberry Fruit Bars Recalled for Undeclared Milk Allergen

    Dreyer's Grand Ice Cream is recalling Outshine No Sugar Added Strawberry Fruit Bars due to undeclared milk allergen. Consumers with milk allergies in affected states should not consume this product.

    Product
    Outshine No Sugar Added Strawberry Fruit Bars Brand name: Outshine; Unit size:14.7 fl oz carton with 6 bars; Container description: paper cartons; Total package size: 6 bars per case; Storage instructions: frozen
    Category
    Food
    Distribution
    17 states
  • HighFDA (Devices)·Z-2292-2023·2023-08-09

    Medline procedural kits may contain non-sterile ultrasound gel

    Medline is recalling 4,900 sterile procedural kits used for arterial line insertion because the ultrasound gel component may not meet sterility specifications.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ART LINE KIT ICH OR, Model Number: ART900; b. ART LINE SECUREMENT KIT W/LIDOCAINE, Model Number: DT22570; c. ARTERIAL BUNDLE NO CATHETER, Model Number: ART
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0989-2023·2023-08-09

    FDA Recalls IV Potassium Phosphate Solution Due to Sterility Assurance Issues

    Central Admixture Pharmacy Services is recalling 7,469 bags of potassium phosphate IV solution nationwide because decontamination validation data is lacking, creating a sterility assurance gap.

    Product
    potassium phosphate 15 mmole added to 0.9% sodium Chloride 250 mL, IV Bag, RX Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6060-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1066-2023·2023-08-09

    FDA Recalls PHENYLephrine Syringes Due to Sterility Validation Failure

    FDA is recalling 81,073 PHENYLephrine syringes manufactured by Central Admixture Pharmacy Services. The manufacturer lacks validation data for its sterilization processes, so the syringes may not be sterile.

    Product
    PHENYLephrine in 0.9% sodium chloride, 1000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6009-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1037-2023·2023-08-09

    Cardioplegia Solution Recalled Due to Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling 356 bags of cardioplegia solution distributed nationwide. The recall is due to lack of assurance of sterility, as validation data for decontamination cycles is lacking.

    Product
    Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, IV Bag, total volume = 1047 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0211-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2266-2023·2023-08-09

    Endobronchial Cytology Needles Recalled for Electromagnetic Sensor Malfunction

    Olympus is recalling endobronchial navigation needles because an electromagnetic sensor malfunction can disable navigation guidance during medical procedures, potentially causing procedural delays.

    Product
    Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0984-2023·2023-08-09

    IV Oxytocin Solution Recall Due to Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling 9,504 IV bags of oxytocin mixed with Lactated Ringer's solution because validation data for sterilization cycles is lacking. The product was distributed nationwide.

    Product
    oxyTOCIN 20 units added to Lactated Ringer's 1000 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6038-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1006-2023·2023-08-09

    Neonatal TPN Starter Bags Recalled Over Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling 108 Neonatal TPN Starter Bags (Lot 36-256338) due to lack of assurance of sterility and insufficient validation data for decontamination cycles.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0406-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2297-2023·2023-08-09

    Procedural kits containing Turkuaz ultrasound gel recalled for sterility failure

    Medline Industries recalls approximately 97,677 procedural kits containing Turkuaz Ultrasound Gel due to potential sterility specification failures. The affected kits were distributed worldwide from April 1, 2020 to April 28, 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. (13) STC IVC FILTER/ANGIOGRAM, Model Number: DYNJ908249A; b. 16CM 3L 7FR CVC INSERTION BUNDLE, Model Numbers: ECVC7410A; c. 16CM 7F 3L CVC MAX BARRIER INSERTION,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1327-2023·2023-08-09

    Toffee Peanuts Recalled for Undeclared Allergens: Tree Nuts and Wheat

    Houston Pecan Company recalls Toffee Peanuts in 5-pound bags due to undeclared allergens (tree nuts and wheat) from cross-contamination in products distributed in Texas and online.

    Product
    Toffee Peanuts, Peanuts, Sugar, Salt packaged in 5 pound bags
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2247-2023·2023-08-09

    VERITAS Advanced Infusion and Fluidics Packs Recalled for Weld Defect

    Johnson & Johnson is recalling 148,941 VERITAS Advanced Infusion and Fluidics surgical packs due to weld defects that could cause vacuum failure during surgery, potentially leading to surgical delays and temporary eye swelling.

    Product
    VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2287-2023·2023-08-09

    ProPlan CMF Mandible Surgical Guides Recall for Wrong Version

    Materialise recalls ProPlan CMF mandible surgical guides because wrong versions were shipped prior to a redesign. Healthcare facilities should verify they have the correct version.

    Product
    ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. Identification number: SD900.101
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0970-2023·2023-08-09

    Vancomycin IV Bags Recalled Over Sterility Assurance Concerns Nationwide

    Central Admixture Pharmacy Services is recalling vancomycin 2 g/500 mL IV bags nationwide due to lack of sterility assurance. Validation data for decontamination cycles is not available.

    Product
    vancomycin 2 g/500 mL added to 0.9% Sodium Chloride, 4 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6078-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1358-2023·2023-08-09

    OSU Premium Dough on Parchment Recalled for Undeclared Soy Flour

    Cassanos Inc recalls OSU Premium Dough on Parchment due to undeclared soy flour. Consumers with soy allergies should not consume the product.

    Product
    OSU Premium Dough on Parchment: packaged as 14in
    Category
    Food
    Distribution
    9 states
  • HighFDA (Drugs)·D-0960-2023·2023-08-09

    PHENYLephrine Intravenous Bags Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling PHENYLephrine IV bags distributed nationwide. The company could not prove the products were properly sterilized.

    Product
    PHENYLephrine, 10mg/250ml added to 0.9% sodium chloride, 40mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6058-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2320-2023·2023-08-09

    Medical procedural kits recalled for potential sterile ultrasound gel defect

    Medline is recalling 93,587 custom procedural kits worldwide because the sterile ultrasound gel component may not meet sterility specifications.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR. ROSEN VEIN PACK, Model Number: DYNJ67517; b. DR. VANBOSSE LOWER EXT PACK, Model Number: DYNJ51416B; c. DRAINAGE TRAY, Model Number: DYNJ42913, DYNJ42913A;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2305-2023·2023-08-09

    Medline procedural kits with ultrasound gel may not meet sterility specifications

    Medline Industries recalls 146,157 custom procedural kits distributed April 2020 to April 2023 because the sterile ultrasound gel component may not meet sterility specifications.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. A V FISTULA, Model Number: DYNJ65711; b. ACCESS CATHETER, Model Number: DYNJ64141A; c. ACCESS PICC PACK, Model Number: DYNJ40682B; d. ADULT EPIV INSERTION T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0974-2023·2023-08-09

    Heparin IV Bags Recalled Due to Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling heparin IV bags due to lack of sterility assurance and missing validation data for decontamination cycles. The recall affects 358 bags distributed nationwide.

    Product
    heparin 2500 units added to 0.9% sodium chloride 250mL, CONCENTRATION = 10 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8000-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1314-2023·2023-08-09

    Almond Products Recalled for Undeclared Tree Nut and Peanut Allergens

    Houston Pecan Company is recalling multiple almond products due to potential undeclared tree nuts, peanuts, and wheat from cross-contamination. Affected 5-pound bags were sold in Texas and online prior to May 25, 2023.

    Product
    Whole Natural Almonds packaged in 5 pound bag; Whole Blanched Almonds packaged in 5 pound bag; Sliced Blanched Almonds packaged in 5 pound bag; Sliced Natural Almonds packaged in 5 pound bag; Almond Flour packaged in 5 pound bag; Smoked Almonds packaged in 5 pound bag; Slivered A
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0998-2023·2023-08-09

    Neonatal TPN Bags Recalled Due to Sterility Assurance Failure

    Central Admixture Pharmacy Services recalls 420 bags of neonatal TPN containing amino acids and dextrose due to lack of assurance of sterility. Validation data for decontamination cycles was not available.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0428-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2283-2023·2023-08-09

    X-ray Imaging System Carriage Bolts May Loosen or Break

    Philips Allura Xper FD10 and FD20 X-ray systems may have loose or broken bolts supporting the FlexMove Carriage and cracks in the suspension rail. Affected units distributed worldwide; users should inspect equipment and contact manufacturer.

    Product
    Allura Xper FD10 and FD20. X-ray Imaging System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1065-2023·2023-08-09

    Morphine Injectable Syringes Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 720 syringes of morphine due to lack of validation data for sanitization cycles, which creates uncertainty about product sterility. The product was distributed nationwide.

    Product
    morphine in 0.9% sodium chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2040-3
    Category
    Drug
    Distribution
    Distributed nationwide