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.

15551–15575 of 27263

  • HighFDA (Devices)·Z-2328-2023·2023-08-09

    Medline Procedural Kit Ultrasound Gel Sterility Specification Failure

    Medline Industries is recalling procedural kits containing ultrasound gel that may not meet sterility specifications. The affected kits were distributed to healthcare facilities worldwide from 2020 to 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR MOTT DRAPE PACK, Model Number: DYNJ42065B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2331-2023·2023-08-09

    Medline Procedural Kits Recalled Due to Sterility Specification Failure

    Medline Industries recalls 15,945 Custom Sterile and Non-Sterile Procedural Kits due to potential failure of the Turkuaz ultrasound gel component to meet sterility specifications. The kits were distributed worldwide between April 2020 and April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIO, Model Number: DYNJ905151A; b. ANGIO/VENO PACK, Model Number: DYNJ58346A; c. ANGIOGRAPHIC PACK, Model Number: DYNJ57442C, DYNJ64081A; d. ANGIOGRA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1071-2023·2023-08-09

    Ketamine Injection Recalled Due to Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 2,994 syringes of ketamine injection distributed nationwide due to lack of validated sterilization procedures that ensure product sterility.

    Product
    ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-3022-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0993-2023·2023-08-09

    Neonatal IV Nutrition Bags Recalled Due to Sterility Assurance Defect

    Central Admixture Pharmacy Services is recalling 188 neonatal TPN bags nationwide because sterility assurance cannot be guaranteed. Validation data for decontamination cycles is lacking.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10% with CALCIUM and HEPARIN, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0416-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0969-2023·2023-08-09

    Vancomycin IV bags recalled due to sterility assurance failure

    Central Admixture Pharmacy Services is recalling 6,782 bags of vancomycin IV bags distributed nationwide due to lack of validation data for decontamination cycles, which compromises sterility assurance.

    Product
    vancomycin 1.75g added to 0.9% sodium chloride 500mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7060-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0976-2023·2023-08-09

    FDA Recalls Oxytocin IV Bags Due to Sterility Assurance Deficiency

    Central Admixture Pharmacy Services is recalling oxytocin IV bags nationwide due to insufficient validation of sterilization decontamination processes. The recall affects 6,037 bags distributed across multiple lots.

    Product
    oxyTOCIN 20 units added to 0.9% sodium chloride 1,000 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6043-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0968-2023·2023-08-09

    Vancomycin IV Bags Recalled Due to Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 2,914 bags of vancomycin IV medication nationwide due to lack of assurance of sterility caused by missing validation data for decontamination cycles.

    Product
    vancomycin 1.5 g/250mL added to 5% dextrose, 6 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6075-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1025-2023·2023-08-09

    Cardioplegia Solution Recalled Due to Sterility Assurance Deficiency

    Central Admixture Pharmacy Services recalls Leesburg Cardioplegia Solution due to inadequate sterilization validation. The recall affects 36 bags distributed nationwide.

    Product
    CARDIOPLEGIA SOLUTION, LEESBURG CARDIOPLEGIA, IV Bag, Total Volume = 1030.2 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0218-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1041-2023·2023-08-09

    FDA Recalls Cardioplegia Solution for Lacking Sterility Validation Data

    Central Admixture Pharmacy Services is recalling a cardioplegia solution used during heart surgery due to insufficient validation data for sterilization cycles. The 104-bag recall covers products distributed nationwide.

    Product
    CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1 non-enriched, Low Potassium, IV Bag, Total Volume = 300 mL, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC 72196-0215-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1072-2023·2023-08-09

    Fentanyl-bupivacaine injectable drug recalled due to sterility concerns

    Central Admixture Pharmacy Services is recalling 896 bags of fentanyl-bupivacaine injectable solution nationwide due to lack of sterility assurance. The FDA Class II recall affects compounded pain medication lacking adequate sterilization validation.

    Product
    fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2082-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1076-2023·2023-08-09

    Rocuronium Syringes Recalled for Lack of Sterility Validation

    Central Admixture Pharmacy Services is recalling rocuronium syringes due to lack of validation data for sanitization cycles, which cannot assure sterility. The recall affects 10,065 syringes distributed nationwide.

    Product
    rocuronium, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6010-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0983-2023·2023-08-09

    FDA Recalls Oxytocin IV Bags Due to Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling 463 bags of oxytocin IV solution nationwide due to inadequate validation data for sterilization processes. The product may not meet FDA sterility standards required for injectable medications.

    Product
    oxyTOCIN, 20 units added to dextrose 5%/lactated ringers 1000 mL, IV Bag, Rx Only, This drug was repacked by CAPS, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6031-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1348-2023·2023-08-09

    DOUBLEDAY'S Premium Dough Recalled for Undeclared Soy Allergen

    DOUBLEDAY'S Premium Dough packages may contain undeclared soy flour, posing risk to consumers with soy allergies. The recall affects 24,575 cases distributed across nine states.

    Product
    DOUBLEDAY'S Premium Dough on Parchment: packaged as 8in, 9in, 10in, 12 in
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-1360-2023·2023-08-09

    belVita Breakfast Sandwich Recall: Undeclared Peanut Allergen

    Mondelez Global LLC recalls belVita Breakfast Sandwich (Dark Chocolate Creme variety) due to undeclared peanut allergen from cross contamination. The product was distributed to all 50 states.

    Product
    belVita Breakfast Sandwich, Dark Chocolate Creme variety (8 - 14.08 oz packages)
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1312-2023·2023-08-09

    Mediterranean Salad Recalled for Undeclared Allergens Including Milk

    Eat Good LLC is recalling Mediterranean Salad distributed in Idaho, Montana, and Washington due to missing allergen declarations for milk, sulfites, and FD&C Yellow #5.

    Product
    Mediterranean Salad is a food service refrigerated product, packaged in 5lb flexible plastic packages, 2/5lb. packages are packed in cardboard cases. The salads are removed from the package and sold by the pound from deli display cases at the grocery stores. Mediterranean Sal
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2329-2023·2023-08-09

    Ultrasound Gel in Medline Procedural Kits Recalled Over Sterility Specification Concerns

    Medline Industries recalled approximately 154,900 Custom Sterile and Non-Sterile 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. PROBE COVER PACK, Model Number: DYNDA1219
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2254-2023·2023-08-09

    Zimmer Periarticular Locking Plate recalled due to thread form defect

    Zimmer Periarticular Locking Plates have a thread form defect that prevents surgical screws from properly mating with the plate. 75 units distributed across multiple U.S. states and internationally.

    Product
    Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 159 mm Length-Indicated for temporary internal fixation and stabilization of osteotomies and fractures, including comminuted fractures, supracondylar fractures, intra-articular and extra-articular cond
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Drugs)·D-0981-2023·2023-08-09

    Heparin intravenous bags recalled due to sterility assurance failure

    Central Admixture Pharmacy Services is recalling 448 bags of heparin 7500 units in 0.9% sodium chloride IV solution due to lack of assurance of sterility. Validation data for decontamination cycles was not established.

    Product
    heparin 7500 units added to 0.9% sodium chloride 1000mL, CONCENTRATION = 7.5 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7009-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1331-2023·2023-08-09

    Apple Rings Recalled for Undeclared Tree Nuts, Peanuts, Wheat

    Houston Pecan Company recalls Apple Rings in 5-pound bags due to potential undeclared allergens from cross-contamination with tree nuts, peanuts, and wheat.

    Product
    Apple Rings Sulfur Dioxide Added packaged in 5 pound bags; Apple Rings, 1/2 pound bag
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2258-2023·2023-08-09

    Philips CT scanner heat exchanger box may detach and cause injury

    The metal mounting box on the rotating scanner of the Incisive CT system may become detached and contact other components, potentially injuring users or causing system shutdown.

    Product
    Incisive CT-Computed Tomography X-Ray System Model: 728143
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0987-2023·2023-08-09

    NORepinephrine IV Bags Recalled for Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling NORepinephrine 4 mg/250 mL IV bags due to lack of sterility assurance caused by insufficient validation of decontamination cycles. The affected lots were distributed nationwide.

    Product
    NORepinephrine 4 mg/250 mL added to 0.9% sodium chloride 16 mcg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8097-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1073-2023·2023-08-09

    ePHEDrine Injectable Syringes Recalled Over Sterility Assurance Gaps

    Central Admixture Pharmacy Services is recalling 8,942 ePHEDrine syringes nationwide due to lack of validation data for sterilization procedures, creating a potential sterility risk for injectable medications.

    Product
    ePHEDrine in 0.9% sodium chloride, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6004-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2295-2023·2023-08-09

    Medline Procedural Kits Recalled: Ultrasound Gel Sterility Concerns

    Medline recalls sterile and non-sterile procedural kits containing ultrasound gel that may not meet sterility specifications. 29,126 units distributed in US and internationally.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAM TRAY, Model Number: DYNJ33638J; b. BLOCK TRAY, Model Number: DYNJRA1543; c. BMT- NERVE PERIPH PK, Model Number: DYNJRA1247; d. CVOR ANGIOGRA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0955-2023·2023-08-09

    Vancomycin IV Bags Recalled Due to Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling 15,304 bags of vancomycin IV solution due to lack of validation data confirming proper sterilization of the product.

    Product
    vancomycin 1.25 g/250 mL added to 0.9% Sodium Chloride, 5 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6074-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0979-2023·2023-08-09

    Heparin IV Bags Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 5,834 bags of heparin 5000 units/500mL IV bags nationwide due to insufficient validation of sterilization processes, creating potential contamination risk.

    Product
    heparin 5000 units/500mL added to 0.9% sodium chloride, 10 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7023-1
    Category
    Drug
    Distribution
    Distributed nationwide