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.

15701–15725 of 27263

  • HighFDA (Drugs)·D-0958-2023·2023-08-09

    Epinephrine IV solution bags recalled due to inadequate sterilization validation

    Central Admixture Pharmacy Services is recalling 6,784 bags of Epinephrine IV solution nationwide because validation data for decontamination and sterilization processes is lacking, creating a potential contamination risk.

    Product
    EPINEPHrine added to dextrose 5%, 4mg/250ml, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7018-1.
    Category
    Drug
    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 (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-2256-2023·2023-08-09

    Siemens Pro.specta Emission CT Systems Sensor Issue Reduces Image Resolution

    Siemens Pro.specta CT imaging systems may produce reduced image quality due to sensors triggering earlier than expected, potentially affecting diagnostic accuracy. Affected units were distributed across the US and internationally.

    Product
    The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly: (a) Symbia Pro.specta Q3, Model 11364751; (b) Symbia Pro.specta X3, Model 11364752; (c) Symbia Pro.specta X7, Model 11364753.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Food)·F-1354-2023·2023-08-09

    San Marco Premium Dough recalled for undeclared soy flour allergen

    Cassanos Inc is recalling San Marco Premium Dough on Parchment due to undeclared soy flour. Consumers with soy allergies who consume this product face allergic reaction risk.

    Product
    San Marco Premium Dough on Parchment: packaged as 8in, 14in
    Category
    Food
    Distribution
    9 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 (Drugs)·D-0982-2023·2023-08-09

    FDA Recalls Neostigmine Injectable Syringes Due to Sterility Assurance Deficiency

    FDA is recalling Central Admixture Pharmacy Services' neostigmine injectable syringes due to lacking validation data for sterilization decontamination cycles, raising concerns about product sterility.

    Product
    neostigmine 5 mg/5mL (1mg/mL) Syringe, Rx only, This drug was repacked by CAPS, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6065-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0963-2023·2023-08-09

    IV Phenylephrine bags recalled for lack of sterility assurance

    Central Admixture Pharmacy Services recalled 9,432 IV bags containing phenylephrine due to lack of assurance of sterility and insufficient validation data for decontamination cycles. The product was distributed nationwide.

    Product
    PHENYLephrine, 40mg/250ml, added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6092-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1057-2023·2023-08-09

    HYDROmorphone Injectable Syringes Recalled Due to Unvalidated Sanitization Cycles

    Central Admixture Pharmacy is recalling HYDROmorphone injection syringes nationwide due to lack of validated sanitization cycles, which compromises sterility.

    Product
    HYDROmorphone in Dextrose 5%, 0.5 mg/5 mL (0.1 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2013-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0996-2023·2023-08-09

    Neonatal TPN solution recalled for lack of sterility assurance

    Central Admixture Pharmacy Services is recalling 296 bags of neonatal TPN starter solution due to lacking validation data for decontamination cycles, raising concerns about sterility assurance.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/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: 72196-0418-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1317-2023·2023-08-09

    Pistachios Recalled Due to Undeclared Tree Nuts, Peanuts, and Wheat

    Houston Pecan Company recalls pistachios in 5-pound bags due to potential undeclared allergens: tree nuts, peanuts, and wheat. Affected products were purchased before May 25, 2023, and distributed in Texas and via online sales.

    Product
    Pistachios Halves & Pieces packaged in 5 pound bags; Pistachios Roasted & Salted packaged in 5 pound bags; Pistachios Raw packaged in 5 pound bags
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2316-2023·2023-08-09

    Medline Procedural Kits Recalled for Potential Sterility Failure in Ultrasound Gel

    Medline is recalling 6,733 custom procedural kits due to potential sterility failure in the Turkuaz ultrasound gel component. The gel may not meet required sterility specifications.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC PACK, Model Number: DYNJ46967F; b. ENDOVENOUS ABLATION PACK, Model Number: DYNJ64059; c. ENDOVENOUS CORE PACK: DYNJ62557; d. TVS4000 ENDOVENOUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1315-2023·2023-08-09

    Walnuts Recalled for Undeclared Tree Nuts, Peanuts, and Wheat Allergens

    Houston Pecan Company is recalling 5-pound bags of walnuts that may contain undeclared tree nuts, peanuts, and wheat due to cross-contamination. Affected products were sold in Texas and through internet sales.

    Product
    Walnut Halves packaged in 5 pound bag; Walnuts Medium Pices packaged in 5 pound bags; Walnuts Halves & Large Pieces packaged in 5 pound bags
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0988-2023·2023-08-09

    Norepinephrine IV bags recalled for sterility validation deficiency

    Central Admixture Pharmacy Services recalled 80 bags of norepinephrine IV solution due to lack of sterility assurance and insufficient validation data for decontamination cycles. Product was distributed nationwide.

    Product
    norepinephrine, 16 mg, added to dextrose 5% 250 mL, IV Bag, CONCENTRATION 64 mcg/mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC 72196-8095-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2298-2023·2023-08-09

    Medical procedural kits recalled due to sterility concerns with ultrasound gel

    Medline recalls 76,870 procedural kits because the ultrasound gel component may not meet sterility standards. Kits were distributed nationwide and internationally from April 2020 through April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CRMC MINOR IR PROCEDURE PK-LF, Model Numbers: DYNJ61099B, DYNJ61099C; b. CRMC TUNNEL CATH TRAY-LF, Model Numbers: DYNJ61118C, DYNJ61118F; c. CUSTOM ANGIO TRAY, M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0961-2023·2023-08-09

    Phenylepherine IV bags recalled due to sterility assurance concerns

    Central Admixture Pharmacy Services is recalling over 8,300 phenylepherine IV bags nationwide because sterilization procedures were not adequately validated. Sterility cannot be assured for the affected units.

    Product
    PHENYLephrine 20mg/250ml added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7025-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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 (Drugs)·D-0980-2023·2023-08-09

    Neonatal TPN Starter Bags Recalled Due to Sterility Validation Concerns

    Central Admixture Pharmacy Services recalled 52 neonatal TPN starter bags nationwide due to lack of validation data for sterilization processes, raising concerns about sterility assurance.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 6%/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: 72196-0430-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2249-2023·2023-08-09

    Gore Tips Set Device Recall: Incorrect Expiration Date Labeling

    Creganna Medical Devices is recalling three lots of Gore Tips Set Device due to incorrect expiration date labeling. Affected devices may be used past their actual expiration date.

    Product
    Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2250-2023·2023-08-09

    Ecolab Medical Device Drapes Recalled for Naphthalene Odor

    Microtek Medical Inc. is recalling certain lots of Ecolab sterile medical device drapes due to naphthalene odor. The recall affects five models distributed in the United States and Canada.

    Product
    Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape, 91 cm x 51 cm (36 in x 20 in), Model 63620RT, pkgd. 25/case, sterile; (2) Ecolab Microtek Banded Bag with Elastic Opening, Circular, 102 cm (40 in), Model 60040S, pkgs. 25/case, sterile; (3) Ecolab M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2251-2023·2023-08-09

    Surgical table drapes and infection control kits recalled for naphthalene odor

    Microtek Medical Inc. is recalling certain lots of surgical table drapes and infection control kits due to detection of naphthalene odor. The affected products are distributed nationwide in the US and in Canada.

    Product
    Equipment and table drapes and Surgical Room Turnover (SRT) Kits: (1) Ecolab Absorbent Table Cover W/Transfer Sheet & Armboard Covers, Model #ABTSLSAN, 20/case, non-sterile; (2) Microtek/Ecolab/CleanOp Absorbent Table Cover w/Transfer Sheet, Model ABTSLSN, 25/case, non-steril
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1307-2023·2023-08-09

    Golden Loaf Bakers Flour Unbleached Flour Recalled for Potential Filth

    Big J Mill & Elevator Company is recalling Golden Loaf Bakers Flour Unbleached Flour due to potential filth contamination. Approximately 900 cases were distributed to consignees in Utah.

    Product
    Golden Loaf Bakers Flour Unbleached Flour; packaged in plastic 5lb bags. 4 bags per case.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1306-2023·2023-08-09

    Big J All Purpose Unbleached Flour Recalled for Potential Filth Contamination

    Big J Mill & Elevator Company is recalling Big J All Purpose Flour Unbleached Flour due to potential filth contamination. The recalled product was distributed to consignees in Utah.

    Product
    Big J All Purpose Flour Unbleached Flour; packaged in plastic 5lb bags. 4 bags per case.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0946-2023·2023-08-09

    Prescription oral drug solution recalled due to manufacturing quality deviation

    The Ritedose Corporation is recalling Cromolyn Sodium Oral Solution (Concentrate) due to a manufacturing deviation. Lot 23CE2, distributed nationwide, was released prior to obtaining required supplier approval.

    Product
    CROMOLYN SODIUM ORAL SOLUTION (CONCENTRATE) — CROMOLYN SODIUM ORAL SOLUTION (CONCENTRATE) (CROMOLYN SODIUM ORAL SOLUTION (CONCENTRATE))
    Category
    Drug
    Distribution
    Distributed nationwide