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.

17401–17425 of 88183

  • HighFDA (Drugs)·D-1059-2023·2023-08-09

    Fentanyl IV Bags Recalled for Lack of Sterilization Validation

    Central Admixture Pharmacy Services is recalling 19,014 bags of fentanyl IV injection nationwide due to lack of validated sterilization processes, which could affect product sterility.

    Product
    fentaNYL in 0.9% sodium chloride, 1000 mcg/100 mL, (10 mcg/mL), 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-4
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2334-2023·2023-08-09

    Medline sterile procedural kits recalled for potential sterility specification failures

    Medline is recalling custom sterile and non-sterile procedural kits containing Turkuaz Ultrasound Gel due to potential sterility specification failures. The kits were distributed worldwide to hospitals and medical facilities.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. C V MINOR PACK, Model Number: DYNJ64862A; b. DBD-C SECTION ADM, Model Number: DYKL1816; c. FETAL SURGERY, Model Number: DYNJ908118A;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2319-2023·2023-08-09

    Medline sterile procedural kits recalled for potentially non-sterile gel

    Medline is recalling 83,541 procedural kits because the included ultrasound gel component may not meet required sterility specifications.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 7F, 20CM TRIPLE LUMEN CVC BUNDLE, Model Number: ECVC4740; b. A V GRAFT, Model Number: DYNJ36212C; c. AAA, Model Number: DYNJ905651, DYNJ905651A, DYNJ905651B…
    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-1031-2023·2023-08-09

    Cardioplegia Solution Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling Cardioplegia Solution (100 mEq K) due to inadequate validation of decontamination processes. The recall affects 284 units distributed nationwide. Affected facilities should discontinue use and contact the manufacturer.

    Product
    CARDIOPLEGIA SOLUTION, 100 mEq K, Induction 8:1, High Potassium / Low dextrose, IV Bag, total volume = 500 mL, RX Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0107-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1347-2023·2023-08-09

    Prima Guida Sheeted Pizza Dough recalled for undeclared soy flour allergen

    Cassanos Inc is recalling Prima Guida Traditional Homestyle Sheeted Pizza Dough in multiple sizes due to undeclared soy flour. Consumers with soy allergies should not consume this product.

    Product
    Prima Guida Traditional Homestyle Sheeted Pizza Dough: packaged as 7in, 8in, 9in, 10in (regular), 10in (thin), 12in (thin), 12in (regular), 14 in (regular), 14in (thin), 16in (thin), 16in (regular), 18in
    Category
    Food
    Distribution
    9 states
  • HighFDA (Drugs)·D-1045-2023·2023-08-09

    Fentanyl Injection Syringes Recalled for Sterilization Validation Failure

    Central Admixture Pharmacy Services recalls 150 fentanyl injection syringes nationwide because sterilization procedures were not properly validated.

    Product
    fentaNYL, 100 mcg/2 mL, (50 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2313-2023·2023-08-09

    Sterile Procedural Kits Recalled Due to Potential Ultrasound Gel Sterility Failure

    Medline Industries is recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel because the gel component may not meet sterility specifications. The kits are distributed worldwide for dialysis procedures.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number: MNS10750A; b. STD INSERTION/DIALYSIS INSERTION TRAY, Model Number: CVI3845;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1054-2023·2023-08-09

    Fentanyl Injectable Syringes Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling approximately 2,082 fentanyl injectable syringes distributed nationwide due to lack of validation data for sanitization cycles, which cannot assure product sterility.

    Product
    fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-3
    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 (Devices)·Z-2333-2023·2023-08-09

    Medline Surgical Procedural Kits Recalled Due to Sterility Concerns

    Medline Industries is recalling approximately 7,462 custom surgical procedural kits containing ultrasound gel because the gel component may not meet sterility specifications. The recall affects kits distributed worldwide since April 2020.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CHN OR DAVINCI PROSTATE, Model Number: DYNJ902540N; b. CUSTOM GYN, Model Number: DYNJ63257B; c. DBD-AMNIOCENTESIS PACK-LF, Model Number: DYNJ0771979C…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0964-2023·2023-08-09

    Phenylephrine IV bags recalled due to sterility validation gaps

    Central Admixture Pharmacy Services has recalled 472 phenylephrine IV bags distributed nationwide due to insufficient validation data for sterilization processes.

    Product
    phenylephrine 50 mg added to 0.9% sodium chloride 250mL, CONCENTRATION = 200mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043. NDC:72196-7039-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1008-2023·2023-08-09

    Neonatal TPN Starter Bags Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services recalls 124 neonatal TPN starter bags nationwide due to lack of sterility assurance from missing decontamination validation data.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0421-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1078-2023·2023-08-09

    Phenylephrine Injection Syringes Recalled Due to Sterility Validation Failure

    Central Admixture Pharmacy Services Inc. is recalling 16,971 syringes of phenylephrine injection due to lack of validation data for sterilization processes. The product was distributed nationwide.

    Product
    PHENYLephrine in 0.9 sodium chloride, 400 mcg /10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6007-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-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.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0950-2023·2023-08-09

    Vancomycin IV Bags Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 4,824 bags of vancomycin IV medication nationwide due to inadequate validation of sterilization processes. The manufacturer cannot confirm proper sterility.

    Product
    vancomycin 1.25 g/250 mL added to dextrose 5%, 5 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix AZ 85043, NDC: 72196-6073-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2330-2023·2023-08-09

    Medline Procedural Kits Recalled for Potential Sterility Failure in Ultrasound Gel

    Medline Industries is recalling 7,040 custom sterile procedural kits containing ultrasound gel because the gel component may not meet sterility specifications, creating a potential infection risk.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. KIT TRIAGE ADMIT, Model Number: DYKA1456; b. KIT,ANTE PARTUM, Model Number: DYKL1844; c. MATERNAL ADMIT KIT, Model Number: DYKM2091
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1336-2023·2023-08-09

    Currants recalled for undeclared allergens: tree nuts, peanuts, wheat

    Houston Pecan Company, Inc. is recalling 5-pound bags of currants because they may contain undeclared tree nuts, peanuts, and wheat due to allergen cross contamination. The recall covers all bags purchased before May 25, 2023 in Texas and through internet sales.

    Product
    Currants packaged in 5 pound bags
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1343-2023·2023-08-09

    Sweet & Salty Mix Recalled for Undeclared Tree Nuts, Peanuts, and Wheat

    Houston Pecan Company is recalling Sweet & Salty Mix 5-pound bags due to potential undeclared tree nuts, peanuts, and wheat from cross-contamination. All bags purchased before May 25, 2023 are affected.

    Product
    Sweet & Salty Mix, Rst & Salted Peanuts, Rst & Salted Cashews, Raisins, Cranberries, Sunflower Seeds, Pumpkin Seeds, Sliced Almonds packaged in 5 pound bags
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-1046-2023·2023-08-09

    FDA Recalls Fentanyl Syringes for Sterility Assurance Failure

    Central Admixture Pharmacy Services Inc. has recalled 100 fentanyl syringes (Lot 17-273267) because validation data for sanitization cycles is lacking, preventing assurance of sterility. The product was distributed nationwide.

    Product
    fentaNYL, 250 mcg/5 mL, (50 mcg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2325-2023·2023-08-09

    Medline Procedural Kits Recalled for Potential Sterility Failure

    Medline is recalling 13,881 sterile procedural kits worldwide due to potential sterility failure in the ultrasound gel component. The affected kits are used in various medical insertion procedures.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC INFANT INSERTION PACK, Model Number: CVI4770A; b. INSERTION BUNDLE, Model Number: DT21275; c. MIDLINE DRESSING CHANGE KIT, Model Number: EBSI1464…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1363-2023·2023-08-09

    Mondelez Recalls belVita Breakfast Sandwiches for Undeclared Peanut Allergen

    Mondelez Global LLC is recalling belVita Breakfast Sandwiches (Dark Chocolate Creme variety) because they contain an undeclared peanut allergen due to cross contamination. Consumers with peanut allergies should not consume this product.

    Product
    belVita Breakfast Sandwich, Dark Chocolate Creme variety (192 - 2 lb 12 oz cartons per pallet)
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-1042-2023·2023-08-09

    FDA Recalls Fentanyl Injections Due to Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling 1,197 syringes of fentanyl injectable solution due to lack of validation for sterilization cycles. The product was distributed nationwide.

    Product
    fentaNYL in dextrose 5%, 300 mcg/30 mL, (10 mcg/mL), 30 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2001-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1334-2023·2023-08-09

    Mango Slices Recalled for Undeclared Tree Nuts, Peanuts, and Wheat

    Houston Pecan Company is recalling mango slices due to potential undeclared allergens: tree nuts, peanuts, and wheat. Affected products are 5-pound bags distributed in Texas and sold online.

    Product
    Mango Slices, Mango, Cane Sugar, Citric Acid, Calcium Chloride, Sulfur Dioxide packaged in 5 pound bags
    Category
    Food
    Distribution
    1 state