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.

15676–15700 of 27263

  • 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-0978-2023·2023-08-09

    Heparin IV Bags Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 11,824 bags of heparin IV solution nationwide. The recall is due to lack of assurance of sterility and missing validation data for decontamination cycles.

    Product
    heparin 4000 units/1000mL added to 0.9% sodium chloride, 4 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7022-1
    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 (Food)·F-1326-2023·2023-08-09

    Papaya Sweetened Recalled for Undeclared Tree Nuts, Peanuts, and Wheat

    Houston Pecan Company recalls Papaya Sweetened in 5-pound bags due to potential undeclared tree nuts, peanuts, and wheat from allergen cross contamination. Affected products were distributed in Texas and through internet sales.

    Product
    Papaya Sweetened packaged in 5 pound bags
    Category
    Food
    Distribution
    0 states
  • 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 (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-0962-2023·2023-08-09

    FDA Recalls Phenylephrine IV Bags Due to Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling phenylephrine IV bags nationwide due to insufficient sterility assurance and lack of validation data for decontamination cycles used in manufacturing.

    Product
    phenylephrine, 25mg added to 0.9% sodium chloride 250 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7011-1.
    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-1044-2023·2023-08-09

    HYDROmorphone Injectable Syringes Recalled Due to Sterility Assurance Concerns

    Central Admixture Pharmacy Services Inc is recalling HYDROmorphone injectable syringes because sterilization cycles were not validated. The recall affects 2,717 units distributed nationwide.

    Product
    HYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2010-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2318-2023·2023-08-09

    Medical Procedural Kits Recalled Due to Ultrasound Gel Sterility Risk

    Medline Industries is recalling 1,182 sterile and non-sterile procedural kits because the ultrasound gel component may not meet sterility specifications. The affected 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. CATH LAB BASIN PACK, Model Number: DYNJ69864A; b. DELNOR VASCULAR BASIN PACK, Model Number: DYNJ82257; c. FLAP PACK, Model Number: DYNJ60224C;
    Category
    Medical Device
    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 (Devices)·Z-2260-2023·2023-08-09

    Philips Incisive CT Scanner Mounting Box Poses Injury Risk

    A metal mounting box in the Incisive CT Power scanner may detach and potentially injure operators or cause system failure. Philips is recalling 53 affected units distributed worldwide.

    Product
    Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1346-2023·2023-08-09

    Cassano's Pizza King Dough Recalled for Undeclared Soy Flour

    Cassano's The Pizza King Proprietary Dough is being recalled due to undeclared soy flour. Consumers with soy allergies who consume this product may experience allergic reactions.

    Product
    Cassano's The Pizza King Proprietary Dough: packaged as 6in, 9in, 12in, 14in, and 16in
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-1308-2023·2023-08-09

    Caesar Pasta Salad Recall: Undeclared Wheat, Milk, Soybean

    Eat Good LLC recalls Caesar Pasta Salad for undeclared wheat, milk, and soybean allergens. Affected products were distributed in Idaho, Montana, and Washington.

    Product
    Caesar Pasta 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. Caesar Pasta Salad
    Category
    Food
    Distribution
    3 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-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
    0 states
  • 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-1060-2023·2023-08-09

    HYDROmorphone Injectable Syringes Recalled for Lack of Sterilization Validation

    Central Admixture Pharmacy Services is recalling 5,259 HYDROmorphone injectable syringes nationwide due to lack of validation data for sterilization, raising concerns about product sterility assurance.

    Product
    HYDROmorphone 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 71286-2012-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0994-2023·2023-08-09

    Neonatal TPN Bags Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services recalls 68 bags of Neonatal TPN Starter Bag due to lack of assurance of sterility and missing validation data for decontamination cycles.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 5% with CALCIUM and HEPARIN, total volume = 250mL, IV Bag, Rx Only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0415-1
    Category
    Drug
    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-0954-2023·2023-08-09

    EPINEPHrine IV bags recalled nationwide due to lack of sterility assurance

    Central Admixture Pharmacy Services is recalling 9,121 epinephrine IV bags distributed nationwide due to lack of sterility assurance and insufficient validation data for decontamination cycles.

    Product
    EPINEPHrine 4mg/250mL added to 0.9% sodium chloride, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-8093-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0949-2023·2023-08-09

    Succinylcholine Injectable Syringes Recalled for Unvalidated Decontamination Cycles

    Central Admixture Pharmacy Services recalls 26,208 succinylcholine injection syringes nationwide due to lack of validated sterilization procedures. The manufacturer lacks adequate validation data for decontamination cycles.

    Product
    succinylcholine 200 mg/10 mL (20 mg/mL), Syringe, Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue Pheonix, AZ, NDC 72196-6011-2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2324-2023·2023-08-09

    Medline Medical Procedural Kits Recalled for Potential Ultrasound Gel Sterility Failure

    Medline Industries recalls 19,907 procedural kits 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. CENTRAL LINE INSERT KIT W/O CA, Model Number: CVI3755; b. CENTRAL LINE KIT, Model Number: DYNDC2582, DYNDC2582A; c. CENTRAL LINE PACK-COMPANION, Model Num
    Category
    Medical Device
    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 (Food)·F-1335-2023·2023-08-09

    Sweetened Cranberries Recalled Due to Undeclared Allergen Cross Contamination

    Houston Pecan Company is recalling 5-pound bags of Sweetened Cranberries purchased before May 25, 2023. Product may contain undeclared tree nuts, peanuts, and wheat due to cross contamination. Distributed in Texas and via internet.

    Product
    Cranberries Sweetened packaged in 5 pound bags
    Category
    Food
    Distribution
    0 states