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.

15601–15625 of 27263

  • HighFDA (Drugs)·D-1014-2023·2023-08-09

    Neonatal TPN Starter Bags recalled due to sterility assurance failure

    Central Admixture Pharmacy Services is recalling 80 Neonatal TPN Starter Bags due to lack of sterile assurance. Decontamination cycle validation data was not available, creating a potential contamination risk.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 6%/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: 72196-0423-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2299-2023·2023-08-09

    Medline Procedural Kits Recalled for Ultrasound Gel Sterility Defect

    Medline Industries recalls 104,755 procedural kits due to potential sterility defect in ultrasound gel component. No illnesses or injuries have been reported.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. MULTI-LUMEN CVC BUNDLE KIT, Model Number: ECVC475; b. MULTI-LUMEN CVC INSERTION BUNDLE, Model Number: ECVC3900; c. MULTIMED 16G 1L 20CM CVC STOCK+BUNDLE US, Mode
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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 (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 (Devices)·Z-2317-2023·2023-08-09

    Medline Procedural Kits Recalled for Ultrasound Gel Sterility Defect

    Medline Industries recalled 11,436 procedural kits with Turkuaz ultrasound gel that may not meet sterility specifications. The affected kits were distributed worldwide from April 2020 to April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. (54) KIT STC PLASTIC FREE FLAP, Model Number: DYNJ909031; b. BREAST, Model Number: DYNJ904598B; c. BREAST DBL PROCED SUPPLEMENT, Model Number: DYNJ63893;
    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 (Drugs)·D-1056-2023·2023-08-09

    Succinylcholine Injectable Syringes Recalled for Sterility Validation Deficiency

    Central Admixture Pharmacy Services Inc recalls 12,239 succinylcholine injection syringes (200 mg/10 mL) distributed nationwide due to lack of validation data for sanitization cycles.

    Product
    succinylcholine, 200 mg/10 mL, (20 mg/mL), 10 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6011-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2326-2023·2023-08-09

    FDA Recalls Medline Procedural Kits Due to Potential Sterility Failure

    Medline Industries is recalling 22 procedural kits because the included ultrasound gel may not be sterile as labeled. The kits were distributed worldwide.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PREMIUM CLOSUREPLUS PACK, Model Number: DYNJ54326A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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-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 (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 (Food)·F-1362-2023·2023-08-09

    BelVita Breakfast Sandwich recalled for undeclared peanut allergen

    Mondelez is recalling belVita Breakfast Sandwich Dark Chocolate Creme and Cinnamon Brown Sugar varieties due to undeclared peanut allergen. The affected products were distributed to all 50 states.

    Product
    belVita Breakfast Sandwich, Dark Chocolate Creme variety (8 - 14.08 oz packages)
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2252-2023·2023-08-09

    Fusion Lithotripsy Extraction Baskets recalled for mechanical defects

    Wilson-Cook Medical's Fusion Lithotripsy Extraction Baskets are being recalled due to mechanical defects that can prevent the basket from advancing or retracting, or cause the drive wire to break or separate during use.

    Product
    Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic removal of biliary stones and foreign bodies.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-1047-2023·2023-08-09

    Fentanyl Injectable Syringes Recalled Due to Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling 1,216 fentanyl 2500 mcg/50 mL syringes distributed nationwide due to lack of validation data for sanitization cycles, which cannot assure sterility.

    Product
    fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-3
    Category
    Drug
    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 (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 (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 (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-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 (Drugs)·D-0948-2023·2023-08-09

    Vancomycin IV Bags Recalled Nationwide for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 3,980 IV vancomycin bags nationwide. The decontamination process was not properly validated, raising sterility concerns. No illnesses reported.

    Product
    vancomycin 1 g/250 mL added to 0.9% sodium chloride, 4 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6064-1
    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 (Drugs)·D-0951-2023·2023-08-09

    FDA recalls dilTIAZem IV bags due to sterility assurance concerns

    Central Admixture Pharmacy Services is recalling 2,260 dilTIAZem IV bags nationwide because validation data for the decontamination process is lacking. Affected lots expire between July and August 2023.

    Product
    dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6054-1
    Category
    Drug
    Distribution
    Distributed nationwide