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.

12301–12325 of 27206

  • ModerateFDA (Drugs)·D-0367-2024·2024-03-13

    Mercaptopurine Tablets Recalled Due to Failed Dissolution Specifications

    Stason Pharmaceuticals recalls Mercaptopurine Tablets, USP 50 mg due to failed dissolution specifications at 9 months. Dissolution results were slightly below the required specification.

    Product
    Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076-913-02), b) 250-count bottle (NDC 69076-913-25), Rx only, Manufactured for: Quinn Pharmaceuticals, Boca Raton, FL, www.quinnrx.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0364-2024·2024-03-13

    Clindamycin Phosphate Topical Solution recalled for defective container leakage

    Contract Pharmaceuticals Limited Canada is recalling 45,875 bottles of Clindamycin Phosphate Topical Solution USP 1% due to defective containers that leak slowly. The product was distributed nationwide in the U.S. and Puerto Rico.

    Product
    Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, NDC 10135-0691-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1258-2024·2024-03-13

    Embrace Drill Tower Surgical Instruments Recalled Due to Mixed-Up Type Descriptions

    Waldemar Link recalled Embrace Drill Tower surgical instruments because type descriptions ("standard" vs "wedged") are mixed up in the product overview documentation. Surgeons may select incorrect instrument types due to the confusion.

    Product
    Embrace Drill Tower, Standard/Lateral (25mm)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1037-2024·2024-03-13

    Frios Gourmet Pops Fruity Pebbles popsicles recalled for undeclared Yellow #5

    Frios Gourmet Pops Fruity Pebbles Popsicles are being recalled due to undeclared Yellow #5 color additive. Consumers with sensitivity or allergy to tartrazine should not consume the product.

    Product
    Frios Gourmet Pops - Fruity Pebbles Popsicle 3oz frozen popsicle packaged individually in clear plastic sleeve. 48 popsicles per box. *Sold directly to end consumer via food truck
    Category
    Food
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-1248-2024·2024-03-13

    MRI Systems Show Incorrect Spatial Field Gradient Values

    Canon Medical's MRI systems display incorrect Spatial Field Gradient values that are lower than actual, which may cause discomfort for patients with MR-conditional implanted devices during scanning.

    Product
    MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0365-2024·2024-03-13

    Clindamycin Phosphate Topical Solution recalled due to defective container leakage

    Contract Pharmaceuticals Limited Canada is recalling Clindamycin Phosphate Topical Solution 1% due to defective containers with slow leakage. Lot 119874 (expires 06/30/2025) distributed nationwide in the U.S. and Puerto Rico is affected.

    Product
    Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, L5N 6R8, NDC 71428-0003-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1032-2024·2024-03-13

    Hazelnut type flavor product recalled for formula manufacturing deviation

    Synergy Flavors Inc is recalling NAT & ART HAZELNUT TYPE FLAVOR #521510 because the product was not manufactured in accordance with its formula specifications.

    Product
    NAT & ART HAZELNUT TYPE FLAVOR #521510, in 6 gallon and "275" tote
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Devices)·Z-1102-2024·2024-03-06

    Surgical kits and trays recalled due to lack of sterility

    Medline Industries is recalling over 3,200 surgical kits and trays containing components that may lack sterility. The recalled products could pose infection risk to patients if used during surgical procedures.

    Product
    MEDLINE Kits, trays, and packs labeled as follows: a) ASC GENERAL MINOR CDS, REF CDS983673G; b) ASC GENERAL MINOR CDS, REF CDS983673I; c) C NURSE BAG KIT, REF DYKM1425; d) DAILY DRIVELINE MGMT KIT w/PER, REF DT18700; e) GASTRIC CULTURE PACK, REF DYNJ53966A; f) GASTRI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1000-2024·2024-03-06

    ELV Alipotec tejocote supplement recalled due to toxic yellow oleander contamination

    World Green Nutrition's ELV Alipotec tejocote supplement contains toxic yellow oleander instead of the labeled ingredient. FDA Class I recall affects approximately 113,500 units.

    Product
    ELV ALIPOTEC brand MEXICAN TEJOCOTE ROOT SUPPLEMENT PIECES (RAIZ DE TEJOCOTE MEXICANO SUPLEMENTO EN TROZOS), NET. WT, 0.3 0Z (7g)
    Category
    Food
    Distribution
    8 states
  • CriticalFDA (Devices)·Z-1123-2024·2024-03-06

    Medline Surgical Kits Recalled for Potential Sterility Failure

    Medline Industries is recalling 533 units of gynecological laparoscopy kits and trays manufactured with Nurse Assist irrigation and saline components due to potential lack of sterility. The affected products were distributed nationwide in the U.S. and internationally.

    Product
    Medline Kits, trays, and packs labeled as follows: a) GYN LAPAROSCOPY, REF CDS984900M; b) GYN LAPAROSCOPY CDS, REF CDS983913S; c) GYN LAPAROSCOPY CDS, REF CDS983913T; d) GYN LAPAROSCOPY CDS, REF CDS983913U; e) GYN LAPAROSCOPY CDS, REF CDS983913V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1091-2024·2024-03-06

    Medline Tracheostomy Care Kits Recalled for Non-Sterile Component Solutions

    Medline Industries is recalling care and cleaning kits for tracheostomy and stomas due to component solutions that may not be sterile. The affected kits contain Nurse Assist-manufactured saline and irrigation solutions distributed in the U.S., Puerto Rico, Canada, UAE, and Panama.

    Product
    MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, labeled as: a) STOMA & TRACH CLEANING KIT, REF DYNDJ1129; b) TRACH CARE TRAY, REF DYNDJ1057A; c) TRACHEOSTOMY CARE KIT, REF DYNDA1893A; d) TRACH CARE TRAY, REF DYNDA1482
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1113-2024·2024-03-06

    Medline Medical Kits Recalled Due to Potential Lack of Sterility

    Medline is recalling approximately 3,900 medical device kits and trays nationwide due to potential sterility failures in irrigating solution components. The affected products may not be sterile, creating a risk of infection.

    Product
    Medline Kits, trays, and packs labeled as follows: a) PORT ACCESS TRAY, REF DYNDA2863; b) PORT ACCESS TRAY, REF DYNDA2863H; c) ULTRASOUND GUIDED IV START KIT, REF DYNDV2518; d) ULTRASOUND GUIDED IV START KIT, REF DYNDV2518H; e) KIT ULTRASOUND PIV START, REF DYNDV2445;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1007-2024·2024-03-06

    Ready Pac Bistro Queso Crunch Salad Kit recalled for Listeria contamination risk

    Ready Pac Bistro Queso Crunch Salad Kit (UPC 077745256139) is recalled due to potential Listeria monocytogenes contamination. Affected products have use-by dates between January 13 and February 18, 2024.

    Product
    Ready Pac Bistro Queso Crunch Salad Kit 24 oz. UPC 077745256139
    Category
    Food
    Distribution
    21 states
  • CriticalFDA (Devices)·Z-1120-2024·2024-03-06

    Medline wound care trays recalled due to sterility defect

    Medline Industries is recalling Wound Care Trays due to potential lack of sterility in solution components. The recall affects 72,624 units distributed nationwide and internationally.

    Product
    Medline Kits, trays, and packs labeled as follows: WOUND CARE TRAY - LATEX-FREE, REF DYND06002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1136-2024·2024-03-06

    Centurion LVAD Maintenance Kits Recalled for Potential Sterility Failure

    Medline Industries is recalling Centurion LVAD maintenance kits and driveline management trays due to sterility concerns in irrigation solution components from Nurse Assist. The solutions may be non-sterile and could pose infection risks.

    Product
    Centurion Kits, trays, and packs labeled as follows: a) A C DAILY WET KIT, REF DM405A; b) BWH DAILY DRIVELINE MGMT KIT, REF DM640; c) DAILY DRIVELINE MGMT SYSTEM, REF DM600; d) DAILY MAINTENANCE SYSTEM LVAD, REF DM870A; e) DAILY MAINTENANCE SYSTEM LVAD, REF DM870A; f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1011-2024·2024-03-06

    Sargento Fancy Shredded Swiss Cheese Recalled for Listeria Contamination

    Sargento Foods is recalling 1,143 cases of Fancy Shredded Swiss Cheese due to potential Listeria monocytogenes contamination. The affected products were distributed across 15 US states.

    Product
    Swiss cheese packaged in the following configurations: 1. Sargento Fancy Shredded Swiss Cheese, Pack Size 400/1 oz. Net Wt 25.000 lbs. Material #10000390, UPC 46100349816. 2. Sargento Fancy Shredded Swiss Cheese, Pack Size 500/0.5 oz. Net Wt 15.625 Material #100010
    Category
    Food
    Distribution
    15 states
  • CriticalFDA (Food)·F-1010-2024·2024-03-06

    Sargento Parmesan Cheese Products Recalled for Listeria Monocytogenes Contamination

    Sargento is recalling 1,791 cases of Parmesan cheese products distributed to 15 states due to potential Listeria monocytogenes contamination.

    Product
    Parmesan cheese packaged in the following configurations: 1. Sargento Fresh Grated Parmesan Cheese Pack Size 500/0.5 oz. Material #10000278, UPC 46100348659. 2. Sargento Part #10132 Fancy Shredded Parmesan Cheese Pack Size 500/0.5 oz. Material #10000284, UPC 4610033499
    Category
    Food
    Distribution
    15 states
  • CriticalFDA (Devices)·Z-1070-2024·2024-03-06

    VOCSN Pediatric breathing package spiral wrap detachment risk during ventilation

    Ventec Life Systems recalls VOCSN Patient Breathing Packages because the spiral wrap may detach during ventilation, compromising the breathing circuit and creating a risk of serious injury or death, especially for ventilator-dependent patients.

    Product
    VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001). Used with the VOCSN Unified Respiratory System which provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ven
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Food)·F-1009-2024·2024-03-06

    Sargento Cotija Cheese Products Recalled for Potential Listeria Contamination

    Sargento Foods is recalling specific Cotija cheese lots due to possible Listeria monocytogenes contamination. The recalled products were distributed across 15 U.S. states and consumers should discard or return them to retail.

    Product
    Cotija cheese packaged in the following configurations: 1. Sargento Course Grated Cotija Cheese Pack Size 6/5 lb. Material #10002578, UPC 46100352601. 2. Sargento Coarse Grated Cotija Cheese. Pack Size 500/0.5 oz. Net Wt. 15.625 lbs. Material #10003245, UPC 4610035517
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Food)·F-1006-2024·2024-03-06

    Ready Pac Bistro Fresh Mex Chopped Kit recalled for potential Listeria contamination

    Ready Pac Foods is recalling Ready Pac Bistro Fresh Mex Chopped Kit due to potential Listeria monocytogenes contamination. The recall affects 790 cases distributed across the United States.

    Product
    Ready Pac Bistro Fresh Mex Chopped Kit 10.5 oz. UPC 077745256108
    Category
    Food
    Distribution
    21 states
  • SevereFDA (Devices)·Z-1058-2024·2024-03-06

    AirLife Adult Manual Resuscitator tubing may fail to deliver proper ventilation

    Vyaire Medical is recalling 66,078 units of AirLife Adult Manual Resuscitator oxygen tubing worldwide due to component manufacturing defects that can cause device failure and inadequate ventilation.

    Product
    AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, without Mask, REF 2K8001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1096-2024·2024-03-06

    Medline Medical Kits Recalled for Potential Sterility Defect

    Medline Industries is recalling multiple surgical and critical care kits due to a potential lack of sterility in component solutions (sodium chloride irrigation, sterile water for irrigation, and saline flush syringes). Non-sterile solutions could expose patients to infection.

    Product
    MEDLINE Kits, trays, and packs labeled as follows: a) DIALYSIS FISTULA KIT, REF DYNDC3106, b) ENDO KIT, REF DYKE1346D, c) ENDO KIT, REF DYKE1892A, d) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648G, e) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I, f) FREQUENT DAILY VAD, REF DYN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1059-2024·2024-03-06

    AirLife Adult Manual Resuscitator recalled for faulty component causing ventilation failure

    Vyaire Medical is recalling 8,220 AirLife Adult Manual Resuscitators with defective duckbill and ring components. The manufacturing defect may prevent proper ventilation and could lead to hypoxia or death.

    Product
    AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1124-2024·2024-03-06

    Medline Surgical Kits Recalled Due to Sterility Defect in Irrigation Solutions

    Medline Industries recalls certain surgical kits and trays because irrigation solution components may lack sterility, creating potential infection risk.

    Product
    Medline Kits, trays, and packs labeled as follows: C-SECTION, REF DYNJ904653G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1111-2024·2024-03-06

    Medline Medical Device Kits Recalled for Potential Sterility Loss

    Medline Industries is recalling 26,171 kits and trays containing potentially non-sterile irrigation solutions and syringes supplied by Nurse Assist, which could pose risks if used in medical procedures.

    Product
    Medline Kits, trays, and packs labeled as follows: a) 709E RECOVERY PACK A,B,C II SS, REF DYNJ55960G; b) ABDOMEN PACK, REF DYNJ53643C; c) BAG TRUNK STOCK KIT, REF DYKM1880; d) BEDSIDE BRONCH PACK, REF DYKE1601; e) BIOPSY TRAY, REF DYNDH1242; f) BRONCH KIT, REF DYKE18
    Category
    Medical Device
    Distribution
    Distributed nationwide