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.

7501–7525 of 88183

  • ModerateFDA (Devices)·Z-2012-2025·2025-07-02

    Caphosol Artificial Saliva sachets recalled for out-of-specification stability

    Recordati Rare Diseases is recalling Caphosol Artificial Saliva 32-dose sachets because stability test results for Solution B were out of specification during process validation.

    Product
    Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0094-2025·2025-07-02

    Probese Caps dietary supplement recalled for undeclared food dyes

    Probese Caps, a dietary supplement with Iron sold in 90-count bottles, is being recalled because it contains undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No. 1) in the gelatin capsules.

    Product
    Probese Caps, dietary supplement with Iron. 90-count bottles. Legere Pharmaceuticals 15344 N 83rd way, Scottsdale AZ 85260 (Product does not have a UPC)
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·H-0061-2025·2025-07-02

    Windsor brand Extra Course Himalayan Pink Salt Grinder Refill recalled

    Windsor brand Extra Course Himalayan Pink Salt Grinder Refill is being recalled because the quantity of product in each unit does not match the stated weight on the packaging.

    Product
    Windsor brand Extra Course Himalayan Pink Salt Grinder Refill, 255 g, packaged in a glass jar with plastic cap and packed 6 units per case, each unit sold individually; Imported by Windsor Salt Ltd., Pointe-Claire, Quebec H9R 5M9
    Category
    Food
    Distribution
    0 states
  • LowFDA (Food)·H-0062-2025·2025-07-02

    Windsor Brand Extra Coarse Sea Salt Grinder Refill Weight Mismatch

    Windsor brand Extra Coarse Sea Salt Grinder Refill (255 g) does not contain the stated weight of product in each unit. Morton Salt Inc. is recalling 28,820 units distributed in Canada.

    Product
    Windsor brand Extra Course Sea Salt Grinder Refill, 255 g, packaged in a glass jar with plastic lid and packed 6 units per case, each unit sold individually; Imported by Windsor Salt Ltd., Pointe-Claire, Quebec H9R 5M9
    Category
    Food
    Distribution
    0 states
  • LowFDA (Food)·H-0095-2025·2025-07-02

    NutriLean Dietary Supplement Contains Undeclared Food Dyes

    Preventics, Inc. dba Legere Pharmaceuticals is recalling NutriLean dietary supplements nationwide because the gelatin capsules contain undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No. 1) food dyes, which are not listed on the label.

    Product
    NutriLean, dietary supplement. Legere Pharmaceuticals 15344 N 83rd way, Scottsdale AZ 85260 (Product does not have a UPC)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·H-0096-2025·2025-07-02

    Rodex Forte dietary supplement recalled for undeclared food dyes

    Rodex Forte dietary supplement (90-capsule bottles) is being recalled because the gelatin capsules contain undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No. 1), which are not listed on the label.

    Product
    Rodex Forte, dietary supplement. 90 capsule bottles. Legere Pharmaceuticals 15344 N 83rd way, Scottsdale AZ 85260 (Product does not have a UPC)
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1946-2025·2025-06-25

    Dexcom One Continuous Glucose Monitoring System Receiver Speaker Defect

    Dexcom, Inc. is recalling Dexcom One Continuous Glucose Monitoring System receivers due to potential defective foam or assembly errors that may cause the speaker to lose contact with internal components, resulting in missed audible alerts for dangerous blood glucose levels.

    Product
    Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1), STK-DO-013 (MT27409-1), STK-DO-103 (MT27409-2), STK-DO-109 (MT27409-2)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1945-2025·2025-06-25

    Dexcom One+ Continuous Glucose Monitoring System Receiver Speaker Defect

    Dexcom, Inc. is recalling 26,291 units of the Dexcom One+ Continuous Glucose Monitoring System due to defective foam or assembly errors that may prevent audible alerts for low or high blood glucose levels, potentially leading to seizures, loss of consciousness, or death.

    Product
    Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (MT28285-1), STK-D7-014 (MT28285-1), STK-D7-103 (MT28285-2)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1944-2025·2025-06-25

    Dexcom G7 Glucose Receiver recalled due to defective foam or assembly error

    Dexcom, Inc. is recalling Dexcom G7 Glucose Receiver units due to defective foam or assembly error that may cause the speaker to lose contact with the circuit board, preventing audible alerts for low or high blood glucose.

    Product
    Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-AT-012 (MT26403-0), STK-AT-013 (MT26403-0), STK-GT-001 (MT26403-1), STK-GT-008 (MT26403-5), STK-GT-013 (MT26403-1) , STK-GT-019 (MT26403-4) , STK-GT-100 (MT26403-2), STK-GT-109 (MT26403-2) , STK-GT-113…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0492-2025·2025-06-25

    UNAVY ACIDO HIALURONICO supplement recalled for undeclared pharmaceutical ingredients

    UNAVY ACIDO HIALURONICO hyaluronic acid supplement is being recalled because it contains three undeclared pharmaceutical ingredients: Dexamethasone, Diclofenac, and Omeprazole. The product was marketed without FDA approval and poses health risks from the unlisted drugs.

    Product
    UNAVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7 503046 054295
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0938-2025·2025-06-25

    Afghani Corn Bread Doda Recalled for Undeclared Wheat and Sesame

    Ariana Sweets Inc. is recalling Afghani Corn Bread "Doda" because the product contains undeclared wheat and sesame allergens, which are not listed on the label.

    Product
    AFGHANI CORN BREAD "Doda"; INGREDIENTS: Corn Flour, Sugar, Vegetable Oil, Eggs, Milk, Black Seeds, Caardamom; ALLERGEN STATEMENT: This product contains eggs, milk, and may contain traces of nuts. NET WT 24.0 oz (680g); Keep Cool. Reheat in oven if desired.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1943-2025·2025-06-25

    Dexcom G6 Glucose Receiver recalled for missed audible alerts

    Dexcom G6 Glucose Receiver units may have defective foam or assembly errors that disable audible alerts for dangerously low or high blood glucose, risking seizures, loss of consciousness, or death.

    Product
    Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0055-2025·2025-06-25

    Fruit and Veg Tray 64oz Recalled for Potential Salmonella Contamination

    GBC Food Services, LLC is recalling Fruit and Veg Tray 64oz products due to potential Salmonella contamination. The affected products were distributed to multiple states and purchased between May 8 and May 21, 2025.

    Product
    Fruit and Veg Tray 64oz 850065403748 Purchase Dates: 05/08/2025 to 05/21/2025
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·H-0052-2025·2025-06-25

    Cucumber bowls and snack cups recalled due to Salmonella contamination risk

    GBC Food Services, LLC is recalling cucumber products sold between May 8 and May 21, 2025, due to potential Salmonella contamination. Affected products include Cucumber Bowl with Ranch dip, Cucumber Slices with Tajin, and Cucumber with Ranch Snack Cup.

    Product
    Cucumber Bowl with Ranch dip 15oz UPC 850054894519 Purchase Dates: 05/08/2025 to 05/21/2025 Cucumber Slices W/Tajin 10 oz UPC 85005368569 Purchase Dates: 05/08/2025 to 05/21/2025 Cucumber w/ Ranch Snack Cup 9.5 oz UPC 850065403144 Purchase Dates: 05/08/2025 to…
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·H-0054-2025·2025-06-25

    Ready-to-eat salads recalled for potential Salmonella contamination

    GBC Food Services is recalling multiple ready-to-eat salad products due to potential Salmonella contamination. The affected salads were purchased between May 8 and May 21, 2025.

    Product
    Chef Salad 11oz 850065403328 Purchase Dates: 05/08/2025 to 05/21/2025 Family Cobb Salad 22OZ 850054894625 Purchase Dates: 05/08/2025 to 05/21/2025 Individual Garden Salad 12OZ 850054894618 Purchase Dates: 05/08/2025 to 05/21/2025 Individual Greek Salad 12OZ 850054894649 Purchase…
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Devices)·Z-1902-2025·2025-06-25

    Cook Beacon Tip Angiographic Catheters Recalled for Tip Separation Risk

    Cook Incorporated is recalling specific lots of Beacon Tip 5.0 Fr Angiographic catheters due to the risk that the catheter tip may separate during use. The affected catheters were distributed worldwide.

    Product
    Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are available in various configurations. Configurations include different shaft lengths and tip curves and some catheters are manufactured with a hydrophilic…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0493-2025·2025-06-25

    UMOVY ACIDO HIALURONICO supplement recalled for undeclared prescription drugs

    UMOVY ACIDO HIALURONICO dietary supplement has been recalled because it contains undeclared prescription ingredients Dexamethasone and Diclofenac. The product was marketed without FDA approval.

    Product
    UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7503046054134
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0056-2025·2025-06-25

    Cucumber Carrot Ranch Pack 20oz recalled for Salmonella contamination

    GBC Food Services is recalling Cucumber Carrot Ranch Pack 20oz due to potential Salmonella contamination. The affected products were purchased between May 8 and May 21, 2025, and distributed across nine states.

    Product
    Cucumber Carrot Ranch Pack 20oz 850065403557 Purchase Dates: 05/08/2025 to 05/21/2025
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·H-0057-2025·2025-06-25

    Ginger Beer Juice Soda Recalled for Potential Salmonella Contamination

    RGB Soda, LLC is recalling Refrigerated Cucumber X Tarragon Ginger Beer distributed in Washington due to potential Salmonella contamination. The affected batches were produced on 11/4/2024 and 11/25/2024.

    Product
    Refrigerated Cucumber X Tarragon Ginger Beer (ginger juice). Product is juice soda and distributed in 5gal. pony keg. The kegs were distributed to the firm's own stores where they were served to glasses. The kegs were labeled with the name of the product and the day it was made.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·H-0046-2025·2025-06-25

    Lancaster LF Authentic Greek Salad Kit Recalled for Salmonella Risk

    Reser's Fine Foods is recalling Lancaster LF Authentic Greek Salad Kits distributed in MA and PA because the cucumbers may be contaminated with Salmonella. The kits are implicated in an ongoing Salmonella outbreak.

    Product
    Lancaster LF Authentic Greek Salad Kit, 2/7.125lb. packages, net wt. 14.25lb., Item Code 407079, UPC 13454.38482. This is wholesale kit consisting of pre-packaged components in a corrugated box for assembly by retail delis. Kit contains sealed bags of cut produce (sliced…
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·H-0045-2025·2025-06-25

    Big Y Deli Sandwiches Recalled for Salmonella-Contaminated Cucumber

    Big Y Supermarkets has recalled various made-to-order deli sandwiches because cucumbers used in the products were contaminated with Salmonella. The recall affects sandwiches sold on May 20 and 21 at Big Y locations in Massachusetts and Connecticut.

    Product
    Big Y various sandwiches made to order at deli counter (Subs (small, large, supersub), wrap, panini, grinders); UPC Codes: 22172700000, 22178100000, 22247700000, 22314200000, 22314300000, 22314400000, 22314500000, 22314600000, 22314700000, 22314800000, 22314900000, 22315000000…
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·H-0053-2025·2025-06-25

    Vegetable Bowls and Trays Recalled for Potential Salmonella Contamination

    GBC Food Services is recalling vegetable bowls and vegetable ranch trays due to potential Salmonella contamination. Affected products were purchased between May 8 and May 21, 2025.

    Product
    Vegetable Bowl $5 13oz 850065403380 Purchase Dates: 05/08/2025 to 05/21/2025 Vegetable Bowl $10 26 oz 860010507131 Purchase Dates: 05/08/2025 to 05/21/2025 Vegetable Ranch Tray No Dip Small 19.50 oz 850054894335 Purchase Dates: 05/08/2025 to 05/21/2025 Large Vegetable Tray…
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-1985-2025·2025-06-25

    Surgical Mesh Recalled for Potential Residual Adhesive Material

    Chamberlain Technologies LLC is recalling SURGIMESH XB surgical mesh due to potential residual adhesive material on the mesh surface. The affected product was distributed to Illinois, Nebraska, and California.

    Product
    SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Catalog Number: Tintra E-3030
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1991-2025·2025-06-25

    ICU Medical Plum Solos Infusion Pump Software Safety Defect Recall

    ICU Medical is recalling Plum Solos infusion pumps (Item 400011001) with software version 1.1.1 due to a workflow that may bypass the Maximum Dose Limit alert, which is designed to prevent overdose. The defect affects 214 units distributed across nine US states and the Philippines.

    Product
    ICU Medical Plum Solos, Item number 400011001; infusion pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1980-2025·2025-06-25

    Portable Oxygen Concentrator with Erroneous Calibration Values

    Ohio Medical Corporation is recalling 36 units of the GCE HEALTHCARE Zen-O lite portable oxygen concentrator due to erroneous calibration values that may cause the device's alarm for low oxygen purity to function incorrectly as the device ages.

    Product
    GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
    Category
    Medical Device
    Distribution
    Distributed nationwide