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.

8176–8200 of 88183

  • ModerateFDA (Drugs)·D-0393-2025·2025-05-07

    Wegovy injection recalled due to temperature exposure during shipping

    Cardinal Health is recalling Wegovy (semaglutide) 2.4 mg injection due to temperature abuse during shipping. Product was removed from refrigerated storage for an extended period due to a distribution center error.

    Product
    Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx Only, Single-Dose Only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, DK-2880, Bagsvaerd, Denmark, NDC 0169-4524-14.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1705-2025·2025-05-07

    Medline Sterile Water USP bottles recalled for leaking at peel-foil interface

    Medline Sterile Water, USP 100mL bottles are being recalled because they leak at the interface between the peel-foil and bottle opening, posing a contamination risk.

    Product
    Medline Sterile Water, USP, 100mL, REF RDI30295
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1709-2025·2025-05-07

    Medline Sterile Water and Saline Bottles Recalled for Leaking Seals

    Medline Industries is recalling Sterile Water and Sterile 0.9% Normal Saline bottles due to leaking at the peel-foil and bottle opening interface. The affected kits were distributed nationwide and internationally.

    Product
    Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2) STRL EK SINGLE PACK, REF DYNDA1360B; 3) SHEATH REMOVAL TRAY, REF DYNDC1311C; 4) SENSITIVE SKIN WEEKLY VAD, REF DYNDC3185; 5) NURSING SKILLS, REF EDUC05015A; 6) NURSING SUPPLY BAG, REF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1706-2025·2025-05-07

    Medline Sterile 0.9% Normal Saline 100mL bottles recalled for leaks

    Medline Sterile 0.9% Normal Saline 100mL bottles are being recalled because they may leak at the interface where the peel-foil meets the bottle opening. The bottles were distributed nationwide in the US and in Panama and Canada.

    Product
    Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0746-2025·2025-05-07

    Chile Verde Egg Bites recalled for potential foreign material contamination

    Valley Fine Foods Co., Inc is recalling Chile Verde Egg Bites due to potential contamination with foreign materials. Affected products were distributed in Texas.

    Product
    CHILE VERDE EGG BITES; NET WT. 4.6 OZ (130 g); 2 egg bites/package
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1693-2025·2025-05-07

    Automated External Defibrillator Model DDU-2450 Missing Italian Translation

    Defibtech, LLC is recalling one Automated External Defibrillator Model DDU-2450 (German language version) distributed in Switzerland because it lacks required Italian language labeling and instructions for use.

    Product
    Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1712-2025·2025-05-07

    Medline Sterile Water and Saline Bottles Recalled for Leaking Peel-Foil Seals

    Medline procedure kits containing Sterile Water and Sterile 0.9% Normal Saline bottles are being recalled because the bottles leak at the peel-foil and bottle opening interface.

    Product
    Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1694-2025·2025-05-07

    Defibtech Automated External Defibrillators Model DDU-2200 Missing Italian Translation

    Defibtech is recalling Automated External Defibrillators Model DDU-2200 distributed in Switzerland due to missing Italian translation of product labeling and instructions, which violates Swiss Medical Devices Ordinance requirements.

    Product
    Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual language)
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1690-2025·2025-05-07

    Semi-Automated External Defibrillators Missing Italian Language Labeling

    Defibtech is recalling semi-automated external defibrillators (Models DDU-100 and DDU-100E) distributed in Switzerland because they lack required Italian language labeling and instructions for use.

    Product
    Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), DCF-E110SG-FR/1 (French language), DCF-E110SG-IT/1 (Italian language)
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1691-2025·2025-05-07

    Automated External Defibrillators DDU-2200 Missing Italian Language Translation

    Defibtech is recalling Automated External Defibrillators Model DDU-2200 distributed in Switzerland because they lack required Italian language labeling and instructions for use.

    Product
    Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual language)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0730-2025·2025-04-30

    Walker's Wine Juice Pumpkin Juice recalled for potential botulinum contamination

    Walker's Wine Juice Pumpkin Juice in 2.5, 5, 30, 60, and 275 gallon bulk containers is being recalled due to potential contamination with Clostridium botulinum. The product was distributed across multiple states.

    Product
    Walker's Wine Juice Pumpkin Juice 2.5, 5, 30, 60, 275 gallon bulk containers
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Food)·F-0732-2025·2025-04-30

    MO-CHA Premium Non-Dairy Creamer Recalled for Undeclared Milk Allergen

    MO-CHA brand Premium Non-Dairy Creamer is recalled because the label does not declare milk as an allergen, despite milk being present in the product. Consumers with milk allergies are at risk of adverse reaction.

    Product
    MO-CHA brand Premium Non-Dairy Creamer; INGREDIENTS Glucose syrup, Refined vegetable oil, Whey powder, Sugar, Casein, Emulsifier (471, 481i), Stabilizer(340ii, 452i), Anti-caking agent(551), Food flavor; Shelf Life: 24 months; Net Weight (NET WT): 2.2 lbs (1kg); IMPORTED BY Momo…
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1644-2025·2025-04-30

    Amplatzer TorqVue LP Catheter Recalled for Shaft Breach Risk

    Abbott is recalling the Amplatzer TorqVue LP Catheter (Model 9-TVLPC4F90/080) due to a potential small breach in the proximal shaft that may not be visible and could lead to prolonged procedures, blood loss, or air embolism.

    Product
    Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0722-2025·2025-04-30

    Zaarah Herbals Gurmar Powder recalled for elevated lead levels

    Zaarah Herbals brand Gurmar Powder is being recalled due to elevated lead levels. The product was distributed in New York, Connecticut, New Jersey, and California.

    Product
    Zaarah Herbals brand Gurmar Powder; packaged in 100g clear jars with gold lids; UPC: 6 35028 99969 4
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0724-2025·2025-04-30

    Zaarah Herbals Rasayan Churan Recalled for Elevated Lead Levels

    Zaarah Herbals brand Rasayan Churan (100g jars) is recalled due to elevated lead levels of 88.038 ppm. The product was distributed in New York, Connecticut, New Jersey, and California.

    Product
    Zaarah Herbals brand Rasayan Churan; packaged in 100g clear jars with gold lids; UPC:6 35028 99966 3
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0372-2025·2025-04-30

    PHENYLephrine HCl Injection Syringes Recalled for Lack of Sterility

    Denver Solutions, LLC DBA Leiters Health is recalling PHENYLephrine HCl 0.5 mg per 5mL single-dose syringes because some syringes may be leaking or damaged, which could compromise sterility assurance.

    Product
    PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-001-11,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0374-2025·2025-04-30

    Rocuronium Bromide Syringes Recalled Due to Sterility Assurance Risk

    Denver Solutions, LLC DBA Leiters Health is recalling Rocuronium Bromide 50 mg per 5mL syringes due to potential leaking or damage that may compromise sterility assurance.

    Product
    Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-004-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0369-2025·2025-04-30

    Haloperidol Decanoate Injection Recalled Due to Sterility Concerns

    Amerisource Health Services LLC is recalling Haloperidol Decanoate Injection vials nationwide because some media fill units showed bacterial contamination, indicating a lack of sterility assurance. The affected product is a 100mg/mL injectable antipsychotic medication.

    Product
    HALOPERIDOL DECANOATE — HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0721-2025·2025-04-30

    Zaarah Herbals Bhringraj Powder Recalled for Elevated Lead and Arsenic

    Zaarah Herbals brand Bhringraj Powder contains elevated levels of lead and arsenic. Consumers should not use the product and should contact the recalling firm for instructions.

    Product
    Zaarah Herbals brand Bhringraj Powder; packaged in 100g clear jars with gold lids; UPC: 6 35028 99973 1
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0371-2025·2025-04-30

    Dexmedetomidine HCl Syringes Recalled for Potential Sterility Issue

    Leiters Health is recalling dexmedetomidine HCl PF syringes nationwide due to leaking or damaged syringes that may not maintain sterility. Affected lot 2431276A has an expiration date of 4/20/2025.

    Product
    dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112, NDC: 71449-131-11.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1585-2025·2025-04-30

    Novasight Hybrid Catheter Recalled for Potential Sheath Detachment

    Conavi Medical Inc. is recalling the Novasight Hybrid Catheter (Model TA-06-0001) due to manufacturing issues that could cause the catheter sheath to detach. The device is used for diagnostic intravascular imaging.

    Product
    Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common Name: Diagnostic intravascular catheter Description: The Novasight Hybrid catheter is a 3Fr single use, sterile device, which will be able…
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Food)·F-0720-2025·2025-04-30

    Chicken Salad Recalled Due to Undeclared Milk Allergen

    Cromer Food Services is recalling chicken salad sandwiches because milk was not declared on the label. Consumers with milk allergies are at risk.

    Product
    CFS CROMER FOOD SERVICES, INC. Anderson, SC 29621 CHICKEN SALAD On White NET WT. 4.3 OZ CONTAINS: EGGS, WHEAT, SOY UPC 31166 & UPC 13172
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0368-2025·2025-04-30

    Haloperidol Decanoate Injection Recalled for Lack of Sterility Assurance

    Amerisource Health Services LLC is recalling Haloperidol Decanoate Injection due to lack of assurance of sterility and bacterial contamination detected in some media fill units. The affected product was distributed nationwide.

    Product
    HALOPERIDOL DECANOATE — HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0367-2025·2025-04-30

    Haloperidol Decanoate Injection Recalled Due to Sterility Concerns

    Amerisource Health Services LLC is recalling Haloperidol Decanoate Injection due to lack of assurance of sterility and bacterial contamination detected in some media fill units. The drug is used for intramuscular injection to treat psychiatric conditions.

    Product
    HALOPERIDOL DECANOATE — HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0373-2025·2025-04-30

    Ketamine HCl Syringes Recalled for Lack of Sterility Assurance

    Denver Solutions, LLC is recalling Ketamine HCl 50mg per 5mL single-dose syringes nationwide due to leaking or damaged syringes that may lack sterility assurance. Two affected lots are identified with expiration dates in July 2025.

    Product
    Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11
    Category
    Drug
    Distribution
    Distributed nationwide