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.

7826–7850 of 27089

  • HighFDA (Devices)·Z-0810-2025·2025-01-15

    Xhibit Telemetry Receiver software versions may cause unsolicited system shutdowns

    Telemetry receivers with affected software versions may unexpectedly shut down for 1-1.5 minutes, temporarily disabling patient monitoring. This could delay clinical response if a patient event occurs during the outage.

    Product
    Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Drugs)·D-0189-2025·2025-01-15

    Duloxetine Delayed-Release Capsules Recalled for Manufacturing Impurity Above Safe Limits

    Rising Pharma is recalling 73,680 bottles of Duloxetine 20 mg capsules nationwide due to N-nitroso-duloxetine impurity above recommended limits from manufacturing deviations. No illnesses have been reported.

    Product
    Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0381-2025·2025-01-15

    Chow Ciao Breaded Broccoli Nuggets Recalled for Metal Contamination

    Better Brands Inc. recalls Chow Ciao Whole Grain Breaded Broccoli Nuggets due to metal contamination. Lot 24241 from 08/27/2024 affects 168 cases.

    Product
    Chow Ciao Whole Grain Breaded Broccoli Nuggets - 30 lbs.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0815-2025·2025-01-15

    Tec 820 ISO Anesthesia Vaporizers can deliver less anesthetic than dial setting

    GE Medical Systems is recalling 644 Tec 820 ISO Anesthesia Vaporizers due to a manufacturing issue that causes them to deliver less anesthetic than the dial setting indicates. Distributed nationwide and globally.

    Product
    Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0191-2025·2025-01-15

    FDA Recalls Radiopharmaceutical Kit Due to Failed Stability Specifications

    Jubilant Draximage is recalling 5,209 kits of Technetium Tc 99m Sulfur Colloid Injection that failed stability specifications. The affected lots (C2300070, C2300070E) were distributed nationwide.

    Product
    Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx Only, Manufactured for: Jubilant Draximage Inc., dba Jubilant Radiopharma, Kirkland , Quebec, H9H, 4J$, Canada, NDC# 65174-179-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0184-2025·2025-01-15

    Clobazam Tablets Recalled for Foreign Tablet Contamination

    Amerisource Health Services LLC is recalling Clobazam 10 mg tablets due to the presence of foreign tablets or capsules in some packages. The recall affects 5,178 cartons with Lot #1019594 distributed nationwide.

    Product
    CLOBAZAM — CLOBAZAM (CLOBAZAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0808-2025·2025-01-15

    Aerin Medical VivAer Stylus Recall: Programming Error Causes Device Misidentification

    Aerin Medical is recalling 479 units of VivAer Stylus (Lot #10235) due to incorrect programming in units from a single lot. When connected to the Aerin Console, affected devices will be incorrectly identified as RhinAer Stylus.

    Product
    Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0814-2025·2025-01-15

    Anesthesia Vaporizers May Deliver Less Anesthetic Than Dial Setting Due to Manufacturing Defect

    Certain Tec 6 Plus and Tec 800 series anesthesia vaporizers may deliver less anesthetic agent than the dial setting indicates due to a manufacturing issue. Approximately 1,573 units are affected, distributed in the United States and globally.

    Product
    Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9610-000, 1107-9612-000, 1107-9616-000, 1107-9617-000, 2066835-001, 2069767-001, 2078800-001, 2091008-001, 2091009-001, M1098876, M1145610, M1220023, M1220854, M122
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0382-2025·2025-01-15

    Connie's Classic Thin Crust Cheese Pizza Recalled for Plastic Contamination

    Palermo Villa, Inc is recalling Connie's Classic Thin Crust Cheese Pizza due to the presence of plastic in the product. The affected frozen pizzas were distributed in Illinois, Minnesota, and Wisconsin.

    Product
    Connie's Classic Thin Crust Cheese Pizza, Chicago's Finest. Net Wt 20.36 oz. (1lb 4.36 oz) 577g. UPC 0 75706-19104 8. Keep Refrigerated. Distributed by: Palermo Villa, nc. Milwaukee, WI 53208.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0809-2025·2025-01-15

    Xhibit Telemetry Receiver may shut down, causing temporary loss of patient monitoring

    Spacelabs Healthcare's Xhibit Telemetry Receiver (Model 96280) may experience a Windows proxy issue causing the system to restart and go offline for 1-1.5 minutes, creating a temporary gap in patient monitoring.

    Product
    Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-0803-2025·2025-01-15

    Beckman Coulter PTH Assay Reagent Packs Recalled for Filling Defects

    Beckman Coulter is recalling Access PTH assay reagent packs from lot 339071 due to under- or over-filling in well 0, which could cause sealing issues, contamination, and inaccurate test results.

    Product
    Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems, Catalog Number A16972
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0185-2025·2025-01-15

    Medroxyprogesterone Acetate Injectable Suspension Recalled for Manufacturing Deviations

    Eugia US LLC is recalling medroxyprogesterone acetate injectable suspension (150mg/mL) due to manufacturing practice deviations. This voluntary recall affects 19,872 vials distributed nationwide.

    Product
    MEDROXYPROGESTERONE ACETATE — MEDROXYPROGESTERONE ACETATE (MEDROXYPROGESTERONE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0190-2025·2025-01-15

    Duloxetine Drug Recall Due to Manufacturing Impurity Levels

    Rising Pharma recalls Duloxetine DR Capsules 60 mg nationwide due to N-nitroso-duloxetine impurity levels exceeding FDA limits. Affected batches were distributed nationwide; check lot numbers on bottle labels for affected product.

    Product
    Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0813-2025·2025-01-15

    Medical radiographic system arm drop hazard due to missing safety bolts

    GE Healthcare Optima XR240amx systems with column replacement may have missing bolts in the Column Safety mechanism. If these bolts are missing and the counterpoise cable fails, the X-ray arm could drop.

    Product
    GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-27; 2) 5555000-31; 3) 5555000-33; 4) 5555000-41; 5) 5555000-47; 6) A0700DL; 7) A1700DA; 8) To be provided.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0807-2025·2025-01-15

    Neptune Medical Suction Rovers Recalled Due to Loose Bolts

    Stryker's Neptune 3 and Neptune S Rover surgical suction systems are recalled due to improperly tightened bolts on the vacuum pump filter housing. Loose bolts may cause loss of suction force during medical procedures.

    Product
    100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V NEPTUNE 3 ROVER ENGLISH (0703-002-000ENG) 230V NEPTUNE 3 ROVER SPANISH (0703-002-000ES)
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0802-2025·2025-01-15

    VACUETTE SAFELINK Blood Collection Holder May Leak Due to Defective Sleeve

    Greiner Bio-One GmbH is recalling VACUETTE SAFELINK blood collection holders because the protective rubber sleeve may bunch up and fail to retract, causing potential blood leakage from the device.

    Product
    VACUETTE SAFELINK, REF: 450210
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0816-2025·2025-01-15

    Tec 820 SEV Anesthesia Vaporizer Recalled for Inadequate Anesthetic Delivery

    GE Medical Systems is recalling approximately 928 Tec 820 SEV anesthesia vaporizers due to a manufacturing defect that can cause them to deliver less anesthetic agent than the dial setting indicates. The devices are distributed nationwide and globally.

    Product
    Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0186-2025·2025-01-15

    Progesterone Injection Recalled Nationwide for Glass Particulate Matter

    Eugia US LLC is recalling Progesterone Injection due to a market complaint of glass particles found in vials. The affected batch poses a potential risk to patients who receive injections from contaminated vials.

    Product
    PROGESTERONE — PROGESTERONE (PROGESTERONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0188-2025·2025-01-15

    Duloxetine Delayed-Release Capsules recalled for manufacturing deviation and impurity

    Rising Pharma is recalling certain batches of Duloxetine Delayed-Release Capsules 30 mg due to a manufacturing deviation that resulted in elevated N-nitroso-duloxetine impurity above FDA's recommended interim limit.

    Product
    Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0392-2025·2025-01-15

    Wellsley Farm Greek Yogurt recalled for possible plastic contamination

    HP Hood is recalling Wellsley Farm Plain Non-Fat Greek Yogurt (40 oz) because some containers may contain plastic foreign objects. The affected product was distributed in Maryland, Connecticut, and Kentucky.

    Product
    WELLSLEY FARM PLAIN NON-FAT GREEK YOGURT; 40 oz; UPC 888670048085
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-0192-2025·2025-01-15

    Metformin ER 500 mg tablets recalled due to foreign tablet contamination

    Granules Pharmaceuticals is recalling Metformin ER 500 mg tablets due to discovery of a Paracetamol tablet in one bottle. Patients taking the affected lot should verify their medication with their pharmacy.

    Product
    METFORMIN ER 500 MG — METFORMIN ER 500 MG (METFORMIN ER 500 MG)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0819-2025·2025-01-15

    AMT Mini Enteral Extension Set Recalled for Incorrect Connector Type

    Applied Medical Technology is recalling AMT Mini Enteral Extension Sets due to incorrect ENFit connector type. Affected units have ENFit connections instead of non-ENFit, preventing proper compatibility with intended systems.

    Product
    AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Food)·F-0407-2025·2025-01-15

    Great Value Chicken Broth Recalled Due to Potential Packaging Failures

    Tree House Foods is recalling 2,023 cases of Great Value Chicken Broth due to potential packaging failures that could compromise sterility and cause spoilage. The product was distributed to AL and AR.

    Product
    Great Value, Chicken Broth, 48 oz. , Aseptic paper cartons, 6 retail units per case, 120 cases/pallet .
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0805-2025·2025-01-15

    Diagnostic Immunoassay Kits Recalled for Incorrect Expiration Date Labeling

    Qualigen is recalling 426 units of FastPack SHBG diagnostic kits due to incorrect expiration date labels on three lots. The kits were distributed to 15 U.S. states.

    Product
    The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in human serum and plasma. For in vitro diagnostic Use and contains 30 FastPacks.
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Drugs)·D-0183-2025·2025-01-15

    Methadone Hydrochloride Tablets recalled for illegible product identification

    West-Ward Columbus is recalling Methadone Hydrochloride Tablets, 5mg, in unit-dose packaging due to illegible product identification on individual tablets. Lot AC2556A was distributed nationwide.

    Product
    METHADONE HYDROCHLORIDE — METHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide