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.

13451–13475 of 27263

  • HighFDA (Drugs)·D-0189-2024·2024-01-03

    Lithium Carbonate Extended-Release Tablets Recalled for Temperature Excursion

    Cardinal Healthcare recalled Lithium Carbonate Extended-Release Tablets (300 mg, Batch 3138326) distributed nationwide because the products were exposed to temperatures outside their labeled storage conditions during manufacturing.

    Product
    Lithium Carbonate Extended-Release Tablets, USP, 300 mg, 100 Tablets per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-1300-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0184-2024·2024-01-03

    Drug Recall: Hydralazine Hydrochloride Tablets Due to Improper Storage

    Cardinal Healthcare is recalling Hydralazine Hydrochloride tablets nationwide because products were exposed to temperatures outside labeled storage conditions due to manufacturing practice deviations.

    Product
    HYDRALAZINE HYDROCHLORIDE — HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0171-2024·2024-01-03

    Bumetanide Tablets Recalled for Exposure to Improper Storage Temperatures

    Bumetanide tablets manufactured by Amneal Pharmaceuticals are being recalled because they were exposed to temperatures outside their labeled storage conditions. The recall affects batch AM211171 distributed nationwide.

    Product
    Bumetanide Tablets, USP, 2 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213 India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0616-2024·2024-01-03

    Landauer microSTARii reader recalled for measurement inaccuracy

    Landauer microSTARii readers may provide inaccurate dosimetry measurements due to LED beam profile issues and debris formation. Inaccuracy may not be detected without regular quality control testing. 584 units affected worldwide.

    Product
    Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0199-2024·2024-01-03

    Triamterene and Hydrochlorothiazide Capsules Recalled for Temperature Storage Deviation

    Triamterene and Hydrochlorothiazide Capsules (37.5 mg/25 mg) are being recalled nationwide due to temperature exposure during manufacturing that fell outside labeled storage conditions. Affected batches are 21000279A and 21000280A.

    Product
    Triamterene and Hydrochlorothiazide Capsules, USP, 37.5 mg/25 mg, 100 capsules per bottle, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19136. NDC 0527-1632-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0193-2024·2024-01-03

    PredniSONE Tablets Recalled for Temperature Storage Deviation

    Cardinal Healthcare is recalling PredniSONE 20 mg tablets nationwide (Batch 21P0659, NDC 59746-175-06) due to exposure to temperatures outside labeled storage conditions during manufacture, which could affect drug stability.

    Product
    PredniSONE Tablets, USP, 20 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801. NDC: 59746-175-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0205-2024·2024-01-03

    Sertraline Hydrochloride Tablets Recalled Due to Manufacturing Process Defect

    Legacy Pharmaceutical Packaging LLC is recalling 161,664 bottles of Sertraline Hydrochloride 100 mg tablets distributed in California and Arkansas due to inadequate line clearance during manufacturing that may result in product comingling.

    Product
    SERTRALINE HYDROCHLORIDE — SERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0170-2024·2024-01-03

    Low-dose aspirin recall due to improper storage temperature conditions

    Cardinal Healthcare is recalling low-dose aspirin tablets nationwide due to a CGMP deviation involving improper storage temperatures. Products may have been exposed to conditions outside the manufacturer's labeled storage requirements, potentially affecting product stability.

    Product
    ASPIRIN — ASPIRIN (ASPIRIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0615-2024·2024-01-03

    Medtronic SynchroMed II Programmable Pump May Fail to Resume Drug Delivery After MRI

    The Medtronic SynchroMed II pump may fail to resume medication delivery after an MRI scan if the device switches to telemetry mode due to electromagnetic interference while alarming. The pump will not resume normal operation after leaving the MRI magnetic field.

    Product
    Medtronic SynchroMed II, Model 8637-40, Programmable pump
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0622-2024·2024-01-03

    DeRoyal Cardiac Cath Kit Recalled for Defective Pressure Transducers

    DeRoyal Industries is recalling a cardiac catheterization kit that contains Edwards Life Sciences pressure transducers that were subject to a separate recall by their manufacturer.

    Product
    DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0613-2024·2024-01-03

    Alinity ci-series System Control Module Software Performance Issues Recalled

    Abbott Laboratories is recalling 8,424 Alinity ci-series System Control Module units due to software performance issues that could produce erroneous test results. Affected systems are used in clinical laboratories throughout the United States and 90+ countries.

    Product
    Alinity ci-series System Control Module, REF: 03R70-01
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-0614-2024·2024-01-03

    Medtronic SynchroMed II Pump May Fail to Resume Drug Delivery After MRI

    The Medtronic SynchroMed II pump may fail to resume drug delivery after MRI if electromagnetic interference triggers telemetry mode while the pump is alarming. This could interrupt essential medication delivery in patients.

    Product
    Medtronic SynchroMed II, Model 8637-20, Programmable pump
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0188-2024·2024-01-03

    FDA Recalls Lisinopril and Hydrochlorothiazide Tablets Due to Temperature Storage Deviations

    Cardinal Healthcare is recalling Lisinopril and Hydrochlorothiazide Tablets (10mg/12.5mg) manufactured by Lupin Limited because products were exposed to temperatures outside the labeled storage conditions. Affected batches are Q101699 and Q101981 distributed nationwide.

    Product
    LISINOPRIL AND HYDROCHLOROTHIAZIDE — LISINOPRIL AND HYDROCHLOROTHIAZIDE (LISINOPRIL AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0204-2024·2024-01-03

    FDA Recalls AnazaoHealth Injectable Vitamin Solution Due to Particulate Matter

    AnazaoHealth Corporation is recalling 3,363 vials of Thiamine HCl/Pyridoxine HCl injection solution nationwide due to the presence of particulate matter. Affected lots are identified by lot numbers and expiration dates listed by the FDA.

    Product
    Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution, 30mL Amber Glass Vial, Rx only, AnazaoHealth, 7465 W. Sunset Road, Las Vegas, NV, NDC 72682-8721-3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0176-2024·2024-01-03

    Donepezil Hydrochloride tablets recalled for improper storage temperature

    Donepezil Hydrochloride 10mg tablets are recalled due to exposure to temperatures outside labeled storage conditions. The FDA classified this Class II recall due to potential effects on drug stability.

    Product
    DONEPEZIL HYDROCHLORIDE — DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0180-2024·2024-01-03

    Estradiol 0.5mg Tablets Recalled Nationwide for Storage Temperature Deviation

    Cardinal Healthcare is recalling Estradiol 0.5mg tablets (Batch 100023687) nationwide due to exposure to temperatures outside labeled storage specifications. Temperature exposure may affect medication stability.

    Product
    ESTRADIOL — ESTRADIOL (ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0161-2024·2024-01-03

    Respiratory inhalation medication recalled for temperature storage deviation

    Cardinal Healthcare is recalling an ipratropium bromide and albuterol sulfate inhalation solution nationwide after the product was exposed to temperatures outside labeled storage conditions. The deviation may affect drug potency.

    Product
    IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE — IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE (IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0202-2024·2024-01-03

    Prescription Inhalation Powder Recalled for Storage Temperature Deviation

    Cardinal Healthcare recalls batch 62002532 of Wixela Inhub inhalation powder nationwide due to CGMP deviations. Products were exposed to temperatures outside labeled storage conditions, potentially affecting product stability.

    Product
    WIXELA INHUB — WIXELA INHUB (FLUTICASONE PROPIONATE AND SALMETEROL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0192-2024·2024-01-03

    Topical antifungal Nyamyc recalled due to storage temperature deviations

    Cardinal Healthcare is recalling Nyamyc topical antifungal medication (Batch 400454) nationwide due to exposure to temperatures outside labeled storage conditions.

    Product
    Nyamyc, 100,000 USP units per gram, 60 grams, Rx only, Topical Use Only, Manufactured by: Upsher-Smith Laboratories, Inc, Minneapolis, MN 55447.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0181-2024·2024-01-03

    Lansoprazole Suspension Recalled Due to Temperature Storage Deviations

    A prescription lansoprazole suspension has been recalled because batches were exposed to temperatures outside the manufacturer's labeled storage range. This manufacturing quality issue affects Batch 21025A nationwide.

    Product
    FIRST LANSOPRAZOLE PT 3MG/ML, 300ML, Rx Only, Distributed By: CutisPharma, Inc., Woburn, MA 01801. NDC: 65628-080-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0611-2024·2024-01-03

    Arjo Medical Beds Recalled Due to Unintended Wheel Movement

    Arjo medical beds with IndiGo Drive Assistance modules may have wheels that move unintentionally. This recall affects 83 units in seven U.S. states.

    Product
    Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0618-2024·2024-01-03

    Acumed RibLoc U Plus 90 Surgical Guide Recalled for Potential Breakage

    Acumed LLC recalls 513 RibLoc U Plus 90 surgical guides due to potential breakage during use. The device is used in orthopedic rib fixation procedures.

    Product
    RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The RBL2320, Low Profile Primary Guide is an instrument used with a power system to compress the RibLoc plates onto the bone, determine the length of the screw to install, locate the position of the holes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0621-2024·2024-01-03

    Atrium Oasis surgical drain recalled for premature sterilization expiration

    Atrium Oasis surgical drain recalled due to sterilization nonconformance that shortened the product's shelf life. Affected units were distributed nationwide and may not maintain sterility if used after November 17, 2025.

    Product
    Atrium Oasis Drain Single W / AC, Part No. 3600-100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0612-2024·2024-01-03

    Arjo medical beds with unintended wheel movement recalled

    Arjo medical beds with IndiGo Drive Assistance modules may experience unintended wheel movement. The recall affects 846 units distributed across seven US states.

    Product
    Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules
    Category
    Medical Device
    Distribution
    7 states