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.

15201–15225 of 88183

  • HighFDA (Drugs)·D-0203-2024·2024-01-03

    B-Complex Vitamin Injection Vials Recalled for Particulate Matter

    AnazaoHealth is recalling B-Complex injection vials due to particulate matter contamination. Affected patients should discontinue use and consult their healthcare provider.

    Product
    B-Complex, Thiamine HCI / Riboflavin / Niacinamide / Dexpanthenol / Pyridoxine HCI injection, 74/2/75/2/2 MG/ML, 30ML Sterile Multiple-Dose Vial, Rx only, AnazaoHealth, 7465 W Sunset Rd #1200, Las Vegas, NV 89113, NDC 72682-2230-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0163-2024·2024-01-03

    Albuterol Sulfate Inhaler Recalled Due to Temperature Storage Deviation

    Cardinal Healthcare is recalling Albuterol Sulfate inhalers (Batch K100715) due to CGMP deviations where products were exposed to temperatures outside labeled storage conditions. Approximately 11 cartons were distributed nationwide. Contact your pharmacist or doctor for a replacement.

    Product
    ALBUTEROL SULFATE — ALBUTEROL SULFATE (ALBUTEROL SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0201-2024·2024-01-03

    Warfarin Sodium Tablets Recalled Due to Temperature Storage Deviation

    Cardinal Healthcare recalls Warfarin Sodium Tablets (5 mg) nationwide due to CGMP deviations: products were exposed to temperatures outside labeled storage conditions, potentially affecting drug stability.

    Product
    WARFARIN SODIUM — WARFARIN SODIUM (WARFARIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0196-2024·2024-01-03

    Rivastigmine Transdermal Patch Recalled Due to Temperature Exposure

    Cardinal Healthcare is recalling Rivastigmine Transdermal System patches (4.6 mg/24 hours) distributed nationwide because they were exposed to temperatures outside labeled storage conditions during manufacturing.

    Product
    RIVASTIGMINE TRANSDERMAL SYSTEM, Delivers 4.6 mg/24 hours, 30 systems per box, Rx Only, Distributed by: Alvogen, Inc., Morristown, NJ 07960. NDC 47781-304-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0166-2024·2024-01-03

    Amoxicillin tablets recalled due to improper storage temperature exposure

    Cardinal Healthcare is recalling Amoxicillin 875mg tablets due to CGMP deviations where products were exposed to temperatures outside their labeled storage conditions, affecting nationwide distribution.

    Product
    AMOXICILLIN — AMOXICILLIN (AMOXICILLIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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
    1 state
  • HighFDA (Drugs)·D-0191-2024·2024-01-03

    Metoprolol Succinate Extended-Release Tablets Recalled for Storage Temperature Deviations

    Cardinal Healthcare is recalling Metoprolol Succinate Extended-Release Tablets (50 mg) nationwide. Batch 2447J211 was exposed to temperatures outside labeled storage conditions, which could compromise medication effectiveness.

    Product
    METOPROLOL SUCCINATE — METOPROLOL SUCCINATE (METOPROLOL SUCCINATE)
    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 (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 (Food)·F-0655-2024·2024-01-03

    Publix Egg Custard Pie Recalled for Undeclared Coconut

    Publix Super Markets is recalling Egg Custard Pie due to undeclared coconut, a tree nut allergen. Consumers with coconut allergies should not consume the product.

    Product
    EGG CUSTARD PIE, NET WT 25 OZ (1 LB 9 OZ) 709 g, packaged in paper carton with plastic film window, 6 cartons per case.
    Category
    Food
    Distribution
    1 state
  • 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-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-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-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-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-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 (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 (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
  • ModerateFDA (Drugs)·D-0182-2024·2024-01-03

    Fluticasone Propionate Nasal Spray Recalled for Temperature Storage Deviation

    Cardinal Healthcare is recalling Fluticasone Propionate Nasal Spray (50MCG per spray) due to CGMP deviations where products were exposed to temperatures outside labeled storage conditions. Nationwide distribution affected.

    Product
    FLUTICASONE PROPIONATE — FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0662-2024·2024-01-03

    Bowl & Basket Zero Calorie Sweetener recalled for undeclared aspartame

    Wakefern Foods Corp. is recalling Bowl & Basket Zero Calorie with Sucralose Sweetener due to undeclared aspartame and missing phenylalanine warning. The product poses a risk to consumers with phenylketonuria (PKU).

    Product
    Bowl & Basket Zero Calorie with Sucralose Sweetener 100 count, UPC 0-41190-06855-5, 12 retail cartons per wholesale case
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Drugs)·D-0194-2024·2024-01-03

    Propranolol Hydrochloride 20 mg Tablets Recalled for Temperature Storage Deviations

    Propranolol Hydrochloride tablets have been recalled nationwide. Products were exposed to temperatures outside labeled storage conditions during manufacturing, potentially affecting drug stability.

    Product
    PROPRANOLOL HYDROCHLORIDE — PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0619-2024·2024-01-03

    Liberty Select Cycler Displays Incorrect Timestamp on Treatment Reports

    Certain Liberty Select Cycler hemodialysis machines may display an incorrect timestamp on treatment data reports sent to clinics. No injuries or illnesses have been reported.

    Product
    Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0173-2024·2024-01-03

    Citalopram Tablets Recalled for Temperature Storage Deviation

    Cardinal Healthcare is recalling Citalopram 20mg tablets (batch 3131748) nationwide due to exposure to temperatures outside labeled storage conditions during manufacturing.

    Product
    CITALOPRAM — CITALOPRAM (CITALOPRAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0178-2024·2024-01-03

    Doxycycline Capsules Recalled Due to Temperature Storage Deviation

    Cardinal Healthcare is recalling Doxycycline 100 mg Capsules nationwide due to exposure to temperatures outside labeled storage conditions. No illnesses have been reported.

    Product
    DOXYCYCLINE — DOXYCYCLINE (DOXYCYCLINE)
    Category
    Drug
    Distribution
    Distributed nationwide