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.

13126–13150 of 27263

  • HighFDA (Drugs)·D-0273-2024·2024-01-31

    Fexofenadine Hydrochloride Antihistamine Tablets Recalled for Microbial Contamination

    Sun Pharmaceutical is recalling Fexofenadine Hydrochloride 180mg tablets due to microbial contamination discovered in manufacturing equipment. Approximately 54,504 bottles distributed nationwide are affected by this Class II recall.

    Product
    FEXOFENADINE HYDROCHLORIDE — FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0791-2024·2024-01-31

    Chocoflan Dessert Recalled for Undeclared Wheat and Other Allergens

    Lara's Bakery 3 LLC is recalling Chocoflan dessert products for undeclared wheat and potential cross-contamination with sesame, coconut, soy, milk, and eggs. Consumers with allergies should not consume this product.

    Product
    Chocoflan (Chocolate Custard Dessert), Net Wt 1/2 lb, packaged in plastic clamshell.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0793-2024·2024-01-31

    C.R. Bard Nasogastric Sump Tubes recalled for inadequate drainage and suction

    C.R. Bard is recalling Bard Nasogastric Sump Tubes with ENFit connectors due to user reports of inadequate suction and drainage. The recall affects 16,564 units distributed in the United States.

    Product
    Bard¿ Nasogastric Sump Tube with ENFit, 16Fr., 48in Long, REF EN0042160
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0814-2024·2024-01-31

    TactiFlex Ablation Catheter Not Properly Recognized by EnSiteX EP System

    The TactiFlex Ablation Catheter is not correctly recognized by the EnSiteX EP System, which displays it as a different model, prevents certain features from appearing, and may show an inverted image.

    Product
    TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0776-2024·2024-01-31

    Frozen Vegan Pizza Recalled for Undeclared Milk Allergen

    365 Whole Foods Vegan Ultimate Veggie pizza (13.7 oz, UPC 0 99482-51870 7) is recalled for undeclared milk. Consumers with milk allergies should not consume this product. It was distributed to GA, PA, TX, and WA.

    Product
    365 Whole Foods Vegan Ultimate Veggie, Thin Cust Pizza. Item # 999209512 Topped with Vegan Mozzarella-Style Cheese, Green and Red Bell Peppers, Mushrooms, Black Olives and Red Onions. Net Wt 13.7 oz (388g) UPC 0 99482-51870 7. Keep Frozen. Distributed by Whole Foods Market,
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0772-2024·2024-01-31

    VITROS Anti-HBs Immunodiagnostic Products Recalled for Calibration Failures

    Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products used to test for Hepatitis B antibodies due to potential calibration failures and falsely elevated test results affecting specific lot numbers.

    Product
    VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0792-2024·2024-01-31

    Tres Leches Cake Recalled for Undeclared Wheat Allergen

    Lara's Bakery 3 LLC is recalling Tres Leches cake for undeclared wheat, a major allergen not listed despite being in the ingredient list. Consumers with wheat allergies could face allergic reactions.

    Product
    Tres Leches (Three Milk Cake), Net Wt 1/2 lb, packaged in plastic clamshell.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0800-2024·2024-01-31

    Bard Nasogastric Sump Tube Recalled for Reduced Suction and Drainage

    C.R. Bard is recalling Bard Nasogastric Sump Tubes due to reports of inadequate or reduced suction, decompression, and drainage during use. The recall affects 57,159 units distributed in the United States.

    Product
    Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 18Fr., 48in Long, REF EN0046180
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0813-2024·2024-01-31

    Ultrasound system recalled due to measurement error in Dual Live Compare feature

    B-K Medical A/S is recalling bkActiv Ultrasound System 2300 models because a measurement error could occur in the Dual Live Compare feature, potentially affecting diagnostic accuracy.

    Product
    bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0268-2024·2024-01-31

    Mesalamine Tablets Recalled for Manufacturing Equipment Microbial Contamination

    Sun Pharmaceutical recalls 10,690 bottles of Mesalamine tablets nationwide due to microbial contamination found in manufacturing equipment. Patients should contact their healthcare provider.

    Product
    MESALAMINE — MESALAMINE (MESALAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0271-2024·2024-01-31

    Zolpidem Tartrate Tablets Recalled Due to Manufacturing Equipment Contamination

    Sun Pharmaceutical is recalling approximately 1220 bottles of Zolpidem Tartrate Extended-Release 6.25 mg tablets distributed nationwide due to microbial contamination detected in manufacturing equipment.

    Product
    ZOLPIDEM TARTRATE — ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0266-2024·2024-01-31

    Prescription Drug Recall: Lurasidone Hydrochloride Tablets for Microbial Contamination

    Sun Pharmaceutical is recalling 11,400 bottles of Lurasidone Hydrochloride 60mg tablets due to microbial contamination in manufacturing equipment. Patients taking this medication should contact their doctor or pharmacist.

    Product
    LURASIDONE HYDROCHLORIDE — LURASIDONE HYDROCHLORIDE (LURASIDONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0263-2024·2024-01-31

    Prescription Drug Cinacalcet Tablets Recalled for Manufacturing Contamination

    Sun Pharmaceutical is recalling 1,728 bottles of Cinacalcet Tablets 60mg due to microbial contamination found in manufacturing equipment. No illnesses have been reported.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0257-2024·2024-01-31

    Benzonatate Capsules Nationwide Recall for Above-Specification Assay Results

    Amerisource Health Services is recalling 6,344 cartons of Benzonatate 100 mg capsules nationwide due to assay results that were slightly above specification. No illnesses or injuries have been reported.

    Product
    BENZONATATE — BENZONATATE (BENZONATATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0807-2024·2024-01-31

    MRI system warning label defect presents electrical shock risk to service personnel

    Achieva 1.5T MR systems have incorrect warning labels on the Liquid Cooling Cabinet, missing the high voltage warning symbol. This presents a potential electrical shock risk for service personnel.

    Product
    Achieva 1.5T, Model No. 781178, 781196, 781296
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0812-2024·2024-01-31

    MRI Cooling Cabinet Has Incorrect Electrical Warning Label

    Cooling cabinets in Philips MRI systems have defective electrical warning labels with incorrect colors and a missing high voltage warning symbol, creating electrical shock risk for service personnel.

    Product
    SmartPath to dStream for 1.5T, Model No. 781260, 782112
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0270-2024·2024-01-31

    Prescription Niacin Tablets Recalled for Microbial Contamination

    Sun Pharmaceutical is recalling Niacin Extended-Release Tablets nationwide due to microbial contamination found in manufacturing equipment. Affected lot numbers expire in June and July 2025.

    Product
    NIACIN — NIACIN (NIACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0259-2024·2024-01-31

    Fluocinolone Acetonide Ear Drops Recalled Due to Failed Specification

    Glenmark Pharmaceuticals is recalling Fluocinolone Acetonide Oil 0.01% ear drops due to failed excipient specifications. The affected lots nationwide do not meet required quality standards for isopropyl alcohol content.

    Product
    FLUOCINOLONE ACETONIDE — FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0778-2024·2024-01-31

    Market Basket Organic Trek Mix recalled for vegetation contamination

    Market Basket Organic Trek Mix (11oz and 14oz bags) is being recalled due to the presence of stem and vegetation foreign material. The affected lot #23354 was distributed to Maryland, Oregon, and Massachusetts.

    Product
    Market Basket, Organic Trek Mix, 11oz & 14oz. plastic resealable bags . 8/11oz & 12/14oz bags per case.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0810-2024·2024-01-31

    Medical Device MRI Cooling Cabinet Warning Label Missing High-Voltage Symbol

    Philips Ingenia Ambition X MRI systems contain an incorrect warning label on the cooling cabinet. The label is missing high-voltage warning symbols, creating a potential electrical shock risk for service personnel.

    Product
    Ingenia Ambition X, Model No. 782109
    Category
    Medical Device
    Distribution
    Distributed nationwide