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.

11801–11825 of 27206

  • HighFDA (Drugs)·D-0446-2024·2024-04-24

    Thyroid pharmaceutical ingredient recalled for failed stability specifications

    Specialty Process Labs is recalling S.P.Labs Thyroid, Full Strength (NDC 81305-500-01) due to failed stability specifications. The ingredient was distributed nationwide for pharmaceutical manufacturing use.

    Product
    S.P.Labs, Thyroid, Full Strength, Rx only, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-500-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1152-2024·2024-04-24

    Peanut Butter Filled Iced Donuts Recalled for Metal Contamination

    Weis Markets is recalling Peanut Butter Filled Iced Donuts due to foreign material (metal) found in the product. Affected donuts were distributed at a retail store in Pennsylvania with sell-by dates between March 15–18, 2024.

    Product
    Bakery Item Peanut Butter Filled Iced Donuts 6 ct. scale UPC: 2128800005501 packaged in a cardboard box. Product is also separately in the self service case in the store bakery. Customers can put their selected donut(s) in a bag or clamshell container.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1533-2024·2024-04-24

    Surgical Sutures Recalled for Sterility Compromise During Transit

    Ethicon recalls 395 units of STRATAFIX surgical sutures (lot SHBAEC) due to sterility compromise from environmental exposure during transit and storage. Product is unsuitable for surgical use.

    Product
    STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS PRM- Indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product Code: SXMP2B412
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1543-2024·2024-04-24

    Smiths Medical Medfusion Pump Guide Barrel Clamp Molding Defect Recall

    Smiths Medical is recalling Medfusion Guide Barrel Clamps due to a molding defect that could cause spring slippage, preventing the pump from recognizing or correctly identifying loaded syringes.

    Product
    Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0447-2024·2024-04-24

    Specialty Process Labs Recalls Thyroid USP Drug Ingredient for Failed Stability

    Specialty Process Labs is recalling Thyroid, USP, a pharmaceutical ingredient used in drug manufacturing, due to failed stability specifications. Seven lots distributed nationwide are affected.

    Product
    S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Use only, Specialty Process Labs, Phoenix, AZ, NDC #'s a) 81305-100-01, b)81305-100-02, c)81305-100-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1539-2024·2024-04-24

    Masimo Rad-G Pulse Oximeter Recall: Risk of Automatic Power Loss

    Masimo Corporation is recalling 65 Masimo Rad-G pulse oximeters due to a potential defect causing automatic power cycling that could result in loss of patient monitoring.

    Product
    Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1593-2024·2024-04-24

    Microalbumin Calibrator Series Recall Due to Measurement Accuracy Issue

    FDA recalls Microalbumin Calibrator Series due to negative measurement bias that may misclassify patient results. Laboratories using affected batches should review quality control data and consider recalibration.

    Product
    Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1532-2024·2024-04-24

    Cook Coons Taper Dilators recalled due to low packaging seal strength

    Cook Incorporated is recalling 4,856 Coons Taper Dilators because packaging may have low seal strength, compromising device sterility. These percutaneous dilators are used in vascular and non-vascular procedures and are distributed worldwide.

    Product
    Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. REFERENCE PART NUMBER (RPN)/ORDER NUMBER (GPN): 1) JCD10.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1530-2024·2024-04-24

    Cook Incorporated Dilators Recalled for Low Packaging Seal Strength

    Cook Incorporated is recalling 5,998 dilators worldwide because packaging may not meet seal strength specifications, potentially compromising device sterility.

    Product
    Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. 1) JCD10.0-38-20 2) JCD20.0-38-20 3) JCD22.0-38-20 4) JCD6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0443-2024·2024-04-24

    Digoxin Tablets Recalled Due to Failed Impurity and Degradation Specifications

    Novitium Pharma LLC is recalling 1,003 bottles of Digoxin tablets (Lot M23011A, expiring 12/2024) distributed nationwide due to failed impurity and degradation specifications. Patients should consult their healthcare provider immediately.

    Product
    DIGOXIN — DIGOXIN (DIGOXIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1173-2024·2024-04-24

    Abdallah Sea Salt Almond Alligators Recalled for Wrong Back Label

    Abdallah Candies is recalling Sea Salt Almond Alligators due to incorrect back label showing chocolate covered cherries information instead of the actual product.

    Product
    Abdallah Sea Salt Almond Alligators. Net Weight 8 ounces (226g). UPC 7 66684-00412 2. Abdallah Candies, Made in Apple Valley, MN.
    Category
    Food
    Distribution
    15 states
  • ModerateFDA (Food)·F-1149-2024·2024-04-24

    Windsor Black Peppercorns Mislabeled; Contains Pink Himalayan Salt Instead

    Windsor Black Peppercorns are mislabeled. Products labeled as black peppercorn actually contain Pink Himalayan salt. Affected lot code ZX23060001, distributed in Canada.

    Product
    Windsor Black Peppercorns, 34g grinder, UPC 0 66010 08200 9, 6 units per wholesale case
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1153-2024·2024-04-24

    Aromitalia Malasia Coconut Paste Recalled for Missing Coconut Allergen in Contains Statement

    Aromitalia Malasia Coconut Paste is being recalled because coconut is listed in the ingredients but not declared in the contains statement, potentially affecting consumers with coconut allergies.

    Product
    Aromitalia Malasia Coconut Paste + 35.27 oz milk-based mix, Net Weight 123.46 oz, plastic container.
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-0441-2024·2024-04-24

    Prescription drug NEXLIZET recalled for dissolution specification failure

    Esperion is recalling certain NEXLIZET (bempedoic acid and ezetimibe) tablets nationwide because the active ingredient may not dissolve properly, potentially reducing effectiveness.

    Product
    NEXLIZET — NEXLIZET (BEMPEDOIC ACID AND EZETIMIBE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1524-2024·2024-04-24

    Baxter surgical tool marketing brochures contain inaccurate Instructions for Use

    Baxter Healthcare Corporation recalled marketing brochures for surgical tools that contain inaccurate information conflicting with the product Instructions for Use. Over 82,000 units were distributed worldwide.

    Product
    Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Vascular Probe, Item Numbers: a) 708101
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1596-2024·2024-04-24

    NPWT Canister Recalled Due to Carbon Filter Contamination Risk

    Smith & Nephew is recalling RENASYS EDGE 300ML canisters due to black particulate matter from the carbon filter that may enter the pump. The recall affects 6,895 units distributed in the US, Canada, and Chile.

    Product
    RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing. Product Number: 66803139
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1140-2024·2024-04-17

    Robeson Enterprises Mo' Money Pie Recalled for Undeclared Soy Allergen

    Robeson Enterprises is recalling Mo' Money Pie due to undeclared soy allergen on the label. The product was distributed to Georgia, North Carolina, and South Carolina.

    Product
    PIES & SIDES MO' MONEY PIE INGREDIENTS: BLACK EYED PEAS, COLLARDS, ELBOW PASTA, CHEESES, CORNMEAL, BLEACHED FLOUR, MILK PRODUCTS, SPICES. CONTAINS: MILK, EGG, WHEAT PIES & SIDES MOUNT HOLLY, NC
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0440-2024·2024-04-17

    FDA Class I Recall: Methocarbamol Injection for Particulate Matter

    Eugia US LLC is recalling Methocarbamol Injection nationwide due to particulate matter contamination. The FDA classified this as a Class I recall affecting lot 3MC23011 (expiration 11/30/2026).

    Product
    METHOCARBAMOL — METHOCARBAMOL (METHOCARBAMOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1143-2024·2024-04-17

    Pumpkin Pie Recalled Due to Undeclared Milk and Egg Allergens

    Robeson Enterprises recalls PIES & SIDES brand pumpkin pie because the product label fails to list undeclared milk and eggs, posing a risk to consumers with these allergies.

    Product
    PIES & SIDES PUMPKIN PIE 10.5 oz INGREDIENTS: PUMPKIN FILLING, SUGARS, VANILLA, BLEACHED FLOUR, SPICES, CONTAINS: WHEAT PIES & SIDES MOUNT HOLLY, NC
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1484-2024·2024-04-17

    Ivenix Infusion System Software Recalled for Potential Dosing Anomalies

    Fresenius Kabi USA is recalling Ivenix Infusion System software version 5.8.0 for anomalies that could cause incorrect medication dosing or therapy delays. The Class I recall affects 17 units across 13 US states.

    Product
    LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Food)·F-1139-2024·2024-04-17

    Baked Mac and Cheese Recalled for Undeclared Egg Allergen and Missing Ingredients

    Robeson Enterprises is recalling 482 units of PIES & SIDES Baked Mac and Cheese because the label fails to declare egg as an allergen and does not list any ingredients. Products were distributed to Georgia, North Carolina, and South Carolina.

    Product
    PIES & SIDES BAKED MAC AND CHEESE, ALLERGENS: MILK, PIES & SIDES MOUNT HOLLY, NC
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1124-2024·2024-04-17

    Naturz Organics Pea Protein Recalled for Possible Salmonella Contamination

    Naturz Organics is recalling Organic Pea Protein (Item Code NO-OPP-80, 20 kg bags) due to possible salmonella contamination. The recall affects bulk product distributed to one consignee in Wisconsin.

    Product
    Naturz Organics Organic Pea Protein, Item Code NO-OPP-80, Net Weight 20 KG Bulk product packaged in paper bags.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1136-2024·2024-04-17

    Deep South Tomato Pie Recalled for Undeclared Eggs

    Robeson Enterprises is recalling Deep South Tomato Pie because the label does not list sub-ingredients, and pimento cheese in the product may contain undeclared eggs. Consumers with egg allergies should not consume this product.

    Product
    PIES & SIDES DEEP SOUTH TOMATO PIE, INGREDIENTS: SLICED TOMATOES, PIMENTO CHEESE, BLEACHED FOUR, MILK PRODUCTS, SPICES. CONTAINS: SOY, FISH, WHEAT, MILK PIES & SIDES MOUNT HOLLY, NC
    Category
    Food
    Distribution
    3 states