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.

9101–9125 of 27089

  • HighFDA (Drugs)·D-0007-2025·2024-10-09

    Pluvicto Radiopharmaceutical Drug Recalled Due to Manufacturing Quality Deviations

    Advanced Accelerator Applications is recalling 99 doses of Pluvicto (lutetium LU-177 injection) due to manufacturing quality deviations. The affected lots were distributed to six states.

    Product
    Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufacturer Advanced Accelerator Applications, 57 E. Willow Street, NJ 07041, Millburn USA. NDC 69488-0010-61
    Category
    Drug
    Distribution
    6 states
  • HighFDA (Drugs)·D-0001-2025·2024-10-09

    Prescription atorvastatin bottles recalled for containing wrong medication

    A carbamazepine (anticonvulsant) tablet was found in bottles of atorvastatin (cholesterol medication). The affected lot includes 2,328 bottles distributed nationwide.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0006-2025·2024-10-09

    Miami J Select Collar Recalled Due to Adhesive Failure

    Ossur is recalling Miami J Select Collars due to pressure-sensitive adhesive hooks that may peel off during repeated use, potentially reducing cervical spine immobilization effectiveness.

    Product
    Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-3308-2024·2024-10-09

    DVOT Rapid Antigen Test Kits Recalled for Lack of FDA Authorization

    DVOT antigen test kits lack FDA authorization for US sale. Approximately 50,000 unauthorized kits were distributed. Users should discontinue use immediately due to unvalidated safety and accuracy.

    Product
    DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number ACT01
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3312-2024·2024-10-09

    Medical Display Unit Recalled for Unintended Touch Input During Patient Monitoring

    Philips DIVA 24-inch touch display may generate unintended touch inputs, risking erroneous acknowledgement of patient alarms and delayed detection of patient condition changes. No injuries have been reported.

    Product
    DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD2461AMI Philips Part # 866126
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0006-2025·2024-10-09

    Sqwincher Electrolyte Beverage Mix recalled for potential metal contamination

    Kent Precision Foods Group is recalling Sqwincher Electrolyte Beverage Mix (Orange powder, lot 2B0165712) due to potential metal contamination. The product was distributed in 11 states.

    Product
    Sqwincher Electrolyte Beverage Mix, Orange powder pack, Net Wt 47.66 oz (3lb) 1.35 kg: UPC 7588008834 / 16 per case / 5 gal yield item number 159016404
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-0004-2025·2024-10-09

    Ceremonial Cacao Paste Recalled for Elevated Lead Levels

    Heart of the Earth ceremonial cacao paste is being recalled due to elevated lead levels in the product. Consumers should not consume this product and should contact a healthcare provider if they have concerns.

    Product
    Heart of the Earth (HOTE) 100% Pure Ceremonial Cacao Pre-Ground Paste. Net Wt. 16oz (454g). Packaged in Kraft paper heat sealed stand-up pouch bags with inner plastic liner with SKU PC-GRUCCP-1LB. Product of Guatemala. Distributed Soul Lift Cacao of Portland, Oregon. The produc
    Category
    Food
    Distribution
    15 states
  • HighFDA (Devices)·Z-3303-2024·2024-10-09

    Urinalysis reagent strips recalled for reduced protein detection sensitivity

    Healgen Scientific is recalling 1,636,994 urinalysis test strips in California, Georgia, and Texas due to reduced protein detection sensitivity that may produce false negative results and delay kidney disease diagnosis.

    Product
    Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is employed for testing one assay item by visually or instrumentally reading the color change of the pad and comparing with the corresponding blocks on a color chart.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0022-2025·2024-10-09

    Cranberry Muffins Recalled for Undeclared Milk and Wheat Allergens

    The Posh Bakery is recalling Cranberry Muffins due to undeclared whey (milk) and wheat flour, as well as missing nutrition facts panel and allergen statement. Consumers with milk or wheat allergies should not consume these products.

    Product
    Whole Grains Bakery labeled "Cranberry Muffin", 6 oz. Whole Grains Bon Croissant, Sacramento, CA 95826, (916)-793-0090
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0007-2025·2024-10-09

    Philips IntelliVue G7m Anesthesia Gas Module Pump Failure

    Philips IntelliVue G7m Anesthesia Gas Modules may have a faulty sample gas pump that could stop working, interrupting gas measurement. Affected devices have serial numbers DE43800129 through DE43812627.

    Product
    IntelliVue G7m Anesthesia Gas Module, Product Number 866173
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3311-2024·2024-10-09

    Contact lenses with misaligned axis may cause poor visual acuity

    CooperVision is recalling Biofinity Toric Multifocal soft contact lenses manufactured with misaligned axes resulting in incorrect optical power. Affected lenses may cause poor visual acuity.

    Product
    Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3313-2024·2024-10-09

    Alcon contact lenses recalled for manufacturing quality defect

    Alcon is recalling approximately 92,835 packs of contact lenses because a material quality issue may affect lens performance standards. Wearers may experience temporary eye irritation, redness, or blurred vision.

    Product
    DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-3305-2024·2024-10-09

    Atellica IM aTPO Assay Diagnostic Test Recalled for Measurement Bias

    Siemens Healthcare Diagnostics is recalling 9783 kits of the Atellica IM aTPO Assay diagnostic test due to positive bias in patient results below the 60 U/mL cut-off level, which may produce inaccurate test results.

    Product
    Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0019-2025·2024-10-09

    Hemodialysis console blood leak sensor may fail to trigger alarm

    A component in certain Tablo Hemodialysis consoles may fail to detect small blood leaks promptly, potentially causing symptoms like hypotension, fatigue, and dizziness if undetected blood loss occurs.

    Product
    Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Food)·F-0018-2025·2024-10-09

    Blueberry muffins recalled for undeclared milk and wheat allergens

    The Posh Bakery, Inc. is recalling Whole Grains Blueberry Muffins (6 oz) due to undeclared milk (whey) and wheat flour, with missing allergen labeling and nutrition facts panel.

    Product
    Whole Grains Bakery labeled "Blueberry Muffin", 6 oz. Whole Grains Bon Croissant, Sacramento, CA 95826, (916)-793-0090 UPC"7 13583 05 102 3"
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0001-2025·2024-10-09

    KARA BOONDHI Recalled for Undeclared Wheat Allergen

    Grace Imports is recalling KARA BOONDHI due to undeclared wheat allergen on the label. The affected product was distributed to retail stores in Georgia.

    Product
    KARA BOONDHI INGREDIENTS: Gram flour, Edible beg oil (Refined Palmolein Oil), Chilly powder, Curry leaf, pepper, Asafoetida, Corn Flour, Urid dhall, Black salt. Natural Antioxidant (Mixed Tocopherol INS 305) ALLERGEN INFORMATION: Made in a FActory that Process Peanuts, Tree nuts,
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-3310-2024·2024-10-09

    BIOFINITY XR TORIC Contact Lenses Recalled for Misaligned Axis Defect

    CooperVision is recalling 607 BIOFINITY XR TORIC soft contact lenses due to a manufacturing defect with misaligned axis, resulting in incorrect power and poor visual acuity. The lenses were distributed in the US and Canada.

    Product
    BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3309-2024·2024-10-09

    Stryker Tornier Shoulder Implant Insert May Not Seat Securely

    Tornier Inc. is recalling 38 Stryker Tornier Perform Humeral System Reversed Inserts (model REF DWP2393) due to inverted locking rings. The defect may prevent the insert from seating securely in the implant stem or spacer.

    Product
    Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3304-2024·2024-10-09

    ADVIA Centaur aTPO Assay kits recalled due to positive result bias

    Siemens Healthcare is recalling 5,622 ADVIA Centaur aTPO Assay kits due to test accuracy issues. The affected lots produce results that are biased higher at and below the 60 U/mL threshold.

    Product
    ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0012-2025·2024-10-09

    Big Bottom Milk Company Chocolate Milk Recalled for Inadequate Pasteurization

    Big Bottom Milk Company is recalling chocolate milk that was not properly pasteurized. The recall affects 251 units distributed to Georgia, North Carolina, and South Carolina.

    Product
    BIG BOTTOM MILK COMPANY, CHOCOLATE MILK GRADE A, 1 US Half Gallon (1.89 liters), Big Bottom Milk Company 221 Hogan Rd, Forest City, NC, Expiration Date 09/09/2024 UPC code 850061506054
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0017-2025·2024-10-09

    Chocolate chip muffins recalled for undeclared milk and wheat

    The Posh Bakery is recalling Whole Grains chocolate chip muffins due to undeclared milk and wheat allergens with missing allergen labeling. Those with milk or wheat allergies should not consume this product.

    Product
    Whole Grains Bakery labeled "Choclate Chip Muffin", 6 oz. Whole Grains Bon Croissant, Sacramento, CA 95826, (916)-793-0090 UPC"7 13583 05 105 4"
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0020-2025·2024-10-09

    Banana nut muffins recalled for undeclared milk and wheat allergens

    The Posh Bakery recalls Whole Grains Bakery Banana Nut Muffins (6 oz) due to undeclared milk and wheat allergens. The muffins lack required allergen-contains statements and nutritional fact labels.

    Product
    Whole Grains Bakery labeled "Banana Nut Muffin", 6 oz. Whole Grains Bon Croissant, Sacramento, CA 95826, (916)-793-0090 UPC"7 13583 05 101 6"
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0003-2025·2024-10-09

    Spicy Murukku Snack Recalled for Undeclared Wheat Allergen

    Grace Imports is recalling Spicy Murukku snack due to undeclared wheat on the label. Consumers with wheat allergies face serious health risks from unlabeled exposure.

    Product
    SPICY MURUKKU INGREDIENTS: Rice Flour, Edible Veg Oil (Refined Palmolein Oil), Salt, Salt, Chilly powder, Roasted Bengal Gram Flour***Asafoetida, Natural Antioxidant (Mixed Tocopherol INS 305) ALLERGEN INFORMATION: Made in a Factory that Process Peanuts, Tree nuts, Soy, Milk, Wh
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0014-2025·2024-10-09

    Poppy Seed Muffins Recalled Due to Undeclared Milk, Wheat, and Almond Allergens

    The Posh Bakery is recalling 6-ounce Poppy Seed Muffins due to undeclared milk (whey), wheat, and almond allergens. The product lacks required allergen labeling, posing a risk to consumers with allergies.

    Product
    Whole Grains Bakery labeled "Poppy Seed Muffin", 6 oz. Whole Grains Bon Croissant, Sacramento, CA 95826, (916)-793-0090 UPC "7 13583 05 103 0"
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0007-2025·2024-10-09

    Sqwincher Electrolyte Beverage Mix Recalled for Potential Metal Contamination

    Kent Precision Foods Group is recalling Sqwincher Electrolyte Beverage Mix in four flavors due to potential metal contamination. The affected powdered beverages were distributed across 11 states.

    Product
    1. Sqwincher Electrolyte Beverage Mix, orange powder packs, Net Wt 23.83 oz (1 lb 8 oz) 675.6 g: UPC 7588025004; packaged in assorted case, 32 per case / 2.5 gal yield item number 159016044 2. Sqwincher Electrolyte Beverage Mix, grape powder packs, Net Wt 23.83 oz (1 lb 8 oz) 67
    Category
    Food
    Distribution
    11 states