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.

13851–13875 of 27206

  • SevereFDA (Drugs)·D-0224-2024·2023-12-06

    FDA recalls Artri King tablets for undeclared diclofenac

    Botanical Be is recalling 235 bottles of Artri King tablets sold nationwide. The tablets contain undeclared diclofenac and were marketed without FDA drug approval.

    Product
    Artri King Reforzado con Origa y Omega 3 tablets, packaged in 100-count bottles, Manufactured by: Plantas medicinales de Mexico, Melchol Ocampo # 65 Local D, Delegacion Xochimilco CP 16800, Mexico DF, UPC 7 501031 111138
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0225-2024·2023-12-06

    Reumo Flex caplets recalled for undeclared diclofenac content nationwide

    Reumo Flex caplets packaged in 30-count boxes are being recalled because they contain undeclared diclofenac and were marketed without FDA approval. The product was distributed nationwide.

    Product
    Reumo Flex caplets, packaged in 30-count boxes, Manufactured by: Grupo Yepenza de Mexico, SA de CV, Comerciantes 5824 Col Arcos de Guadalupe, Zapopan Jal Mexico, UPC 7 502214 014598
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0473-2024·2023-12-06

    Tuna Salad Recalled for Undeclared Milk and Soy Allergens

    Le Croissant Tuna Salad (5.8oz) is recalled due to undeclared milk and soy allergens. Consumers with allergies to these allergens should not consume the product.

    Product
    Le Croissant Tuna Salad Net Wt. 5.8oz (164g) UPC:766375261605 Packaged in clamshell container. Sold under Food Unlimited brand. Sold as single unit and 6-unit pack
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0480-2024·2023-12-06

    GreenGate Fresh Spinach Recalled for Potential E. coli Contamination

    GreenGate Fresh Cello Spinach is being recalled due to potential E. coli (EHEC) contamination. The recall involves 11 cases distributed to eight consignees across seven U.S. states.

    Product
    GreenGate Fresh Standard Cello Spinach; 4 - 2.5lb plastic bags per box; SKU 465; Perishable hence require refrigeration at all times of its shelflife
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0226-2024·2023-12-06

    Kuka Flex Forte caplets recalled for undeclared diclofenac and lack of FDA approval

    Botanical Be is recalling Kuka Flex Forte caplets nationwide because they contain undeclared diclofenac and were marketed without required FDA approval. All lots expire 12/12/2024.

    Product
    Kuka Flex Forte caplets, packaged in 30-count bottles, Manufactured by: Kukamonga, Gonzalez Ortega No 170 Col Centro, 44100 Guadalajara Jal, UPC 0736640810265
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0145-2024·2023-12-06

    Prescription drug oral solution recalled for microbial contamination

    Bayer Healthcare Pharmaceuticals Inc. is recalling 192 bottles of VITRAKVI (larotrectinib) oral solution due to microbial contamination identified as Penicillium brevicompactum during routine testing.

    Product
    VITRAKVI — VITRAKVI (LAROTRECTINIB)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0476-2024·2023-12-06

    Eltahan Golden Raisins 400g recalled for undeclared sulfites

    Eltahan Inc. is recalling Eltahan Golden Raisins (400g, UPC 2337660022) distributed in NY, NJ, and PA due to undeclared sulfites, which can cause severe allergic reactions.

    Product
    Eltahan Golden Raisins 400 gm. Packaged in a clear plastic bag. UPC 2337660022
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0470-2024·2023-12-06

    Frito-Lay Chickpea Veggie Crisps recalled for undeclared milk allergen

    Frito-Lay is recalling 16,100 bags of Chickpea Veggie Crisps (UPC 02840020646) due to undeclared milk allergen. Consumers with milk allergies should not consume the product.

    Product
    Chickpea Veggie Crisps, Net Wt. 6 1/4 oz (177.1g), UPC: 02840020646
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0415-2024·2023-12-06

    Olympus colonoscope repair defect may impair imaging and suction function

    Aizu Olympus is recalling 24 colonoscopes with defective repairs to the light guide connector. The defect may prevent proper imaging, reduce suction, and impair device cleaning, potentially exposing patients to contamination.

    Product
    CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0423-2024·2023-12-06

    RAPIDPOINT 500 Blood Gas System: Drug Interference May Cause False Sodium Readings

    Siemens RAPIDPOINT 500 Blood Gas System may produce falsely elevated sodium results due to drug interference from Perhexiline Maleate or Atomoxetine Hydrochloride. This could lead to missed hyponatremia or inappropriate treatment of hypernatremia.

    Product
    RAPIDPOINT 500 Blood Gas System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0406-2024·2023-12-06

    Da Vinci Needle Driver Recalled for Risk of Dislodgement During Surgery

    Intuitive Surgical is recalling 317 units of a Da Vinci Single-Site Wristed Needle Driver due to potential dislodgement or breakage that could result in uncontrollable movement.

    Product
    Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Food)·F-0471-2024·2023-12-06

    Breakfast sandwich recalled for undeclared milk and soy allergens

    Food Unlimited Breakfast Sandwich Bacon Egg & Cheddar Croissants are recalled due to undeclared milk and soy allergens. The affected products have Use By dates from 10/27/2023 to 11/8/2023.

    Product
    Breakfast Sandwich Bacon Egg & Cheddar Croissant Net Wt. 5.25oz (149g) UPC:766375253051. Packaged in clamshell container. Sold as single unit and 6 unit pack under Food Unlimited brand
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0414-2024·2023-12-06

    Edwards TruWave pressure monitoring kit recalled for setup issues

    Edwards Lifesciences is recalling 168,014 TruWave with Vamp pressure monitoring kits due to potential flushing difficulties during setup. The recall affects devices distributed across the US and internationally.

    Product
    TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 (3cc)/VAMP PXVK0364:(3cc)/VAMP 96in (241cm); PXVK0853: x3 (3cc)/VAMP 76in (193cm); PXVK0996:(3cc)/VAMP 68in (174cm); PXVMP2X21: x2 (3cc)/VAMP; PXVMP2X22: x2 (3cc)/VAMP 63 in
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-0411-2024·2023-12-06

    FloTrac Sensor Recalled Due to Potential Flushing Difficulties During Setup

    Edwards Lifesciences is recalling 1417 FloTrac Sensors used for intravascular pressure monitoring due to potential flushing difficulties during kit setup. No illnesses or injuries have been reported.

    Product
    FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intravascular pressure monitoring.
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-0417-2024·2023-12-06

    Gastrointestinal Videoscope Recall Due to Improper Repair and Infection Risk

    Aizu Olympus recalls 24 gastrointestinal videoscopes with improperly repaired light guide connectors. The defect may cause loss of image and suction, preventing proper device reprocessing and risking patient infection.

    Product
    GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Food)·F-0468-2024·2023-12-06

    Bonta Stracciatella gelato recalled due to undeclared soy lecithin

    Bonta Natural Artisan Gelato Stracciatella is being recalled due to undeclared soy lecithin. Soy is a major allergen; consumers with soy allergies should not consume this product.

    Product
    Bonta Natural Artisan Gelato Stracciatella is frozen dessert, packaged in blue cardboard pint cups (UPC 58745 00309) and in green cardboard half-gallon tubs (UPC 58745 00306). The 1 Pint label is read in parts: "Stracciatella Sweet Cream Freckled with crunchy 70% Dark Chocolate.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0123-2024·2023-12-06

    Prescription Drug Indomethacin Recalled Due to Label Mix-Up

    Glenmark Pharmaceuticals is recalling 37,200 bottles of Indomethacin 25mg capsules distributed nationwide because the bottles may be labeled as Naproxen instead. This labeling error could cause medication confusion.

    Product
    INDOMETHACIN — INDOMETHACIN (INDOMETHACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0419-2024·2023-12-06

    Olympus EVIS EXERA III Colonoscope Recall for Connector Defect

    24 Olympus EVIS EXERA III colonoscopes distributed to six states are recalled due to improperly repaired connectors that may cause image loss, decreased suction, or improper reprocessing, potentially exposing patients to contaminated equipment.

    Product
    PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Drugs)·D-0122-2024·2023-12-06

    Paroxetine Hydrochloride Tablets Recalled for Out-of-Specification Impurity

    Apotex Corp. is recalling Paroxetine Hydrochloride 40 mg tablets nationwide due to failed quality specifications. Testing found out-of-specification impurity levels in affected lot numbers.

    Product
    PAROXETINE — PAROXETINE (PAROXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0478-2024·2023-12-06

    Fanta Orange in 12-pack cans recalled due to potential foreign material

    United Packers is recalling Fanta Orange in 12-pack aluminum cans due to potential foreign material. The affected product (Lot No. JUL2924MBD3) was distributed to Alabama, Florida, and Mississippi.

    Product
    Fanta Orange packaged in 12oz aluminum cans - 12 pack fridge pack
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0466-2024·2023-12-06

    California Baking Company Telera Bread Recalled for Undeclared Milk Allergen

    California Bread Co. is recalling Telera Bread products due to undeclared milk allergen. The recall involves 8,959 packages distributed in California.

    Product
    California Baking Company Telera Bread (La Torta Bread), 6 pack (26 oz) and 12 pack (58 oz), plastic bags
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0400-2024·2023-12-06

    BD Insyte Autoguard IV Catheter Needles May Fail to Retract Properly

    BD Insyte Autoguard BC IV catheters may have needles that fail to retract properly, potentially causing contaminated needlestick injuries, blood leakage, and repeated insertion attempts.

    Product
    BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0479-2024·2023-12-06

    Sprite 12-ounce cans recalled due to potential foreign material

    United Packers, LLC is recalling Sprite in 12-ounce aluminum cans distributed in Alabama, Florida, and Mississippi due to potential foreign material contamination.

    Product
    Sprite packaged in 12oz aluminum cans - 12 pack fridge pack
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-0128-2024·2023-12-06

    Paroxetine Tablets Recalled Due to Out-of-Specification Impurity Levels

    Paroxetine tablets are being recalled for failing specification tests due to higher-than-acceptable levels of a degradation impurity. Approximately 1,941 bottles distributed nationwide are affected.

    Product
    PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-734-30; b) 90-count bottle NDC 60429-734-90; c)1000-count bottle, NDC 60429-734-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 9
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0124-2024·2023-12-06

    Prescription Naproxen 250mg tablets recalled for labeling mix-up with indomethacin

    Glenmark Pharmaceuticals is recalling Naproxen Sodium 250mg tablets nationwide due to a labeling mix-up where Indomethacin bottles may be labeled as Naproxen. Patients could receive the wrong medication.

    Product
    NAPROXEN SODIUM — NAPROXEN SODIUM (NAPROXEN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide