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.

1526–1550 of 88106

  • SevereFDA (Food)·H-1150-2026·2026-07-15

    High Valley Orchard Chocolate Covered Raisins Recalled for Undeclared Peanut

    High Valley Orchard Chocolate Covered Raisins (15oz bags) are recalled nationwide due to undeclared peanut from mis-packaging. Consumers with peanut allergies should not consume this product.

    Product
    High Valley Orchard Chocolate Covered Raisins, net wt. 15oz. per package, each case contains 12/15oz. bags. Product is packaged in clear plastic container. UPC on retail container: 0 952348 80170 0. The label of affected product declares: INGREDIENTS: MILK CHOCOLATE (SUGAR…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-1149-2026·2026-07-15

    Fresh to You Burger Chicken Fillet Recall for Salmonella Risk

    Fresh to You Burger Chicken Fillet sandwiches are being recalled because raw breaded chicken patties were inadvertently used instead of cooked ones, creating a risk of Salmonella foodborne illness.

    Product
    Fresh to You Burger Chicken Fillet, SKU 10150, Net wt. 5oz. Product is refrigerated. UPC 1 00000 01015 0. Manufactured By LPK1 Renton, WA. Product was not sold at retail stores and sold only to employees at certain business' breakroom.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2711-2026·2026-07-15

    Brachytherapy Applicator Advanced Gynecological Applicator Tip Detachment

    Elekta, Inc. is recalling Advanced Gynecological Applicators due to potential detachment of the intrauterine tube tip, which may remain inside a patient during cancer treatment.

    Product
    Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The intended use of the Advanced Gynecological Applicator is intracavitary brachytherapy for cancer treatment of the cervix and endometrium. Optional needles can be placed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0671-2026·2026-07-15

    Pemetrexed for Injection Recalled Due to Lack of Sterility Assurance

    Somerset Therapeutics is recalling Pemetrexed for Injection 100mg/Vial due to lack of sterility assurance. The recall affects approximately 12,000 vials distributed nationwide.

    Product
    Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0834-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-1140-2026·2026-07-15

    EC Hot Links Seasoning 45.05# Recalled for Undeclared Sesame

    Adams Extract & Spice LLC is recalling EC Hot Links Seasoning 45.05# due to undeclared sesame allergen. The product may pose a serious health risk to consumers with sesame allergies.

    Product
    EC Hot Links Seasoning 45.05#
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0672-2026·2026-07-15

    Pemetrexed for Injection recalled due to lack of sterility assurance

    Reliance Life Sciences is recalling Pemetrexed for Injection 500mg/Vial nationwide due to lack of sterility assurance. The affected product may not meet required sterility standards for intravenous use.

    Product
    Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0835-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-1138-2026·2026-07-15

    Smoked Sausage Spice recalled for undeclared sesame allergen

    Adams Extract & Spice LLC is recalling Smoked Sausage Spice due to undeclared sesame allergen. Consumers with sesame allergies should not use the affected product.

    Product
    Smoked Sausage Spice 32.86#
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·H-1145-2026·2026-07-15

    Vanilla Dessert Shells Recalled for Undeclared Soy Allergen

    Specialty Bakers, LLC is recalling Vanilla Dessert Shells (Giant) because they contain soy that is not declared on the label, posing a risk to consumers with soy allergies.

    Product
    Vanilla Dessert Shells (Giant), 6 dessert shells/1 package, 1 dessert shell is approximately 23.67 grams. 1package is 142 grams. 1 package has 1 plastic tray which holds 6 desserts shells. Plastic is wrapped around 1 tray. 24 packs/Case. Frozen
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2715-2026·2026-07-15

    VITEK 2 AST-N447 Test Kit Potentially Returns False Resistant Results

    Biomerieux Inc is recalling VITEK 2 AST-N447 TEST KIT (Lot 0853293604) distributed internationally due to potential false resistant carbapenem and/or cephalosporin results when pouch foil fractures are present.

    Product
    VITEK 2 AST-N447 TEST KIT Product reference 424620
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·H-1142-2026·2026-07-15

    Johnny's Salad and Pasta Elegance products recalled for undeclared sesame allergen

    Adams Extract & Spice LLC is recalling Johnny's Salad and Pasta Elegance seasoning products because they contain undeclared sesame, a known allergen. The recall affects two product sizes distributed in Texas.

    Product
    Johnny's Salad and Pasta Elegance 5.5 oz (UPC: 0-70381-10014-9) " Johnny's Salad and Pasta Elegance 2.75 oz (UPC: 0-70381-10013-2)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2703-2026·2026-07-15

    Atellica CH Enzymatic Hemoglobin A1c assay well-to-well bias

    Siemens is recalling an A1c blood test assay (Material Number 11097536) for the Atellica CH and Atellica CI analyzers due to potential intermittent bias that could cause falsely high or low hemoglobin A1c patient results.

    Product
    Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1147-2026·2026-07-15

    Alabama Banana Pudding Marshmallow Recall Due to Metal Contamination

    Wondermade LLC is recalling Alabama Banana Pudding Marshmallow products because they may contain small metal pieces. The affected 4-ounce boxes were distributed to Pennsylvania, Texas, Indiana, and Florida.

    Product
    Alabama Banana Pudding Marshmallow, 4 ounce 16 pieces of individual marshmallows packaged in a sealed plastic bag inside a printed cardboard box
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2698-2026·2026-07-15

    MiniMed 780G Insulin Pump Software Anomaly Recall

    Medtronic MiniMed's 780G Insulin Pump can stop delivering insulin due to a software anomaly when paired with the Instinct sensor, potentially leading to delayed therapy and increased risk of hyperglycemia or diabetic ketoacidosis.

    Product
    MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·H-1143-2026·2026-07-15

    Bakr Brown Butter Chocolate Chunk Cookie Dough Recalled for Undeclared Soy

    Bear Stewart Co is recalling Bakr Brown Butter Chocolate Chunk Ready to Bake Cookie Dough due to undeclared soy. The product was distributed in Southern California, Southern Nevada, Arizona, and Utah through Target stores.

    Product
    Bakr Brown Butter Chocolate Chunk Ready to Bake Cookie Dough, 8-oz pouch 12 cookies per pouch, UPC 8 50073 08700 8, 8 pouches per case
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2694-2026·2026-07-15

    Intracept Access Instruments sterile barrier breach risk

    Boston Scientific is recalling Intracept Access Instruments due to potential sterile barrier breach in the outer tray seal, which could introduce infection risk.

    Product
    Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS INSTRUMENTS- DRILL EU/RLV0035-EU, INTRACEPT ACCESS INSTRUMENTS- 2VB/RLV0045, INTRACEPT ACCESS INSTRUMENTS- 2VB EU/RLV0045-EU, INTRACEPT ACCESS INSTRUMENTS…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2700-2026·2026-07-15

    EMPOWR 3D Knee surgical device recalled due to packaging discrepancy

    Encore Medical, LP is recalling EMPOWR 3D KNEE surgical devices due to a packaging discrepancy where incorrect product sizes were mixed up in packaging.

    Product
    Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis knee devices are intended for knee arthroplasty.
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Drugs)·D-0663-2026·2026-07-15

    Medline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels

    Medline Remedy Specialized Silicone Cream is being recalled because formaldehyde levels exceeded the product specification. BioMed Laboratories is recalling approximately 509,652 tubes distributed nationwide.

    Product
    MEDLINE — MEDLINE (DIMETHICONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0669-2026·2026-07-15

    Isopropyl Alcohol 70% recalled for subpotency nationwide

    Drogueria San Juan Puerto Rico Isopropyl Alcohol 70% is recalled nationwide because the product is subpotent. The manufacturer Gasco Industrial Corp. initiated this voluntary recall.

    Product
    Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 16 oz, 474 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924, UPC 69685696529
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0668-2026·2026-07-15

    Drogueria San Juan Isopropyl Alcohol 70% Recalled for Subpotency

    Gasco Industrial Corp. is recalling Drogueria San Juan Puerto Rico Isopropyl Alcohol 70% (1 gallon) due to subpotency. The affected lots are 250221A5 and 250224A2 distributed nationwide.

    Product
    Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 1 gallon (3.78 liter), Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0670-2026·2026-07-15

    Drogueria San Juan Isopropyl Alcohol 70% recalled for subpotency

    Gasco Industrial Corp. is recalling Drogueria San Juan Puerto Rico Isopropyl Alcohol 70% (32 oz.) due to subpotency. Affected lots 250206B1, 250218B2, and 250507B1 were distributed nationwide in the US.

    Product
    Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 32 oz., 946 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana Llana Rio Piedras, PR 00924, UPC 659685696567.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0665-2026·2026-07-15

    Gasco Isopropyl Alcohol 70% Recalled for Subpotent Drug Content

    Gasco Industrial Corp. is recalling Gasco Isopropyl Alcohol 70% (16 oz bottles, Lot 250306B3) nationwide because the product is subpotent. Consumers should stop using the affected product and contact their healthcare provider if they have health concerns.

    Product
    Gasco Isopropyl Alcohol 70%, Net Contents: 16 Oz. (474 mL). Manufactured by: Gasco Industrial Corp., PO Box 1360 Gurabo PR 00778 Made in USA UPC 7 87302 13044 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2702-2026·2026-07-15

    5008X Blood Tubing Set connection errors FDA Class II recall

    Fresenius Medical Care is recalling 5008X Blood Tubing Sets due to potential online port errors that may occur when connecting the SafeLine to the substitution fluid port of the 5008X CAREsystem.

    Product
    5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush Standard Blood Tubing Set; Model Number: 03-5110-6. 2. 5008X HD Pre-Flush With Twister Blood Tubing Set; Model Number: 03-5160-1. 3. 5008X HD/HDF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2717-2026·2026-07-15

    Versius Surgical System Console affected by cybersecurity vulnerability

    CMR Surgical Limited is recalling the Versius Surgeon Console (Model V-SS-1020, Software Version Pratchett 1 version 62.1) due to Secure Boot not being enabled at manufacturing, presenting a potential cybersecurity risk.

    Product
    Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Software Version: Pratchett 1 version 62.1 Product Description: The Versius Surgical System is a modular, open console, software controlled, electromechanical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2714-2026·2026-07-15

    OmniTract Surgical Retractor System sterilization instructions require extended dry time

    Integra LifeSciences is recalling the OmniTract Surgical Retractor System because the sterilization instructions require a longer dry time than stated in the current manual. The dry time must be extended to 90, 110, or 120 minutes depending on the sterilization cycle used.

    Product
    OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2696-2026·2026-07-15

    Medline Convenience Kits containing temperature probes recalled

    Medline Industries is recalling Convenience Kits containing Covidien Mon-a-Therm General Purpose Temperature Probes due to an error in distribution control. The recall affects 75 kits distributed nationwide.

    Product
    Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569D; 2) ACCESSORY KIT, Model Number: DYNJ901348F
    Category
    Medical Device
    Distribution
    Distributed nationwide