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.

9851–9875 of 88183

  • HighFDA (Food)·F-0311-2025·2024-12-25

    L'Oven Fresh KETO Tortilla Wraps recalled for possible metal contamination

    Rise Baking Company is recalling L'Oven Fresh KETO Friendly Original 6 Tortilla Wraps sold at Aldi stores in five states due to potential metal contamination. Affected products carry specific Julian date codes from 24 302 to 24 311.

    Product
    L'Oven Fresh KETO Friendly Original 6 Tortilla Wraps. Net Wt. 7.8 oz(222g) UPC 4099100271348. Dist & Sold Exclusively By: Aldi, Batavia, IL 60510. Product of Canada
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0285-2025·2024-12-25

    Impossible Spicy Ground Sausage Recalled for Potential Metal Contamination

    Impossible Foods is recalling Impossible Spicy Ground Sausage due to potential metal pieces in the product. The recall affects 32,536 cases distributed nationwide with use-by dates between June 28, 2025 and January 28, 2026.

    Product
    Impossible Spicy Ground Sausage Meat from plants 14oz chub, UPC 8 16697 02109 5; 8 retail chubs per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0312-2025·2024-12-25

    L'Oven Fresh KETO Tortilla Wraps Recalled for Metal Contamination

    L'Oven Fresh KETO Friendly Multiseed 6 Tortilla Wraps are being recalled due to potential metal contamination. Products were distributed in CT, KS, MN, OH, and TX.

    Product
    L'Oven Fresh KETO Friendly Multiseed 6 Tortilla Wraps. Net Wt. 7.8 oz(222g) UPC 4099100271355. Dist & Sold Exclusively By: Aldi, Batavia, IL 60510. Product of Canada
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0699-2025·2024-12-25

    Femoral Knee Prosthesis Components May Have Incorrect Packaging

    MicroPort Orthopedics recalls EVOLUTION MP femoral knee prosthesis components due to incorrect packaging. The devices are correctly marked internally but may have wrong labels on their packaging.

    Product
    EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR NON-POROUS SIZE 6 LEFT PRIMARY, REF: EFSRN6PL Knee prosthesis component
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0701-2025·2024-12-25

    Augustine HOT DOG Temperature Management Controller Instructions Update

    Augustine Temperature Management is issuing an instructions for use update for its HOT DOG warming controllers (Models WC77, WC77D, WC77R) regarding a power-on self-test error code.

    Product
    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0141-2025·2024-12-25

    Patterson Dental Topical Anesthetic Recalled for Manufacturing Quality Defect

    Keystone Industries is recalling one lot of Patterson Dental Topical Anesthetic due to manufacturing quality deviations. The product was shipped despite being marked for rejection due to scratches in the mixing vessel.

    Product
    PATTERSON DENTAL TOPICAL ANESTHETIC — PATTERSON DENTAL TOPICAL ANESTHETIC (BENZOCAINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0148-2025·2024-12-25

    FDA Recalls Benzo-Jel Topical Anesthetic Gel Due to Manufacturing Defect

    Henry Schein's Benzo-Jel Topical Anesthetic Gel is being recalled due to manufacturing quality deviations. Scratches were discovered on the mixing vessel after the product had been inadvertently released and distributed to customers.

    Product
    Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (29.6 mL), Distributed by Henry Schein, Melville, NY 11747, For Professional Use Only,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0691-2025·2024-12-25

    K-Systems R65 embryo incubator temperature may exceed setpoint

    CooperSurgical's K-Systems R65 Trolley reproductive incubators may experience temperature excursions above desired setpoints, though devices will alarm when this occurs. The FDA issued a Class II recall of 43 units across eight U.S. states.

    Product
    Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and…
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Drugs)·D-0137-2025·2024-12-25

    Benzocaine Topical Anesthetic Recalled for Manufacturing Equipment Defect

    Gelato Benzocaine 20% topical anesthetic (Lot BNZ-001646) is recalled due to scratches found in the mixing vessel during manufacturing. The defective product was inadvertently released despite quality control rejection, though no illnesses have been reported.

    Product
    GELATO TOPICAL ANESTHETIC — GELATO TOPICAL ANESTHETIC (BENZOCAINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0147-2025·2024-12-25

    Benzocaine Topical Gel Recalled Due to Manufacturing Quality Defect

    Keystone Industries recalls Ipana 20% Benzocaine Topical Gel due to a manufacturing quality issue. The bulk product was released from a mixing vessel with scratches despite Quality Unit rejection.

    Product
    Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0143-2025·2024-12-25

    Topical anesthetic gel recall due to manufacturing quality control deviation

    Keystone Industries recalls Burkhart Topical Anesthetic Gel due to CGMP deviations discovered during quality inspection. The product was inadvertently released despite being flagged for rejection.

    Product
    Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30 ml), Manufactured for Burkhart Dental Supply, Tacoma, Washington 98409.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0700-2025·2024-12-25

    HOT DOG Temperature Management Controller Instructions for Use Update

    Augustine Temperature Management is updating instructions for HOT DOG Patient Warming Controllers (Models WC71, WC71R) regarding a power-on self-test error code. The update affects 135 units distributed in the US and Canada.

    Product
    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0145-2025·2024-12-25

    Topical Anesthetic Gel Recalled for Manufacturing Process Deviation

    Safco SensiCaine Ultra Topical Anesthetic Gel is being recalled due to a manufacturing process deviation. Product that should have been rejected because of damage to the mixing vessel was inadvertently released to customers.

    Product
    SAFCO SENSICAINE ULTRA TOPICAL ANESTHETIC GEL — SAFCO SENSICAINE ULTRA TOPICAL ANESTHETIC GEL (BENZOCAINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0154-2025·2024-12-25

    Olanzapine 2.5 mg Tablets Recalled for Failed Impurity Specifications

    Macleods Pharmaceuticals is recalling Olanzapine 2.5 mg tablets nationwide due to failed impurities and degradation specifications. The recall affects one production lot distributed across the United States.

    Product
    OLANZAPINE — OLANZAPINE (OLANZAPINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0150-2025·2024-12-25

    Dihydroergotamine Mesylate Injection recalled due to discoloration

    Provepharm Inc. is voluntarily recalling Dihydroergotamine Mesylate Injection nationwide due to discoloration in specific lots. Patients should contact their healthcare provider if they have used the affected product.

    Product
    DIHYDROERGOTAMINE MESYLATE — DIHYDROERGOTAMINE MESYLATE (DIHYDROERGOTAMINE MESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0684-2025·2024-12-25

    Eclipse PRO Holter Recorders Recalled for Serial Number Mismatch

    Spacelabs Healthcare recalls 13,202 Eclipse PRO Holter recorders due to manufacturing error where the programmed serial number may not match the physical label. Affected devices were manufactured between April 2021 and November 2024.

    Product
    Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram.
    Category
    Medical Device
    Distribution
    22 states
  • ModerateFDA (Devices)·Z-0685-2025·2024-12-25

    ECG Patch Recorder Serial Number Mismatch - Eclipse Mini

    Spacelabs Healthcare is recalling the Eclipse Mini ECG patch recorder because incorrect serial numbers may be programmed into devices, causing a mismatch between the physical label and internal serial number.

    Product
    Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to record the patient s electrocardiogram.
    Category
    Medical Device
    Distribution
    22 states
  • CriticalFDA (Food)·F-0260-2025·2024-12-18

    Con Yeager Trail Bologna Meat Processing Kit recalled for undeclared wheat and soy

    Con Yeager Spice Company is recalling Trail Bologna Meat Processing Kits because they contain undeclared wheat and soy allergens. Affected consumers with allergies should not consume the product.

    Product
    Con Yeager Spice Company, Trail Bologna Meat Processing Kit, 17.88 Ounce pouches, UPC code 797442404137
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Food)·F-0272-2025·2024-12-18

    Organic Broccoli Medley Recalled Due to E. coli O121 Contamination Risk

    4Earth Farms is recalling Organic Broccoli Medley packages due to potential E. coli O121:H19 contamination. The product was distributed across multiple states to retail and distribution centers.

    Product
    Organic Broccoli Medley, 4Earth Farms, Net Weight 12 oz (340 g) Washed and ready to prepare, Perishable keep refrigerated. Distributed by 4Earth Farms, LLC., Commerce, CA 92022 USA
    Category
    Food
    Distribution
    8 states
  • CriticalFDA (Food)·F-0278-2025·2024-12-18

    Broccoli medley recalled for potential E. coli O121:H19 contamination

    4Earth Farms is recalling 6,036 cases of broccoli medley due to potential contamination with E. coli O121:H19. The product was distributed to retailers and distribution centers across multiple states.

    Product
    Broccoli Medley, 4Earth Farms, Net Weight 12 oz (340 g) (6 pack/case) Washed and ready to prepare, Perishable keep refrigerated. Distributed by 4Earth Farms, LLC., Commerce, CA 92022 USA
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·F-0279-2025·2024-12-18

    Organic Broccoli Slaw from 4Earth Farms Recalled for E. coli O121 Contamination

    4Earth Farms is recalling Organic Broccoli Slaw for potential E. coli O121:H19 contamination. Products were distributed to retail and distribution centers across multiple states.

    Product
    Organic Broccoli Slaw (Salade DE Brocoli), 4Earth Farms, Net Weight/Poids Net (340 g) 12oz (6 pack/case) Washed and ready to prepare, Perishable keep refrigerated. Distributed by 4Earth Farms, LLC., Commerce, CA 92022 USA
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·F-0270-2025·2024-12-18

    Marketside Fresh Cut Cucumber Slices Recalled for Salmonella Risk

    Walmart is recalling Marketside Fresh Cut Cucumber Slices sold in Texas due to potential Salmonella contamination. Consumers should not eat this product and should return or dispose of it.

    Product
    Marketside Fresh Cut Cucumber Slices. In clear deli plastic container with lid. Weights vary. Perishable. Keep Refrigerated. Distributed by Walmart, Inc., Bentonville, AR 72716.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0271-2025·2024-12-18

    Mediterranean Party Tray Recalled for Potential Salmonella Contamination

    F&S Produce West LLC is recalling Mediterranean Party Trays (sell-by dates 11/27/2024–12/11/2024) due to potential Salmonella contamination in the tzatziki sauce. The product was distributed to 187 retail locations in seven western states.

    Product
    Mediterranean Inspired Party Tray; Sell by dates 11/27/2024- 12/11/2024 UPC: 826766145966; Perishable, Keep Refrigerated
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-0276-2025·2024-12-18

    Organic Vegetable Medley Recalled for E. coli O121 Contamination Risk

    4 Earth Farms is recalling Organic Vegetable Medley (Broccoli, Carrots & Cauliflower) sold at Walmart due to potential contamination with E. coli O121:H19. The recall affects 6,036 cases distributed across multiple states.

    Product
    Organic Vegetable Medley; Broccoli, Carrots & Cauliflower. Washed and ready to prepare; Perishable keep refrigerated. NET WT 12 OZ (340g) (6 pack/case) DISTRIBUTED BY: Walmart Inc., Bentonville, AR 78716
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·F-0280-2025·2024-12-18

    Organic Carrots Recalled for Potential E. coli O121:H19 Contamination

    4Earth Farms is recalling 6,036 cases of organic carrots distributed across multiple states due to potential E. coli O121:H19 contamination.

    Product
    Organic Carrots. Bulk 1 pound bags. Washed and ready to prepare, Perishable keep refrigerated. Distributed by 4Earth Farms, LLC., Commerce, CA 92022 USA
    Category
    Food
    Distribution
    8 states