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.

8951–8975 of 27089

  • ModerateFDA (Food)·F-0064-2025·2024-10-30

    Horizon Organic Ultra Pasteurized Heavy Whipping Cream recalled for potential premature spoilage

    Horizon Organic Dairy is recalling approximately 2,956 cases of Ultra Pasteurized Heavy Whipping Cream (BEST BY 10/22/24) distributed across 14 states due to the potential for premature spoilage during shelf life.

    Product
    Horizon Organic Ultra Pasteurized Heavy Whipping Cream, refrigerated, One Pint (473ml), UPC 7 42365 21685 5. There are 12 cartons per case. Distributed by: Horizon Organic Dairy, LLC (Horizon) Broomfield, CO 80021.UPC: 742365216855
    Category
    Food
    Distribution
    14 states
  • ModerateFDA (Drugs)·D-0018-2025·2024-10-30

    Vancomycin Injection Recalled Due to Manufacturing Process Violations

    Fresenius Kabi Compounding is recalling Vancomycin HCl injectable medication due to cGMP manufacturing violations. The recall affects 1,082 bags distributed to 125 healthcare accounts nationwide.

    Product
    Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-014-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0041-2025·2024-10-23

    Perilla Leaves in Soy Sauce recalled for undeclared wheat and fish allergens

    Lemonland Food Corp recalls Item FLD1000BA Perilla Leaves in Soy Sauce due to undeclared wheat and fish allergens on the label. Consumers with these allergies should not consume the product.

    Product
    Item FLD1000BA, Perilla Leaves in Soy Sauce, distributed in plastic clamshell containers, net wt. 0.315lb. The H-Mart label declares: Perilla Leaves, Soy Sauce, Sugar
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0012-2025·2024-10-23

    Atovaquone Oral Suspension Recalled for Cohnella Bacteria Contamination

    Bionpharma Inc. is recalling Atovaquone Oral Suspension (750 mg/5 mL) nationwide due to Cohnella bacteria contamination. The recall affects 1,980 bottles.

    Product
    ATOVAQUONE — ATOVAQUONE (ATOVAQUONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0038-2025·2024-10-23

    Potato Salad Recall: Undeclared Egg and Soybean Allergens

    Lemonland Food Corp is recalling potato salad due to undeclared egg and soybean allergens present in the mayonnaise ingredient. The recall affects 120 packages distributed in Washington.

    Product
    Item FLD4006, Potato Salad, distributed in plastic clamshell containers, net wt. 0.56lb. The H-Mart label declares: Potato, Mayonnaise, Sugar, Vegetable.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0037-2025·2024-10-23

    Nuts.com recalls S'mores Bites for undeclared milk allergen

    Nuts.com is recalling S'mores Bites due to undeclared milk allergen. Milk chocolate was listed in the product description but omitted from the ingredient list, creating a labeling mismatch.

    Product
    S'mores Bites, 1 yummy pound, Distributed by Nuts.com, Cranford, NJ, 07016
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Food)·F-0046-2025·2024-10-23

    Octopus Product Recalled for Undeclared Fish Allergen

    Lemonland Food Corp is recalling Item FLD2011 Salted and Seasoned Small Octopus because it contains undeclared fish (anchovy), a major allergen. Approximately 70 packages were distributed in Washington state.

    Product
    Item FLD2011, Salted and Seasoned Small Octopus, distributed in plastic clamshell containers, net wt. 0.267lb. The H-Mart label declares: Octopus, Salt, Garlic, Ginger, Red Pepper Powder, Green Onion, Syrup, Sesame Seed.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0044-2025·2024-10-23

    Seasoned Dandelion Recalled for Undeclared Fish Allergen

    Lemonland Food Corp is recalling Item FLD1070A Seasoned Dandelion due to undeclared fish (anchovy) not listed on the label. Consumers with fish allergies should not consume this product.

    Product
    Item FLD1070A, Seasoned Dandelion, distributed in plastic clamshell containers. Net wt. 0.365lb. The H-Mart label declares: Dandelion, Salt, Garlic, Soy Sauce, Chili Powder.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0036-2025·2024-10-23

    Enjoy Premium Coconut Cookies Recalled for Undeclared Milk Allergen

    KTM Services, Inc. is recalling Enjoy Premium Coconut Cookies sold in Hawaii, Guam, Nevada, and online due to undeclared milk allergen. Consumers with milk allergies should not consume the product.

    Product
    Enjoy Premium Coconut Cookies packaged in 5.3 oz. foil pouches and 17.7 oz clear bags
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0043-2025·2024-10-23

    Seasoned Radish Recalled for Undeclared Crustacean Allergen

    Lemonland Food Corp is recalling Item FLD1080A Seasoned Radish due to undeclared shrimp. The product was distributed in Washington; consumers with crustacean allergies should not consume it.

    Product
    Item FLD1080A, Seasoned Radish, distributed in plastic clamshell containers, net wt. 0.365lb. The H-Mart label declares: Radish, Red Pepper Powder, Malt Syrup, Salt, Anchovy, Sugar, Garlic, Ginger, Sesame.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0048-2025·2024-10-23

    Seasoned Pepper with Soybean Paste Recalled for Undeclared Allergens

    Lemonland Food Corp is recalling Item FLD1020A Seasoned Pepper with Soybean Paste due to undeclared wheat, fish, and crustacean allergens. Consumers with allergies should not consume this product.

    Product
    Item FLD1020A, Seasoned Pepper with Soybean Paste, distributed in plastic clamshell containers. Net wt. 0.315lb. The H-Mart label declares: Pepper, Soy Bean Paste.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0035-2025·2024-10-23

    Enjoy Premium Taro Cookies recalled for undeclared milk allergen

    Enjoy Premium Taro Cookies contain undeclared milk allergen and were sold in Hawaii, Guam, and Nevada. Consumers with milk allergies should not consume this product.

    Product
    Enjoy Premium Taro Cookies packaged in 5.3 oz. foil pouches and 17.7 oz clear bags
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0047-2025·2024-10-23

    GE HealthCare Giraffe OmniBed neonatal incubator door screw may loosen

    Certain GE HealthCare Giraffe OmniBed and Carestation neonatal incubators may have door-securing screws that were not torqued to specification, potentially causing the doors to become loose. These units are distributed worldwide.

    Product
    GE Heathcare Giraffe OmniBed; neo natal incubator
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0122-2025·2024-10-23

    Medline Open Heart Surgical Kit Recall for Model Labeling Error

    Medline Industries recalls certain open-heart surgical kits (Lot 23LBR364) due to incorrect model labeling, where model 30001 units were labeled as model 30000. The recall affects 30 units distributed nationwide.

    Product
    MEDLINE OPEN HEART, REF DYNJ904261B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0053-2025·2024-10-23

    Dietary supplement with Rauwolscine recalled for potential Salmonella contamination

    Gorilla Mind Rauwolscine dietary supplement is recalled nationwide due to potential Salmonella contamination. Consumers should not use the product and contact the manufacturer.

    Product
    Gorilla Mind Rauwolscine Dietary Supplement, Suppress Appetite, Increased Fat Loss, Increased Energy, dosage 3mg, 90 capsules per bottle, UPC 8 50017 02016 0. Product is manufactured for Gorilla Mind LLC 7154 W. State Street, STE 138, Boise, ID. Product label declares "***Suppl
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0088-2025·2024-10-23

    Leica Cryostat Model CM1900 Lacks Warning on Flammable Sprays

    Leica Biosystems is recalling the Cryostat Model CM1900 because its labeling lacks a warning about using flammable freezing sprays in the chamber. The sprays can ignite, creating a serious fire and burn hazard.

    Product
    Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491900UVU2; for freezing and sectioning tissue samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0118-2025·2024-10-23

    Beckman Coulter Recalls Immunochemistry IGM Reagent Lots for Sensitivity Failure

    Beckman Coulter is recalling two lots of IGM reagent used in IMMAGE immunochemistry systems because they don't meet sensitivity specifications. The reagent measures immunoglobulin M levels in blood samples.

    Product
    IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 1, is intended for the quantitative determination of immunoglobulin M (IGM) in human serum by rate nephelometry.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0086-2025·2024-10-23

    Leica Biosystems Cryostat lacks warning for flammable freezing spray use

    Leica Biosystems Cryostat Model CM1510 S is recalled due to missing warning labels about flammable freezing sprays, which can ignite and cause serious injury. The device labeling lacked fire hazard warnings prior to 2019.

    Product
    Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b) 1491510C003; for freezing and sectioning tissue samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0034-2025·2024-10-23

    Bevi Flavor#115 Electrolytes Recalled: Mislabeled, Contains Caffeine

    Hydration Labs Inc. is recalling Flavor#115 Electrolytes (3.78L BIB units) distributed nationwide and in Canada because the product is labeled as electrolytes but actually contains caffeine.

    Product
    Flavor#115 Electrolytes, Net Contents 3.78L, #740-0115, GTIN barcode 00850010449043. Product is packaged as a Bag In Box (BIB) single unit for use in Bevi Smart Water Cooler machines dispensing flavored waters.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0042-2025·2024-10-23

    Seasoned Dried Whiting with Undeclared Wheat Allergen Recalled

    Lemonland Food Corp recalls Seasoned Dried Whiting due to undeclared wheat allergen. Consumers with wheat allergies should discard or return the product.

    Product
    Item FLD1004A, Seasoned Dried Whiting, distributed in plastic clamshell containers, net wt. 0.315lb. The H-Mart label declares: Dried Pollack, Starch Syrup, Soy Sauce, Red Pepper Powder, Sesame Seeds.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0039-2025·2024-10-23

    Lemonland Food Corp Recalls Perilla Leaves in Soybean Paste for Undeclared Wheat and Sesame

    Lemonland Food Corp recalls Item FLD1000A Perilla Leaves in Soybean Paste distributed in Washington. The product label omits wheat and sesame seeds, which are present in the product.

    Product
    Item FLD1000A, Perilla Leaves in Soybean Paste, distributed in plastic clamshell containers, net wt. 0.315lb. The H-Mart label declares Perilla Leaves, Soybean Paste.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0049-2025·2024-10-23

    Lemonland Wild Leeks Recalled for Undeclared Wheat and Fish Allergens

    Lemonland Food Corp is recalling Item FLD1040A Wild Leeks distributed in Washington due to undeclared wheat and fish (anchovy) allergens. The product label declares soy sauce but omits mandatory allergen warnings.

    Product
    Item FLD1040A, Wild Leeks, distributed in plastic clamshell containers. Net wt. 0.315lb. The H-Mart label declares: Wild Leeks, Sugar, Soy Sauce.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0059-2025·2024-10-23

    Monarch Inflation Device Recalled Due to Sterile Barrier Breaches

    Merit Medical Systems is recalling 1,120 Monarch Inflation Devices due to manufacturing defects causing holes and breaches in the sterile Tyvek barrier. Affected devices distributed worldwide may pose contamination risk during cardiac interventions.

    Product
    Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device REF IN2330 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0062-2025·2024-10-23

    Monarch Balloon Angioplasty Syringes Recalled Due to Sterile Barrier Defects

    Merit Medical Systems is recalling 432 Monarch 30 ATM syringes used in balloon angioplasty procedures due to manufacturing defects creating holes in the sterile Tyvek barrier.

    Product
    Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used
    Category
    Medical Device
    Distribution
    Distributed nationwide