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.

19526–19550 of 88183

  • ModerateFDA (Devices)·Z-1301-2023·2023-04-05

    PCRopsis Support Medical Device Recall Due to Misleading Label Statements

    Entopsis, Inc. is recalling PCRopsis Support nucleic acid extraction reagents due to misleading statements on product labels. No illnesses or injuries have been reported.

    Product
    PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 787003; Improves the functionality of PCRopsis regents for select applications; nucleic acid extraction from a variety of biological samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0483-2023·2023-04-05

    Drug Recall: Simvastatin 5 mg tablets due to manufacturing compliance violations

    Direct Rx is recalling 51 bottles of Simvastatin 5 mg tablets nationwide due to Good Manufacturing Practice deviations. The recall is voluntary and was initiated in March 2023.

    Product
    Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0679-2023·2023-04-05

    Cucumber Pickle Recalled for Ingredients Statement Correction

    Lemonland Food Corp is recalling Cucumber Pickle in 8-ounce containers distributed in Washington from February 16–23, 2023, due to an incorrect ingredients statement. The firm provided an updated statement to consignees.

    Product
    Cucumber Pickle distributed in un-labeled plastic containers 8oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0671-2023·2023-04-05

    Rakkyo (scallions) recalled due to incorrect ingredients statement

    Lemonland Food Corp recalled Rakkyo (scallions) distributed in Washington because the ingredients statement label required correction. The product contains no allergens.

    Product
    Rakkyo (scallions) distributed in un-labeled plastic containers 8oz and/or 12oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0477-2023·2023-04-05

    Finasteride Tablets Recalled Nationwide for Manufacturing Practice Deviations

    Direct Rx is recalling 19 bottles of Finasteride 5 mg Tablets nationwide due to cGMP deviations. The firm initiated this recall voluntarily.

    Product
    Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By: Direct Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1298-2023·2023-04-05

    Medical device lysis beads recalled for misleading label statements

    Entopsis recalls PCRopsis Lysis Beads (363 units) due to misleading label statements on the product packaging. The affected product was distributed nationwide and to Canada, UK, Portugal, Spain, Germany, Brazil, Denmark, South Korea, Colombia, and Lithuania.

    Product
    PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF 5970025; e) 1000 kilogram, REF 5971000; coated beads that facilitate lysis of microorganisms; nucleic acid extraction from a variety of biological samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1317-2023·2023-04-05

    Shoulder Glenoid Prosthesis Implant Manufactured Without Tantalum Markers

    A shoulder glenoid prosthesis implant (SMR TT Hybrid Std - Peg S) was manufactured without tantalum markers that aid in radiographic visualization. While alternative assessment methods using joint space, peg position, and cement observation remain available, the missing markers limit direct imaging capabilities.

    Product
    SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1305-2023·2023-04-05

    ACL ELITE PRO-Analyzer: HemosIL Liquid Anti-Xa test definition removed

    Instrumentation Laboratory is removing the HemosIL Liquid Anti-Xa test definition from ACL ELITE/Elite Pro analyzers used in clinical hemostasis laboratories. No illnesses or injuries have been reported.

    Product
    ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1296-2023·2023-04-05

    PCRopsis Reagent Buccal Kit Recalled for Misleading Label Statements

    Entopsis, Inc. is recalling PCRopsis Reagent Buccal (REF 282001), an extraction-free PCR reagent kit, due to misleading label statements on the product labeling.

    Product
    PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swabs (no transport medium) ,nucleic acid extraction from a variety of biological samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0632-2023·2023-03-29

    IWATSUKASEIKA Soybean Flavor Snack Recalled for Undeclared Wheat Allergen

    DAISO CALIFORNIA WAREHOUSE is recalling IWATSUKASEIKA Soybean Flavor snacks because wheat was not declared on the label. Consumers with wheat allergies should not consume this product.

    Product
    IWATSUKASEIKA Soybean flavor 72g -21pieces UPC: 4901037131919 Made in Japan
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-0635-2023·2023-03-29

    YAMANAKAFOODS Salted Hijiki Seaweed 20g Recalled for Undeclared Wheat Allergen

    YAMANAKAFOODS Seasoning - Salted Hijiki Seaweed (20g) is being recalled because the label does not disclose wheat as an ingredient. Consumers with wheat allergies are at risk of allergic reaction.

    Product
    YAMANAKAFOODS Seasoning - Salted Hijiki Seaweed 20g UPC: 4902378014053 Made in Japan
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0628-2023·2023-03-29

    MEITO Lemon Tea Recalled Due to Undeclared Milk Allergen

    MEITO Lemon Tea 4-pack is being recalled because milk allergen was not declared on the label. Consumers with milk allergies should not consume this product.

    Product
    MEITO Lemon Tea 4 Pack UPC: 4902757413507 Made in Japan
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0638-2023·2023-03-29

    ITOSEIKA Chocolate Chip Cookies Recalled for Undeclared Milk Allergen

    ITOSEIKA chocolate chip cookies are being recalled due to undeclared milk allergen on the label. Consumers with milk allergies should not consume this product.

    Product
    ITOSEIKA Chocolate chip cookies 10pieces UPC: 4901050111400 Made in Japan
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0631-2023·2023-03-29

    Rice Crackers Recalled Due to Undeclared Wheat Allergen

    DAISO CALIFORNIA WAREHOUSE is recalling IWATSUKASEIKA Ajishirabe Rice Crackers because the label fails to declare wheat. Wheat is a major allergen that can cause severe allergic reactions in sensitive individuals.

    Product
    IWATSUKASEIKA Ajishirabe Rice Crackers UPC: 4901037117746 Made in Japan
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0643-2023·2023-03-29

    Pistachio wasabi snack recalled for undeclared soy allergen

    SENNARIDO Green Snack Pistachio-Wasabi Flavor (90g) is recalled because soy is not declared on the label. Approximately 10,986 units were distributed across California, Washington, Nevada, Texas, New York, New Jersey, and Canada.

    Product
    SENNARIDO Green Snack Pistachio -Wasabi Flavor 90g UPC: 4974120431715 Made in Japan
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0633-2023·2023-03-29

    Powdered lemon tea recalled for undeclared milk allergen

    MEITO An extra Stick Powdered Lemon Tea is recalled because the product contains milk that is not declared on the label. Consumers with milk allergies who have purchased this product should not consume it.

    Product
    MEITO An extra Stick Powdered Lemon Tea 5packs UPC: 4902757442804 Made in Japan
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0630-2023·2023-03-29

    Sesame sauce recalled due to undeclared wheat allergen

    Shinsei Additive Free Sesame Sauce is being recalled because wheat allergen was not declared on the product label. Consumers with wheat allergies who consume this product may experience allergic reaction.

    Product
    Shinsei Additive Free Sesame Sauce 22g UPC: 4901665004616 Made in Japan
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0640-2023·2023-03-29

    SENNARIDO pistachio snack recalled for undeclared soy allergen

    DAISO CALIFORNIA WAREHOUSE is recalling SENNARIDO Green Snack Pistachio 90g because the product contains undeclared soy, a major food allergen that poses allergic reaction risk to sensitive consumers.

    Product
    SENNARIDO Green Snack Pistachio 90g UPC: 4974120413421 Made in Japan
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0488-2023·2023-03-29

    Delsam Pharma Artificial Eye Ointment Recalled for Bacterial Contamination

    Delsam Pharma's Artificial Eye Ointment is being recalled for bacterial contamination in unopened tubes. FDA analysis found non-sterility defects in approximately 50,000 units.

    Product
    Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5 grams (1/8 oz.) tube, Distributed By: Delsam Pharma Lic, Bronx, Newyork 10469, NDC 72570 122 35, UPC 3 72570 12235 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0642-2023·2023-03-29

    Kurata Menzo Ramen Recalled for Undeclared Coconut Allergen

    DAISO CALIFORNIA WAREHOUSE is recalling Kurata Menzo Meatfree Tonkotsu Ramen Dry due to undeclared coconut on the label. Consumers with coconut allergies who consume this product may experience allergic reactions.

    Product
    Kurata Menzo Meatfree Tonkotsu Ramen Dry 2P 238.8g UPC: 4906436004932 Made in Japan
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0636-2023·2023-03-29

    Soft rice crackers recalled for undeclared coconut allergen

    DAISO CALIFORNIA WAREHOUSE is recalling 150YEN HIZATSUKI Soft rice crackers because the product contains coconut that was not declared on the label. Consumers with coconut allergies should not consume this product.

    Product
    150YEN HIZATSUKI Soft rice crackers sea lettuce soy sauce flavor UPC: 4902445210500 Made in Japan
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0634-2023·2023-03-29

    Coffee Candy Recalled for Undeclared Coconut Allergen

    Kanro Non sugar coffee candy is recalled because coconut was not declared on the label, posing a risk to consumers with coconut allergies.

    Product
    Kanro Non sugar coffee candy 40g UPC: 4901351013137 Made in Japan
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0699-2023·2023-03-29

    Sprouts Farmers Market Saltine Crackers recalled for potential peanut contamination

    Sprouts Farmers Market is recalling Saltine Crackers Sea Salt Tops due to potential peanut contamination. Approximately 1,050 cases were distributed in Arizona, California, and Georgia.

    Product
    Sprouts Farmers Market Saltine Crackers Sea Salt Tops NET WT 16 OZ (1 LB) 454g UPC 646670310164 packaged in slug wrapper in a cardboard carton, 12 packages per case
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1279-2023·2023-03-29

    Cardiosave IABP Pneumatic Interface Module Recalled for Performance Issue

    Datascope Corp. recalls the Cardiosave IABP Pneumatic Interface Module due to a Safety Disk performance issue that may reduce balloon inflation. Ten specific units with identified serial numbers are affected.

    Product
    Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model Number 0997-00-1178
    Category
    Medical Device
    Distribution
    0 states