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.

17776–17800 of 27263

  • HighFDA (Devices)·Z-1291-2023·2023-04-05

    Alcon Custom Pak Surgical Procedure Packs Recalled for Incomplete Seals

    Alcon Research is recalling 1,035 Custom Pak Surgical Procedure Packs with incomplete seals that affect sterility. These packs were distributed to surgical facilities in 14 US states.

    Product
    Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SURGI CARE 18382-03 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 8685-21 CATARACT PACK EYE SURGICAL CNTR OF AR 19451-02 DR ROESKE PACK INLAND VALLEY SURGERY CTR 1913
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Food)·F-0664-2023·2023-04-05

    Seasoned Vegetables Recalled for Undeclared Soy and Wheat Allergens

    Lemonland Food Corp is recalling Seasoned Vegetables (Cirsium Setidens) distributed in Washington due to undeclared soy and wheat allergens. Consumers with soy or wheat allergies should not consume this product.

    Product
    Seasoned Vegetables (Cirsium Setidens) distributed in un-labeled plastic containers 6oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    0 states
  • 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
  • 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 (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 (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
    0 states
  • ModerateFDA (Drugs)·D-0482-2023·2023-04-05

    Glimepiride tablet recall due to manufacturing practice deviations

    Direct Rx is recalling Glimepiride 4 mg tablets nationwide due to manufacturing process deviations. The recall is voluntary and affects specific lots of 30-count and 90-count bottles.

    Product
    Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0250-30; b) 90-count bottle, NDC 61919-0250-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1295-2023·2023-04-05

    PCRopsis BCSNano nucleic acid extraction kit recalled for misleading label statements

    Entopsis, Inc. is recalling PCRopsis BCSNano nucleic acid extraction kits due to misleading statements on the product label. The affected lot (Lot 3, expiring 11/2023) was distributed nationwide and internationally.

    Product
    PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1307-2023·2023-04-05

    ACL ELITE PRO analyzer test definition removal for Anti-Xa reagent

    Instrumentation Laboratory is removing test definitions for HemosIL Liquid Anti-Xa reagent from ACL Elite and Elite Pro analyzers with Serial Number 16053360R and prior. The recall affects 33 units distributed worldwide.

    Product
    ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0666-2023·2023-04-05

    Seasoned Garlic with Salt and Vinegar recalled for ingredient statement update

    Lemonland Food Corp recalled seasoned garlic distributed in Washington after providing consignees with an updated ingredients statement.

    Product
    Seasoned Garlic with Salt and Vinegar distributed in un-labeled plastic containers 6oz, 8oz, and 12oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0480-2023·2023-04-05

    Drug Recall: Glimepiride Tablets Due to Manufacturing Deviations

    Direct Rx is recalling Glimepiride, USP, 1 mg Tablets nationwide due to cGMP deviations. The firm-initiated recall impacts both 30-count and 90-count bottles distributed across the USA.

    Product
    Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC 61919-0723-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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 (Devices)·Z-1299-2023·2023-04-05

    PCR Reagent Recalled for Misleading Label Statements

    Entopsis, Inc. is recalling 397 units of PCRopsis Reagent RVD with RVD Enhancer due to misleading label statements. The affected products were distributed nationwide and internationally.

    Product
    PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025; c) 100 mL, REF 78336100; Extraction-free PCR from saliva, urine, &swab specimens in transport medium, nucleic acid extraction from a variety of biological samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0478-2023·2023-04-05

    Prescription Drug Ropinirole 0.25 mg Tablets Recalled for Manufacturing Deviations

    Direct Rx is recalling Ropinirole, USP, 0.25 mg tablets (NDC 72189-0364-30, Lot 21JU2210) nationwide due to Good Manufacturing Practice (cGMP) deviations. The firm voluntarily initiated this recall on March 13, 2023.

    Product
    Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1297-2023·2023-04-05

    PCRopsis Activator nucleic acid extraction kits recalled for misleading labels

    Entopsis, Inc. is recalling PCRopsis Activator nucleic acid extraction kits due to misleading label statements. The products were distributed nationwide and internationally.

    Product
    PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a variety of biological samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (Drugs)·D-0476-2023·2023-04-05

    Drug Recall: Montelukast Sodium Tablets Due to Manufacturing Deviations

    Direct Rx is recalling Montelukast Sodium 10 mg tablets nationwide due to manufacturing process deviations. The voluntary recall affects approximately 508 bottles distributed across the United States.

    Product
    Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 61919-0009-90; 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
    0 states
  • ModerateFDA (Drugs)·D-0484-2023·2023-04-05

    Drug Manufacturer Recalls Simvastatin Tablets for Manufacturing Deviations

    Direct Rx recalled Simvastatin 10 mg tablets nationwide due to manufacturing process deviations discovered during production. No illnesses or injuries have been reported.

    Product
    Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle, NDC61919-0688-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0486-2023·2023-04-05

    Simvastatin Tablets Recalled Nationwide Over Manufacturing Practice Deviations

    Direct Rx is recalling 269 bottles of Simvastatin 40 mg nationwide due to Good Manufacturing Practice deviations. No adverse events have been reported. Consult your healthcare provider before changing your medication.

    Product
    Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1308-2023·2023-04-05

    MicroVue C1-Inhibitor Plus EIA kits recalled for potential test failure

    Quidel is recalling specific lots of MicroVue C1-Inhibitor Plus EIA test kits that may produce low optical density values and invalid test results.

    Product
    MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing Coated Strips, REF: 4634, with an ID number of 2200 or above
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0485-2023·2023-04-05

    Simvastatin 20mg Tablets Recalled for Manufacturing Practice Deviations

    Direct Rx recalled Simvastatin 20mg tablets nationwide due to manufacturing practice deviations. The voluntary recall affects bottles distributed across the United States.

    Product
    Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC 61919-0446-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    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
    0 states