The Recall Desk

State

Vermont product recalls

20,364 recalls have nationwide distribution and so reach Vermont. 0 additional recalls listed Vermont specifically in their distribution scope.

About recalls in Vermont

Most US product recalls have nationwide distribution — the manufacturer ships into every state and the recall sweeps the same way. We include those in this listing because they affect Vermont consumers even though the source notice doesn’t name the state. State-specific recalls are usually for products with regional distribution (a regional dairy, a local store brand) or where the agency was able to narrow the affected shipments to specific destinations.

If you’re checking whether a recall affects your purchase, the recall detail page lists the exact production lot codes, UPCs, and best-by dates. Match those against your package — distribution scope is a starting filter, not the final answer.

13051–13075 of 20364

  • HighFDA (Drugs)·D-0862-2023·2023-06-07

    Pilocarpine Hydrochloride Ophthalmic Solution Recalled for Manufacturing Compliance Deviations

    The FDA has recalled all lots of Pilocarpine Hydrochloride Ophthalmic Solution 4% due to manufacturing process deviations. The distributor ceased operations and cannot complete required stability testing.

    Product
    Pilocarpine Hydrochloride Ophthalmic Solution, USP 4%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0843-2023·2023-06-07

    Fentanyl Citrate Injection Nationwide Recall Due to Manufacturing Compliance Deviations

    Akorn, Inc. is recalling all lots of Fentanyl Citrate Injection nationwide due to manufacturing compliance deviations. The company was unable to complete required stability studies after ceasing operations.

    Product
    Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL), Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1639-2023·2023-06-07

    Maquet QUADROX-i Adult Oxygenator recalled for packaging damage compromising sterile barrier

    Maquet Medical Systems is recalling QUADROX-i Adult Oxygenators due to potential packaging damage that may compromise sterile barriers, risking infection during cardiopulmonary bypass surgery.

    Product
    BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067829
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0820-2023·2023-06-07

    Levofloxacin Ophthalmic Solution Recalled Due to Manufacturing Practice Deviations

    Akorn, Inc. is recalling all lots of Levofloxacin Ophthalmic Solution 0.5% due to manufacturing practice deviations. The firm went out of business and could not continue required stability studies.

    Product
    Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0802-2023·2023-06-07

    Ephedrine Sulfate Injection Recalled Due to Incomplete Stability Studies

    Akorn, Inc. is recalling all lots of Ephedrine Sulfate Injection due to manufacturing compliance deviations; the firm was unable to complete required stability studies.

    Product
    Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Intravenous Use, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0775-2023·2023-06-07

    Cough Relief Medication Recalled for Non-Food Grade Lubricant Manufacturing Defect

    Denison Pharmaceuticals is recalling Safe tussin PM nighttime cough relief due to use of non-food grade lubricant during manufacturing. Consumers should stop use and consult a pharmacist.

    Product
    Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1638-2023·2023-06-07

    Cardiac Oxygenator QUADROX-i Adult Recalled for Sterile Barrier Packaging Defects

    Maquet is recalling QUADROX-i Adult cardiopulmonary bypass oxygenators (Models HMO 70000-USA and HMO 71000-USA) due to packaging defects including holes, cracks, and improper placement of accessories that may compromise sterility.

    Product
    QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 70000-USA 701067820 HMO 71000-USA 701067823
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0792-2023·2023-06-07

    Ciclopirox Topical Solution Recalled Due to Manufacturing Practice Violations

    Ciclopirox 8% topical solution (nail lacquer) is recalled nationwide. The manufacturer went out of business and could not complete required stability testing to ensure product safety.

    Product
    Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0812-2023·2023-06-07

    FDA Recalls IC-Green Injectable Drug: Manufacturing Deviations Prevent Stability Verification

    Akorn, Inc. recalled all lots of IC-Green injectable drug nationwide because the firm went out of business and could not complete stability studies required to verify manufacturing compliance.

    Product
    IC-Green (indocyanine green for injection, USP) 25 mg/10 mL Kit, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0858-2023·2023-06-07

    Calcitriol Injection 2 mcg/mL Recalled Due to CGMP Deviations by Akorn, Inc.

    Akorn recalled all lots of Calcitriol Injection 2 mcg/mL nationwide due to CGMP deviations and inability to complete stability studies after the firm went out of business.

    Product
    Calcitriol Injection 2 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1642-2023·2023-06-07

    Venous Hardshell Cardiotomy Reservoirs recalled for sterile packaging defects

    Maquet Medical Systems USA is recalling Venous Hardshell Cardiotomy Reservoirs for cardiopulmonary bypass due to sterile packaging defects. Exposure to non-sterile product could result in infection, sepsis, or ischemia.

    Product
    Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1648-2023·2023-06-07

    Cytrellis ellacor Dermal Micro-Coring System Recalled for Potential Scarring

    Cytrellis Biosystems is recalling 89 units of the ellacor System Gen 4 nationwide due to irregular core patterns that may cause prolonged healing, skin texture irregularities, or scarring.

    Product
    Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System intended for the treatment of moderate and severe wrinkles in the mid and lower face. Model #: Gen 4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1655-2023·2023-06-07

    QUADROX-i Pediatric Oxygenators Recalled for Packaging Sterility Defects

    QUADROX-i Pediatric Oxygenators used in cardiopulmonary bypass surgery are recalled for packaging defects that may compromise sterility, potentially causing inflammation, infection, sepsis, or ischemia.

    Product
    QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1635-2023·2023-06-07

    Oxygenator devices recalled due to packaging damage compromising sterile barrier

    Maquet Medical Systems USA recalls 15,880 QUADROX-iD oxygenators nationwide due to packaging damage that may compromise sterile barriers, potentially exposing patients to infection.

    Product
    BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1662-2023·2023-06-07

    QUADROX-iR Heart-Lung Oxygenator Recalled for Sterile Barrier Packaging Defect

    Maquet Medical is recalling QUADROX-iR oxygenators used in heart-lung bypass procedures due to potential pinholes in packaging that may compromise the sterile barrier, creating risk of serious infection.

    Product
    QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE coating BEQ-HMO 71100-USA 701067880 Adult with filter, with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0827-2023·2023-06-07

    Megestrol Acetate Oral Suspension Recalled for Incomplete Stability Studies

    Akorn recalled all lots of Megestrol Acetate Oral Suspension nationwide due to the firm's inability to complete required stability studies after ceasing operations.

    Product
    Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1634-2023·2023-06-07

    Cardiopulmonary bypass oxygenator recalled due to sterile barrier packaging defects

    Maquet Medical Systems USA is recalling 8,670 HMOD 70000-USA/QUADROX-iD Adult oxygenators used in cardiopulmonary bypass due to packaging defects that may compromise sterile barriers and expose devices to contamination.

    Product
    HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067840
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0838-2023·2023-06-07

    Promethazine HCl Oral Solution Recalled Due to Manufacturing Deviations

    Akorn, Inc. is recalling all lots of Promethazine HCl Oral Solution, USP, due to Current Good Manufacturing Practice deviations. The firm went out of business and cannot complete required stability studies.

    Product
    Promethazine HCl Oral Solution, USP, 6.25 mg/5mL, 473 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0840-2023·2023-06-07

    Rifampin Capsules Recalled Due to Incomplete Stability Studies

    Akorn, Inc. is recalling all lots of Rifampin Capsules USP 150 mg distributed nationwide due to manufacturing deviations. The company ceased business before completing required stability studies to verify the drug remains safe and effective throughout its shelf life.

    Product
    Rifampin Capsules USP, 150 mg, 30-count bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1644-2023·2023-06-07

    EarlyVue VS30 Vital Signs Monitor lacks calibration alarm, risking inaccurate CO2 readings

    Philips EarlyVue VS30 vital signs monitors lack a calibration alarm, potentially causing inaccurate CO2 measurements. This could prevent clinicians from detecting changes in patient condition.

    Product
    EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1653-2023·2023-06-07

    Knee replacement implant bearing inserts mislabeled with wrong catalog numbers

    Howmedica Osteonics recalled 24 TRIATHLON X3 tibial bearing inserts due to mislabeling, where units labeled with one catalog number may contain a different size. Medical facilities should discontinue use and contact the manufacturer.

    Product
    TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0859-2023·2023-06-07

    Akorn Midazolam Injection Recalled Due to Incomplete Stability Studies

    Akorn, Inc. is recalling all lots of Midazolam Injection nationwide due to manufacturing practice deviations. The company ceased operations and could not complete stability studies to verify the drug's safety and efficacy.

    Product
    Midazolam Injection, USP, 50 mg/10mL (5mg/mL), For Intramuscular or Intravenous Use Only, 10 mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0825-2023·2023-06-07

    Lorazepam Injection Recalled Due to Manufacturing Control Deviations

    Akorn, Inc. is recalling all lots of Lorazepam Injection, USP 2 mg/mL due to CGMP deviations. The firm ceased operations and could not continue required stability studies.

    Product
    Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1657-2023·2023-06-07

    QUADROX-i Small Adult Oxygenator Recalled Due to Packaging Sterile Barrier Defect

    Maquet Medical Systems USA is recalling 1,784 QUADROX-i Small Adult Oxygenators used in heart bypass surgery because product packaging may contain tiny pinholes that compromise sterile integrity, potentially allowing non-sterile exposure.

    Product
    QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. BEQ-HMO 50000-USA 701067905 HMO 50000-USA 701067891 HMO 51000-USA 701067895
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0846-2023·2023-06-07

    Akorn Recalls All Lots of Sodium DIURIL Injectable Due to CGMP Deviations

    Akorn Operating Company recalls all lots of Sodium DIURIL (chlorothiazide sodium) 0.5g/vial due to Current Good Manufacturing Practice deviations. The manufacturer was unable to complete required stability studies after the firm ceased operations.

    Product
    Sodium DIURIL (chlorothiazide sodium), 0.5g/vial, Single-dose vial Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide