The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

13276–13300 of 53086

  • HighFDA (Drugs)·D-0603-2023·2023-05-24

    Ampicillin and Sulbactam Injection Recalled Due to Sterility Assurance Concerns

    Xellia Pharmaceuticals is recalling Ampicillin and Sulbactam for Injection due to lack of assurance of sterility. Approximately 23,187 bottles were distributed nationwide; patients should consult their healthcare provider.

    Product
    Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-083-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0618-2023·2023-05-24

    Ceftriaxone for Injection Recalled for Lack of Sterility Assurance

    Xellia Pharmaceuticals is recalling 739,750 vials of Ceftriaxone for Injection, USP due to lack of assurance of sterility. All affected lots nationwide should not be used.

    Product
    Ceftriaxone for Injection, USP, 1 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-096-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0612-2023·2023-05-24

    Ceftriaxone Injectable Antibiotic Recalled Due to Sterility Assurance Failure

    Ceftriaxone for Injection is being recalled due to lack of assurance of sterility. The recall affects 65,950 vials distributed nationwide in the United States.

    Product
    Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-212-42
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0635-2023·2023-05-24

    Apollo Care Ketamine Injection Recalled Due to Sterility Assurance Defect

    Apollo Care is recalling Ketamine Injection single-use syringes (2,040 units) distributed in Missouri due to lack of assurance of sterility. Patients should consult their healthcare provider if affected.

    Product
    Ketamine Injection, 50 mg per 5 mL (10 mg/mL), Single-Use Syringe, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-050-05
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0620-2023·2023-05-24

    Ceftriaxone Injection Recalled Over Sterility Assurance Defect

    Astral SteriTech is recalling Ceftriaxone for Injection due to lack of assurance of sterility. The Class II recall affects approximately 7,940 pharmacy bulk packages distributed nationwide.

    Product
    Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-098-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0644-2023·2023-05-24

    Norepinephrine injectable recalled for lack of sterility assurance

    Apollo Care is recalling Norepinephrine 4 mg dextrose injection (682 bags) due to lack of assurance of sterility. Distribution was limited to Missouri.

    Product
    Norepinephrine 4 mg added to 250 mL of 5% Dextrose Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-500-25
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0577-2023·2023-05-24

    Ketotifen Fumarate eye drops recalled due to manufacturing quality control deviations

    RemedyRepack Inc. is recalling Ketotifen Fumarate eye drops (NDC 70518-1142-00) distributed in Pennsylvania due to the manufacturer's discontinuation of quality assurance programs, which may have affected product identity, strength, and purity.

    Product
    Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1142-00; Source NDC # 17477-0717-10;
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0637-2023·2023-05-24

    FDA Recalls Apollo Care Norepinephrine Injections Due to Sterility Assurance Failure

    Apollo Care, LLC is recalling 1,617 bags of Norepinephrine 8 mg intravenous injection distributed in Missouri due to lack of assurance that the product meets sterility requirements.

    Product
    Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-550-25
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1595-2023·2023-05-24

    Steris Reliance Vision Washer/Disinfector Recalled for Fire and Smoke Risk

    Steris is recalling 322 Reliance Vision Multi-Chamber Washer/Disinfectors because an electrical contactor malfunction could cause heating elements to overheat and produce smoke or fire.

    Product
    Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1584-2023·2023-05-24

    Spectral CT X-Ray System Foot Switch May Entrap Operator's Foot

    The Spectral CT 7500 foot switch unload pedal may entrap an operator's foot, risking injuries including fracture and dislocation. Philips is recalling 92 units with worldwide distribution.

    Product
    Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V359000·2023-05-19

    2023 Forest River Salem and Wildwood Travel Trailer Propane System Recall

    Forest River is recalling 2023 Salem and Wildwood travel trailers due to missing thread sealant on furnace fittings. The defect can cause propane gas leaks, increasing fire risk.

    Product
    FOREST RIVER — FOREST RIVER SALEM, WILDWOOD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V358000·2023-05-18

    2021-2023 Ford Bronco Seat Belt Latch Accessibility Recall

    Ford is recalling certain 2021-2023 Bronco vehicles because first-row seat belt latch plates may be difficult to access, potentially preventing occupants from wearing their seat belts and increasing crash injury risk.

    Product
    FORD — FORD BRONCO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V356000·2023-05-18

    Gillig Recalls 2022 Low Floor Buses Due to Electrical Fire Risk

    Gillig is recalling 2022 Low Floor CNG transit buses because an electrical failure in the fuse box may cause a short-circuit, increasing the risk of a fire.

    Product
    GILLIG — GILLIG LOW FLOOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V357000·2023-05-18

    Altec Aerial Devices Recalled for Water Intrusion Fire Risk

    Altec is recalling 2021-2023 aerial devices, digger derricks, and related equipment because water can leak into strobe lights, causing electrical short-circuits that increase fire risk. No injuries have been reported.

    Product
    ALTEC — ALTEC AERIAL DEVICE, DIGGER DERRICK, EFFER CRANE, SERVICE BODY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V352000·2023-05-18

    Jeep Grand Cherokee Steering Column Intermediate Shaft Defect Recall

    Certain 2021–2023 Jeep Grand Cherokee models have an incorrectly assembled steering column intermediate shaft that may disconnect and cause loss of steering control, increasing crash risk. Chrysler is offering free inspection and replacement.

    Product
    JEEP — JEEP GRAND CHEROKEE, GRAND CHEROKEE 4XE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23203·2023-05-18

    PhysiciansCare Allergy and Cold and Cough Tablets Lack Child-Resistant Packaging

    Acme United is recalling PhysiciansCare Allergy, Allergy Plus, and Cold and Cough tablets sold on Amazon.com from January 2021 through August 2022 because the packaging is not child resistant, risking poisoning if young children swallow the contents.

    Product
    PhysiciansCare Allergy, Allergy Plus and Cold and Cough
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·23V355000·2023-05-18

    VinFast Recalls 2023 VF 8 Vehicles Due to Display Software Error

    VinFast is recalling 2023 VF 8 vehicles because a software error may cause the main display to go blank, hiding critical safety information like the speedometer.

    Product
    VINFAST — VINFAST VF 8
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V353000·2023-05-18

    Navistar International trucks recalled for inadequate back-up light visibility

    Navistar is recalling certain International trucks (2000-2024 model years) for inadequate back-up light visibility when reversing. Low visibility may not alert other drivers, increasing crash risk. Dealers will replace rear stop/turn signal lights free of charge.

    Product
    INTERNATIONAL — INTERNATIONAL MV, 9400I, 9100I, 9200I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23759·2023-05-18

    Ventura Adult Bike Helmets Recalled for Risk of Head Injury

    Messingschlager USA LLC (Cycle Force) is recalling about 1,750 Ventura Adult Bike Helmets because they do not meet federal safety standards for positional stability and can fail to protect in a crash. No injuries have been reported.

    Product
    Ventura Adult Bike Helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V351000·2023-05-18

    Fleetwood, Holiday Rambler Motorhomes Recalled for Damaged Trailer Hitch

    REV Recreation Group is recalling 2020-2024 Fleetwood Bounder, Holiday Rambler Vacationer, and select Fleetwood Southwind motorhomes. The trailer hitch may become damaged due to stress or overloading, potentially causing the towed vehicle to separate.

    Product
    HOLIDAY RAMBLER — HOLIDAY RAMBLER, FLEETWOOD VACATIONER, BOUNDER, SOUTHWIND
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1564-2023·2023-05-17

    Bard Mission Biopsy Instrument Kit cannula and needle incompatibility

    Bard Mission Disposable Biopsy Instrument Kit has an incompatibility defect where the cannula is oversized relative to the needle, preventing proper insertion and tissue access. This could cause procedure delays and insufficient tissue collection.

    Product
    Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1577-2023·2023-05-17

    STA Compact Max analyzer firmware bug causes inaccurate test results

    A firmware bug in Diagnostica Stago's STA Compact Max analyzer causes intermittent shortened coagulation times and frequent technical errors that produce inaccurate lab test results. Five units were distributed to clinical laboratories nationwide.

    Product
    STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0830-2023·2023-05-17

    Ziyad Cinnamon Powder Recalled for Elevated Lead Levels

    ZB Importing LLC is recalling Ziyad cinnamon powder (4.5 oz jars) from lot 21321G2 due to elevated lead levels. The recall affects 3,456 units distributed across multiple U.S. states and territories.

    Product
    Ziyad cinnamon powder, retail 4.5oz plastic jar with shaker cap UPC 074265007432, 12 retail jars per wholesale case
    Category
    Food
    Distribution
    35 states