The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

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.

26201–26225 of 32215

  • SevereFDA (Drugs)·D-755-2014·2014-01-29

    Novartis Recalls Theraflu Flu and Chest Congestion Powder Packets

    Novartis Consumer Health is recalling Theraflu Flu & Chest Congestion powder packets because they may contain foreign substances.

    Product
    Theraflu Flu & Chest Congestion (acetaminophen 1000 mg and guaifenesin 400 mg) powder packets, Natural Citrus flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0043-0483-06, UPC 3 0043-0483-06 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-947-2014·2014-01-29

    FDA Recalls Vitamin B Complex Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Vitamin B Complex tablets that may have been mislabeled as Cinacalcet HCl. The repacked drugs were distributed in four western states.

    Product
    VITAMIN B COMPLEX W/C, Tablet, 0 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536730001.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-944-2014·2014-01-29

    Aidapak Recalls Niacin TR Tablets Due to Potential Labeling Error

    Aidapak Services, LLC is recalling Niacin TR 750 mg tablets because they may have been mislabeled as Nortriptyline HCL 50 mg capsules.

    Product
    NIACIN TR, Tablet, 750 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00536703301.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-832-2014·2014-01-29

    FDA Recalls Sotalol HCL Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Sotalol HCL 120 mg tablets because they may have been mislabeled as Neomycin Sulfate 500 mg tablets.

    Product
    SOTALOL HCL, Tablet, 120 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093106001.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-954-2014·2014-01-29

    FDA Recalls Bromocriptine Mesylate Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 2.5 mg Bromocriptine Mesylate tablets because they may have been mislabeled as Benazepril HCl or Thioridazine HCl.

    Product
    BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00574010603.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0812-2014·2014-01-29

    Vital Signs Anesthesia Circuits Recalled Due to Occlusion Risk

    Vital Signs Colorado Inc. is recalling anesthesia and ventilator circuits where a blue port cap may be attached, causing gas flow occlusion.

    Product
    Vital Signs Anesthesia Circuits The Ventilator Circuit is intended for use as an interface between a ventilator dependent patient and a ventilator. The Anesthesia Circuit is intended to administer medical gases to a patient during anesthesia. The CPAP Circuit is intended to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-919-2014·2014-01-29

    Aidapak Recalls Digoxin Tablets Due to Potential Label Mixup

    Aidapak Services is recalling Digoxin 125 mcg tablets because they may have been mislabeled as Cholecalciferol/Calcium/Phosphorus tablets.

    Product
    DIGOXIN, Tablet, 125 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00527132401.
    Category
    Drug
    Distribution
    4 states
  • SevereNHTSA·14V027000·2014-01-29

    Kenworth T660 and T680 Recalled for Incorrect Parking Brake Placement

    PACCAR is recalling 2013-2014 Kenworth T660 and T680 trucks because the parking brake is incorrectly placed on the non-driven rear axle, increasing the risk of the vehicle rolling away.

    Product
    KENWORTH — KENWORTH T660, T680
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0780-2014·2014-01-29

    Elekta XiO RTP System Recalled for Dose Calculation Error

    Elekta is recalling 13 XiO RTP Systems because a software error prevents dose recalculation when proton spot beam fractions are changed.

    Product
    XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two or three-dimensional…
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Drugs)·D-1018-2014·2014-01-29

    Aidapak Recalls Ascorbic Acid Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 250 mg Ascorbic Acid tablets because they may have been mislabeled as other prescription or over-the-counter drugs.

    Product
    ASCORBIC ACID, Tablet, 250 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904052260.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-928-2014·2014-01-29

    Aidapak Recalls Aspirin Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling 325 mg aspirin tablets because they may have been mislabeled as other prescription medications.

    Product
    ASPIRIN, Tablet, 325 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536330501.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-824-2014·2014-01-29

    FDA Recalls Diltiazem Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Diltiazem HCL 120 mg tablets that may have been mislabeled as Nicotine Polacrilex 2 mg lozenges.

    Product
    DILTIAZEM HCL, Tablet, 120 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093032101.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-938-2014·2014-01-29

    Aidapak Recalls Multivitamin Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling multivitamin tablets that may have been mislabeled as sitagliptin or loratadine. The FDA classifies this as a Class II recall.

    Product
    MULTIVITAMIN/MULTIMINERAL, Tablet, 0 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536406001.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-937-2014·2014-01-29

    Aidapak Recalls Cholecalciferol Capsules Due to Potential Label Mixup

    Aidapak Services is recalling 18,282 Cholecalciferol capsules because they may have been mislabeled as other drugs, including Doxycycline and Lamotrigine.

    Product
    CHOLECALCIFEROL, Capsule, 2000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536379001.
    Category
    Drug
    Distribution
    4 states
  • SevereNHTSA·14V020000·2014-01-28

    Spartan MM Motorhome Chassis Recalled for Sway Bar End Link Defect

    Spartan Motors is recalling 2010-2014 MM motorhome chassis due to a front suspension design that may cause sway bar end links to break, increasing crash risk.

    Product
    SPARTAN — SPARTAN MM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V018000·2014-01-27

    Starcraft Transit Buses Recalled for Alternator Harness Pinch Risk

    Starcraft is recalling 2010-2013 transit buses because a pinched alternator harness could cause vehicle stalling or a fire.

    Product
    STARCRAFT — STARCRAFT STARQUEST, XPRESS, ULTRASTAR, STARLITE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V021000·2014-01-27

    Trails West RPM Trailers Recalled for Furnace Fire Risk

    Trails West is recalling 2010-2014 RPM trailers due to a furnace defect that may cause melting and fire.

    Product
    TRAILS WEST — TRAILS WEST RPM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V019000·2014-01-27

    Turtle Top Recalls Ford-Based Transit Buses Due to Electrical Fire Risk

    Turtle Top is recalling 453 Ford-based transit buses because a pinched alternator harness could cause a short circuit, fire, or vehicle stall.

    Product
    TURTLE TOP — TURTLE TOP FORD VAN TERRA, FORD LIMO COACH, FORD ODYSSEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V014000·2014-01-24

    PACCAR Recalls 2012-2014 Kenworth and Peterbilt Trucks for Fire Risk

    PACCAR is recalling 2012-2014 Kenworth K300 and Peterbilt 210/220 trucks because a battery component may conduct electricity when hot, increasing fire risk.

    Product
    PETERBILT — PETERBILT, KENWORTH 210, K300, MODEL 220
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14T001000·2014-01-23

    Lionshead Recalls 39,569 Vail Sport ST LH 99 Trailer Tires

    Lionshead Specialty Tire & Wheel LLC is recalling 39,569 Vail Sport ST LH 99 trailer tires because they may fail or unseat from rims, increasing crash risk.

    Product
    TIRES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·14086·2014-01-23

    Matrix Fitness Ascent Trainers and Ellipticals Recalled Due to Fire Hazard

    Johnson Health Tech is recalling about 2,800 Matrix Fitness Ascent Trainers and Ellipticals sold to commercial facilities due to a fire hazard from moisture buildup in the power socket.

    Product
    Ascent Trainer® by Matrix and Matrix Fitness Elliptical
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V011000·2014-01-23

    Corn Pro Deckover Flatbed Trailer Recall for Tail Pivot Box Failure

    Cornelius Manufacturing is recalling 2012-2014 Corn Pro Deckover Flatbed Trailers because welded boxes allowing the tail to pivot may fail, increasing accident risk.

    Product
    CORN PRO — CORN PRO DECKOVER FLATBED TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·14089·2014-01-23

    Flushmate III Pressure-Assist Flushing System Recalled for Bursting Hazard

    Flushmate is recalling about 351,000 Flushmate III Pressure-Assist Flushing Systems sold in the U.S. because the units can burst, posing impact and laceration hazards.

    Product
    Flushmate® III Pressure-Assist Flushing System
    Category
    Consumer Product
    Distribution
    Distributed nationwide