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.

13751–13775 of 29188

  • SevereFDA (Drugs)·D-1113-2018·2018-08-29

    Hetero Labs Recalls Valsartan Tablets Due to Carcinogen Impurity

    Hetero Labs Limited is recalling Valsartan tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1114-2018·2018-08-29

    Hetero Labs Recalls Valsartan Tablets Due to Carcinogen Impurity

    Hetero Labs Limited is recalling Valsartan tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V567000·2018-08-28

    MAC Trailers Recalls 2019 Dump and Waste Trailers for Wheel Nut Defect

    MAC Trailer Mfg. is recalling 2019 Dump and Waste trailers because the wheel end nut locking device may not be properly installed, allowing the wheel end to separate from the axle.

    Product
    MAC TRAILERS — MAC TRAILERS WASTE TRAILER, DUMP TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E087000·2018-08-28

    Dexter D44 Trailer Axles Recalled for Potential Bearing Failure

    Dexter Axle is recalling D44 trailer axles with 4,400-pound capacity because missing inner bearing races can cause hub overheating or bearing failure.

    Product
    SUSPENSION:REAR:AXLE:NON-POWERED AXLE ASSEMBLY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·18762·2018-08-27

    Polaris Recalls 2018 RZR XP Turbo S Vehicles Due to ROPS Fracture Hazard

    Polaris is recalling about 1,300 model year 2018 RZR XP Turbo S recreational off-highway vehicles because the rollover protection structure can fracture during high-speed rollovers.

    Product
    Model year 2018 RZR XP Turbo S recreational off-highway vehicles (ROVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V565000·2018-08-27

    Fabform Recalls 2018 EPT Dump Trailers Due to Hinge Fracture Risk

    Fabform is recalling 2018 EPT dump trailers because welded hinges may fracture, causing the dump box to fall unexpectedly and increasing the risk of injury or death.

    Product
    FABFORM — FABFORM DUMP TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V564000·2018-08-27

    Jayco Recalls 2015-2017 Redhawk Motorhomes Due to Fire Risk

    Jayco is recalling 2015-2017 Redhawk motorhomes because liquid leakage into the driver's power window switch can cause corrosion and increase the risk of a fire.

    Product
    JAYCO — JAYCO REDHAWK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·PHA-08242018-01·2018-08-24

    USDA Issues Public Health Alert for Empire Kosher Raw Chicken Due to Salmonella

    USDA FSIS issued a public health alert for Empire Kosher raw chicken products sold from September 2017 to June 2018 due to a link with a Salmonella outbreak.

    Product
    FSIS Issues Public Health Alert for Empire Kosher Poultry, Inc. Raw Chicken Products due to Possible Salmonella Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V559000·2018-08-23

    REV Recalls 2018-2019 Motorhomes Due to Generator Exhaust Fire Risk

    REV Recreation Group is recalling 2018-2019 Fleetwood Pulse and Holiday Rambler Prodigy motorhomes because the generator exhaust pipe may contact the waste tank, increasing fire risk.

    Product
    HOLIDAY RAMBLER — HOLIDAY RAMBLER, FLEETWOOD PRODIGY, PULSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V556000·2018-08-23

    RAM 1500 Recall for Rear Differential Oil Level Defect

    Chrysler is recalling 2018-2019 RAM 1500 trucks because the rear differential may be underfilled, which could cause axle failure and increase crash risk.

    Product
    RAM — RAM 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V561000·2018-08-23

    Thomas Built Buses Saf-T-Liner C2 School Bus Seat Recall

    Daimler Trucks North America is recalling 2017-2019 Thomas Built Buses Saf-T-Liner C2 school buses because seat mounting feet may pull through the floor joint in a crash.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1085-2018·2018-08-22

    Ranier's Compounding Laboratory Recalls Morphine Sulf Inhalation Due to Sterility Concerns

    Ranier's Compounding Laboratory is recalling 60 vials of Morphine Sulf inhalation because practices at the firm may call into question the sterility of the product.

    Product
    Morphine Sulf inhalation, 5mg/3cc, 3cc per vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1090-2018·2018-08-22

    Ranier's P/P/P Injection Recalled for Sterility Assurance Concerns

    Ranier's Compounding Laboratory is recalling P/P/P Injection vials because practices at the firm may call into question the sterility of the products.

    Product
    P/P/P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.02/30/2 mg/mL, 5 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1077-2018·2018-08-22

    Lupin Recalls Lisinopril Tablets Due to Metal Contaminant

    Lupin Pharmaceuticals is recalling specific lots of Lisinopril tablets because a metal contaminant was found in one tablet.

    Product
    LISINOPRIL — LISINOPRIL (LISINOPRIL)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1096-2018·2018-08-22

    Northwind Recalls Valsartan HCTZ Tablets Due to Carcinogen Impurity

    Northwind Pharmaceuticals is recalling 43 bottles of Valsartan HCTZ 160/12.5mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-950-52
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1092-2018·2018-08-22

    Ranier's Compounding Laboratory Recalls Prostaglandin Injection Due to Sterility Concerns

    Ranier's Compounding Laboratory is recalling Pro/PA/PH/AT Injection in Pennsylvania due to a lack of assurance of sterility.

    Product
    PRO/PA/PH/AT 18mcg/1.8mg/ (Prostaglandin//Papaverine/Phentolamine/Atropine) Injection, 18mcg/1.8 mg/0.2 mg/0.02 mg/mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2824-2018·2018-08-22

    Sorin Platinium CRT-D Recall Due to Pacing and Sensing Loss

    Sorin CRM SAS is recalling 16 Platinium CRT-D devices because a hardware defect may cause loss of pacing and sensing, preventing the device from delivering necessary defibrillation.

    Product
    Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Drugs)·D-1087-2018·2018-08-22

    Ranier's Compounding Laboratory Recalls Vitamin D3 Injection Due to Sterility Concerns

    Ranier's Compounding Laboratory is recalling Vitamin D3 Injection, 50,000 IU/mL, 4 mL vials, because practices at the firm may call into question the sterility of the product.

    Product
    Vitamin D3 Injection, 50,000 IU/mL, 4 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2811-2018·2018-08-22

    ICU Medical Recalls Smallbore I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of specific smallbore I.V. administration sets because they may leak or separate at the manifold connection.

    Product
    61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 1.2 Micron Filter, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Rotating Luer, 2 Ext.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Drugs)·D-1088-2018·2018-08-22

    Ranier's Medroxprogesterone Ophthalmic Solution Recalled for Sterility Concerns

    Ranier's Compounding Laboratory is recalling Medroxprogesterone 1% Ophthalmic Solution due to a lack of assurance of sterility. The product was distributed in Pennsylvania.

    Product
    Medroxprogesterone 1% Ophthalmic Solution, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
    Category
    Drug
    Distribution
    1 state