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.

13101–13125 of 29186

  • SevereFDA (Drugs)·D-0308-2019·2018-12-19

    Teva Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity

    Teva Pharmaceuticals USA is recalling specific bottles of Amlodipine, Valsartan, and Hydrochlorothiazide tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA).

    Product
    Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7810-56) & 90-count bottles (NDC 0093-7810-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0330-2019·2018-12-19

    Mylan Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Mylan Laboratories is recalling Valsartan and Hydrochlorothiazide tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA) in the active pharmaceutical ingredient.

    Product
    VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0320-2019·2018-12-19

    Mylan Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Mylan is recalling Amlodipine and Valsartan tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA) in the active pharmaceutical ingredient.

    Product
    AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0332-2019·2018-12-19

    Mylan Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Mylan is recalling Valsartan and Hydrochlorothiazide tablets because FDA analysis found trace amounts of the impurity NDEA in the active ingredient.

    Product
    VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0300-2019·2018-12-19

    Westminster Irbesartan Tablets Recalled Due to NDEA Impurity

    Westminster Pharmaceuticals is recalling specific lots of Irbesartan tablets because FDA testing found traces of the NDEA impurity.

    Product
    Westminster Irbesartan Tablets, USP 75 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Westminster Pharmaceuticals, LLC. Olive Branch, MS 38654 a) 30 count bottle NDC 69367-119-01; b) 90 count bottle NDC 69367-119-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0315-2019·2018-12-19

    Mylan Recalls Valsartan Tablets Due to NDEA Impurity

    Mylan Pharmaceuticals is recalling Valsartan 40 mg tablets because FDA labs confirmed the presence of the impurity N-nitrosodiethylamine (NDEA).

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0324-2019·2018-12-19

    Mylan Recalls Valsartan Tablets Due to NDEA Impurity

    Mylan is recalling specific lots of Valsartan 40 mg tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA).

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0307-2019·2018-12-19

    Teva Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity

    Teva Pharmaceuticals USA is recalling specific lots of Amlodipine, Valsartan, and Hydrochlorothiazide tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA).

    Product
    Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7807-56) & 90-count bottles (NDC 0093-7807-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0303-2019·2018-12-19

    Teva Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Teva Pharmaceuticals USA is recalling Amlodipine and Valsartan Tablets 5 mg/160 mg because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).

    Product
    Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-7690-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0302-2019·2018-12-19

    Westminster Irbesartan Tablets Recalled Due to NDEA Impurity Traces

    Westminster Pharmaceuticals is recalling specific lots of Irbesartan Tablets because FDA testing found traces of NDEA impurity.

    Product
    Westminster Irbesartan Tablets, USP 300 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Westminster Pharmaceuticals, LLC. Olive Branch, MS 38654 a) 30 count bottle NDC 69367-121-01; b) 90 count bottle NDC 69367-121-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0317-2019·2018-12-19

    Mylan Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Mylan Pharmaceuticals is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because FDA labs confirmed the presence of the impurity N-nitrosodiethylamine (NDEA).

    Product
    VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0581-2019·2018-12-19

    Leoni Fiber Optics Recalls Sterile Laser Fibers Due to Broken Seals

    Leoni Fiber Optics is recalling sterile laser fiber assemblies distributed in Ohio because broken package seals may compromise sterility and increase infection risk.

    Product
    Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-ForTec Fiber SU-200-TRUE-RT Label Smartscope packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting…
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0331-2019·2018-12-19

    Mylan Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Mylan is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA).

    Product
    VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    1 state
  • SevereUSDA FSIS·123-2018·2018-12-18

    Russ Davis Wholesale Recalls Chicken Wrap Products Due to Undeclared Egg Allergen

    Russ Davis Wholesale is recalling ready-to-eat chicken Caesar wraps because they contain eggs, a known allergen, that is not declared on the label.

    Product
    Russ Davis Wholesale, Inc. — Russ Davis Wholesale, Inc. Recalls Chicken Wrap Products due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·18V894000·2018-12-18

    Ford Recalls F-Series Trucks Due to Block Heater Fire Risk

    Ford is recalling 410,289 F-Series trucks because water in the block heater cable can cause corrosion and a fire.

    Product
    FORD — FORD F-150, F-450, redundant F-350, redundant F-250
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V926000·2018-12-18

    Eldorado Buses Recalled for Back Seat Cushion Locking Defect

    Eldorado is recalling 2017-2018 Arrivo, Passport, and E-Z Rider Max BRT buses because back seat cushions may not stay locked in place during a crash.

    Product
    ELDORADO — ELDORADO ARRIVO, PASSPORT, E-Z RIDER MAX BRT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V893000·2018-12-17

    Audi Recalls 2018 A5 Sportback for Loose Front Suspension Fasteners

    Volkswagen is recalling 2018 Audi A5 Sportback vehicles because front suspension fasteners may not be sufficiently tightened, which could cause a front wheel to become loose.

    Product
    AUDI — AUDI A5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·122-2018·2018-12-15

    Mannarich Recalls Siluriformes Fish Products Lacking Import Inspection

    Mannarich Food, Inc. is recalling approximately 145,245 pounds of Siluriformes fish products that were imported from Malaysia without U.S. inspection.

    Product
    Mannarich Food, Inc. Recalls Siluriformes Products Produced without Benefit of Import Inspection
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V889000·2018-12-14

    Autocar Recalls 2019 Xpeditor Vehicles Due to Loose Driveline Bolts

    Autocar is recalling 2019 Xpeditor vehicles because universal joint strap bolts may not be properly tightened, which could cause the drive shaft to detach and increase crash risk.

    Product
    AUTOCAR — AUTOCAR XPEDITOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V888000·2018-12-13

    Toyota Recalls 2018-2019 Tacoma Vehicles Due to Brake Master Cylinder Defect

    Toyota is recalling 2018-2019 Tacoma vehicles because improper machining of the brake master cylinder may damage internal seals, potentially reducing brake performance and increasing crash risk.

    Product
    TOYOTA — TOYOTA TACOMA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V887000·2018-12-13

    Toyota Recalls Land Cruiser and Lexus LX 570 for Air Bag Deactivation Risk

    Toyota is recalling 2008-2019 Land Cruiser and Lexus LX 570 vehicles because a broken wire harness may deactivate front passenger air bags, increasing injury risk in crashes.

    Product
    TOYOTA — TOYOTA, LEXUS LAND CRUISER, LX570
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E115000·2018-12-13

    Lifeworks Recalls Heated Seat Cushions and Blankets Due to Fire Risk

    Lifeworks is recalling specific Armor All heated seat cushions and blankets sold at Meijer because they may overheat and melt, posing a fire and injury risk.

    Product
    EQUIPMENT:ELECTRICAL recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide