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.

13076–13100 of 29186

  • SevereFDA (Food)·F-0735-2019·2018-12-19

    K & T Oriental Imports Recalls Salmon Fillets for Listeria Risk

    K & T Oriental Imports Inc. is recalling 3,094 kgs of salmon fillets in Texas and New Mexico due to potential Listeria monocytogenes contamination.

    Product
    Salmon fillets packaged inside Styrofoam boxes fully surrounded and covered in ice, which were stored inside a temperature controlled cooler
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0301-2019·2018-12-19

    Westminster Irbesartan Tablets Recalled Due to NDEA Impurity Traces

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

    Product
    Westminster Irbesartan Tablets, USP 150 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 69367-120-01; b) 90 count bottle NDC 69367-120-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0305-2019·2018-12-19

    Teva Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Teva Pharmaceuticals USA is recalling specific lots of Amlodipine and Valsartan Tablets 5 mg/320 mg because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).

    Product
    Amlodipine and Valsartan Tablets 5 mg/320 mg, (a) 30-count bottles (NDC 0093-7692-56) & 90-count bottles (NDC 0093-7692-98), 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-0327-2019·2018-12-19

    Mylan Recalls Valsartan Tablets Due to NDEA Impurity

    Mylan is recalling Valsartan 320 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-0318-2019·2018-12-19

    Mylan Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Mylan Pharmaceuticals is recalling Amlodipine and Valsartan tablets because FDA testing found the impurity N-nitrosodiethylamine (NDEA) in the active ingredient.

    Product
    AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0312-2019·2018-12-19

    Mylan Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Mylan Pharmaceuticals is recalling Amlodipine and Valsartan tablets because FDA testing confirmed the presence of the impurity N-nitrosodiethylamine (NDEA).

    Product
    AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0316-2019·2018-12-19

    Mylan Recalls Valsartan Tablets Due to NDEA Impurity

    Mylan Pharmaceuticals is recalling specific lots of Valsartan 320 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-0322-2019·2018-12-19

    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 ingredient.

    Product
    AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·18V907000·2018-12-19

    Kia Recalls Optima, Sportage, and Sorento for Fuel Leak Risk

    Kia is recalling 2011-2018 Optima, Sportage, and Sorento vehicles that had previous engine replacements due to a potential fuel pipe defect that could cause a leak and fire.

    Product
    KIA — KIA OPTIMA, SPORTAGE, SORENTO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0328-2019·2018-12-19

    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 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-0304-2019·2018-12-19

    Teva Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

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

    Product
    Amlodipine and Valsartan Tablets 10 mg/160 mg, (a) 30-count bottles (NDC 0093-7961-56) & 90-count bottles (NDC 0093-7691-98), 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-0329-2019·2018-12-19

    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 N-nitrosodiethylamine (NDEA) in the active ingredient.

    Product
    VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0321-2019·2018-12-19

    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 NDEA in the active ingredient.

    Product
    AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0326-2019·2018-12-19

    Mylan Recalls Valsartan Tablets Due to NDEA Impurity

    Mylan is recalling Valsartan tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA). The product was distributed throughout the United States.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0311-2019·2018-12-19

    Mylan Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Mylan Pharmaceuticals is recalling Amlodipine and Valsartan tablets because FDA testing found the impurity N-nitrosodiethylamine (NDEA) in the active ingredient.

    Product
    AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereNHTSA·18V899000·2018-12-19

    General Motors Recalls 2019 Cadillac XTS for Front Seat Belt Defect

    General Motors is recalling 2019 Cadillac XTS vehicles because a missing rivet in the front seat belt buckle may allow it to separate during a crash, increasing injury risk.

    Product
    CADILLAC — CADILLAC XTS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0306-2019·2018-12-19

    Teva Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Teva Pharmaceuticals USA is recalling Amlodipine and Valsartan Tablets 10 mg/320 mg because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).

    Product
    Amlodipine and Valsartan Tablets 10 mg/320 mg (a) 30-count bottles (NDC 0093-7693-56) & 90-count bottles (NDC 0093-7693-98), 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 (Devices)·Z-0589-2019·2018-12-19

    Arjo Passive Clip Sling Recalled for Material Breakage Risk

    ArjoHuntleigh is recalling 10 units of Passive Clip Slings because the material may break during patient transfers, posing a risk of falls and serious injury.

    Product
    ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The Arjo Passive Clip Sling is a product intended for assisted transfer of patient/resident with limited ability to move. Designed to be used for one patient during hospital stay and assists the caregiver…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0314-2019·2018-12-19

    Mylan Recalls Valsartan Tablets Due to NDEA Impurity

    Mylan Pharmaceuticals is recalling Valsartan tablets because FDA labs confirmed the presence of the impurity N-nitrosodiethylamine (NDEA). The affected product was distributed throughout the United States.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0325-2019·2018-12-19

    Mylan Recalls Valsartan Tablets Due to Trace NDEA Impurity

    Mylan is recalling specific lots of Valsartan 80 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-0310-2019·2018-12-19

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

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

    Product
    Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg, (a) 30-count bottles (NDC 0093-7809-56) & 90-count bottles (NDC 0093-7809-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0606-2019·2018-12-19

    GE Healthcare Recalls Discovery NM/CT 670 DR Due to Electrical Hazard

    GE Healthcare is recalling four Discovery NM/CT 670 DR units because incorrect wiring of safety switches may prevent the system from shutting off power, creating an electrical hazard.

    Product
    Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and…
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Food)·F-0715-2019·2018-12-19

    Baraka Hot Curry Powder Recalled for High Lead Levels

    U.B.C. Food Distributors is voluntarily recalling Baraka Hot Curry Powder in 7 oz plastic jars due to high levels of lead.

    Product
    Baraka Hot Curry Powder packed in 7 OZ Plastic Jar
    Category
    Food
    Distribution
    9 states