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.

13226–13250 of 29186

  • SevereNHTSA·18V826000·2018-11-21

    Navistar Recalls 2018-2019 International Trucks for Clutch Assembly Defect

    Navistar is recalling certain 2018-2019 International trucks because a clutch component may fail, causing unintended vehicle movement and increasing crash risk.

    Product
    INTERNATIONAL — INTERNATIONAL RH, MV, LONESTAR, HV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0259-2019·2018-11-21

    Sandoz Recalls Isosorbide Dinitrate Tablets Due to Cross Contamination

    Sandoz Inc. is recalling Isosorbide Dinitrate Tablets 5 mg due to cross-contamination with other products. The recall affects 7,817 bottles distributed nationwide.

    Product
    Isosorbide Dinitrate Tablets, USP 5 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-223-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0260-2019·2018-11-21

    Sandoz Recalls Isosorbide Dinitrate Tablets Due to Cross Contamination

    Sandoz Inc. is recalling 5,100 bottles of Isosorbide Dinitrate Tablets, USP 10 mg, due to cross contamination with other products.

    Product
    Isosorbide Dinitrate Tablets, USP 10 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-225-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0542-2019·2018-11-21

    Working Cow Thin Mint Ice Cream Recalled for Listeria Risk

    Working Cow Homemade Inc. is recalling 336 tubs of Thin Mint Ice Cream due to potential Listeria monocytogenes contamination.

    Product
    Thin Mint Ice Cream, 3 gallons
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0276-2019·2018-11-21

    Taro Recalls Children's Allergy Solution Due to Impurity

    Taro Pharmaceuticals is recalling 12,432 bottles of Children's 24 Hour Allergy Oral Solution because an unknown impurity exceeded limits during stability testing.

    Product
    Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, Bubble Gum Flavor, Sugar Free/Dye Free, 4 FL OZ (120 mL) bottle, Dist. by Meijer Distribution, Inc., Grand Rapids, MI 40644, NDC 41250-106-08, UPC 7 13733 88578 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0426-2019·2018-11-21

    AROA Biosurgery Recalls OviTex 1S Reinforced BioScaffold Mesh Devices

    AROA Biosurgery is recalling OviTex 1S Reinforced BioScaffold mesh devices because the suture material degraded, causing them to fail burst specifications.

    Product
    OviTex 1S Reinforced BioScaffold 18x22cm, Part Number F10256-1822G
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Food)·F-0464-2019·2018-11-21

    Working Cow Rum Raisin Ice Cream Recalled for Listeria Risk

    Working Cow Homemade Inc. is recalling 2,012 tubs of Rum Raisin Ice Cream due to potential Listeria monocytogenes contamination.

    Product
    Rum Raisin Ice Cream, 3 gallons
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0553-2019·2018-11-21

    Working Cow Homemade Ice Cream Recalled for Listeria Contamination

    Working Cow Homemade Inc. is recalling 190 tubs of Choc Chocolate Chip F.Y. Ice Cream due to potential Listeria monocytogenes contamination.

    Product
    Choc Chocolate Chip F.Y. Ice Cream, 3 gallons
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0697-2019·2018-11-21

    Sirob Imports Recalls FC Finest Choice Hot Curry Powder for Lead

    Sirob Imports, Inc. is recalling 12,100 pounds of FC Finest Choice Hot Curry Powder because the product may contain elevated levels of lead.

    Product
    FC Finest Choice Hot Curry Powder, Packed By SIROB IMPORTS, INC. packaged in a 50 pound box.
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0696-2019·2018-11-21

    Sirob Imports Recalls Curry Powder Due to Elevated Lead Levels

    Sirob Imports, Inc. is recalling various brands of curry powder because the products may contain elevated levels of lead.

    Product
    Curry powder packaged under bulk, retail, and food service labels. Bulk: CURRY POWDER Net Weight 55 LBS, DISTRIBUTED BY SIROB IMPORTS LINDENHURST, NEW YORK USA (sold in a 55 pound bag) Packaged under the following retail brands: Corrado 16 oz. UPC: 0 12729 01100…
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0250-2019·2018-11-21

    Kadesh Recalls Puriton Eye Relief Drops for Non-Sterility

    Kadesh International is recalling Puriton Eye Relief Drops because they were manufactured under non-sterile production conditions.

    Product
    puriton EYE RELIEF DROPS, 0.5 oz (15 ml) bottle, Kadesh Inc., NDC#7079600115, UPC 7 36972 16799 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0538-2019·2018-11-21

    Working Cow Coconut Chocolate Ice Cream Recalled for Listeria Risk

    Working Cow Homemade Inc. is recalling 365 tubs of Toaste Coconut with Chocolate Ice Cream due to potential Listeria monocytogenes contamination.

    Product
    Toaste Coconut with Chocolate Ice Cream, 3 gallons
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0486-2019·2018-11-21

    Working Cow Almond Joy Ice Cream Recalled for Listeria Risk

    Working Cow Homemade Inc. is recalling 997 tubs of Almond Joy Ice Cream due to potential Listeria monocytogenes contamination.

    Product
    Almond Joy Ice Cream, 3 gallons
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0561-2019·2018-11-21

    Working Cow Homemade Inc. Recalls JY Mint Chip Ice Cream

    Working Cow Homemade Inc. is recalling 115 tubs of JY Mint Chip Ice Cream due to potential Listeria monocytogenes contamination.

    Product
    JY Mint Chip Ice Cream, 3 gallons
    Category
    Food
    Distribution
    0 states