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.

25926–25950 of 32215

  • SevereFDA (Drugs)·D-1101-2014·2014-03-12

    Bladder Instillation Recalled for Lack of Sterility Assurance

    Natures Pharmacy & Compounding Center is recalling all lots of Bladder Instillation due to quality control concerns affecting sterility assurance.

    Product
    Bladder Instillation
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1102-2014·2014-03-12

    Bleomycin Sulfate Recalled Due to Sterility Assurance Concerns

    Natures Pharmacy & Compounding Center is recalling all non-expired lots of Bleomycin Sulfate 1unit/ml due to quality control issues affecting sterility assurance.

    Product
    Bleomycin Sulfate 1unit/ml
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1150-2014·2014-03-12

    Shimadzu Recalls Mobile X-ray Systems Due to Metal Plate Cracking Risk

    Shimadzu Medical Systems is recalling 56 mobile X-ray systems because a connecting metal plate may crack, posing a structural safety risk.

    Product
    Mobile X-ray System, Model: MUX-100, MUX-100H Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannnot move and/or of outpatients in emergency
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1621-2014·2014-03-12

    Mandarin Orange Tozzetti Biscotti Recalled for Undeclared Allergens

    Yukon Concessions Alaska LLC is recalling Mandarin Orange Tozzetti Biscotti due to undeclared wheat, soy, and milk.

    Product
    Mandarin Orange Tozzetti Biscotti - individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1598-2014·2014-03-12

    Rise n Roll Bakery Recalls Cinnamon Caramel Donuts for Undeclared Egg

    Rise'n Roll Bakery is recalling Cinnamon Caramel Donuts and Donut Holes because they contain an undeclared egg ingredient. The products were sold in multiple states and online.

    Product
    Rise n Roll Bakery & Deli, Cinnamon Caramel Donuts, sold individually and found in 6 count (436 g) UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties and in Cinnamon Caramel Donut Holes, 1.05 lb, UPC Code…
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Drugs)·D-1105-2014·2014-03-12

    Natures Pharmacy Recalls Cyano B-12 Due to Sterility Concerns

    Natures Pharmacy & Compounding Center is recalling Cyano B-12 (Cmpd) 1000mcg/ml due to quality control issues affecting sterility assurance.

    Product
    Cyano B-12 (Cmpd) 1000mcg/ml
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1599-2014·2014-03-12

    Rise n Roll Bakery Recalls Glazed Donuts for Undeclared Egg

    Rise'n Roll Bakery is recalling glazed donuts because they contain egg, which is not listed on the label.

    Product
    Rise n Roll Bakery & Deli, Glazed Donuts, sold individually and found in 6 count (436 g) UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties Glazed Donuts Enriched wheat flour, soybean oil, dextrose…
    Category
    Food
    Distribution
    11 states
  • SevereNHTSA·14V120000·2014-03-12

    Keystone Recalls 2014 Fifth Wheels and Travel Trailers for Axle Bearing Defect

    Keystone is recalling specific 2014 fifth wheels and travel trailers because insufficient lubrication in the inner wheel bearings may cause the wheel to seize or separate, increasing crash risk.

    Product
    KEYSTONE — KEYSTONE BULLET, SPRINGDALE, PASSPORT, HIDEOUT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1612-2014·2014-03-12

    Yukon Concessions Recalls Lemon Biscotti for Undeclared Allergens

    Yukon Concessions Alaska LLC is recalling Lemon Biscotti dipped in White Chocolate due to undeclared wheat, soy, and milk.

    Product
    Lemon Biscotti dipped in White Chocolate Bag, 13 oz., sold in white windowed paper coated bakery bags, And individually wrapped in cellophane - net wt. 2 oz.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1616-2014·2014-03-12

    Tonia's Biscotti Recalled for Undeclared Wheat, Soy, and Milk Allergens

    Yukon Concessions Alaska LLC is recalling Tonia's Biscotti Traditional Toasted Almond Biscotti due to undeclared wheat, soy, and milk.

    Product
    Traditional Toasted Almond Biscotti-individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1136-2014·2014-03-12

    Terbutaline/Ipratropium Recall Due to Sterility Assurance Concerns

    Natures Pharmacy & Compounding Center is recalling all lots of Terbutaline/Ipratropium 0.5mg/2.5ml due to quality control issues affecting sterility assurance.

    Product
    Terbutaline/Ipratropium 0.5mg/2.5ml
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1109-2014·2014-03-12

    FDA Recalls Estradiol and Testosterone Compounds for Sterility Concerns

    Natures Pharmacy & Compounding Center is recalling all lots of Estradiol Cypionate and Testosterone Cypionate due to sterility assurance concerns identified during an FDA inspection.

    Product
    Estradiol Cypionate 2mg/cc testosterone cypionoate 50mg
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1126-2014·2014-03-12

    Papaverine Injection Recalled for Lack of Sterility Assurance

    Natures Pharmacy & Compounding Center is recalling Papaverine 1nj 30mg/ml due to quality control concerns that present a potential risk to sterility assurance.

    Product
    Papaverine 1nj 30mg/ml
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1596-2014·2014-03-12

    Rise n Roll Bakery Apple Fritters Recalled for Undeclared Egg

    Rise'n Roll Bakery is recalling Apple Fritters because they contain an undeclared egg ingredient, posing a risk to individuals with egg allergies.

    Product
    Rise n Roll Bakery & Deli, Apple Fritter, sold individually and found in 6 count (436 g) UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties Apple Fritter Enriched wheat flour, apples, soybean oil…
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-1595-2014·2014-03-12

    Rise n Roll Bavarian Creme Donuts Recalled for Undeclared Egg

    Rise'n Roll Bakery is recalling Bavarian Creme Donuts because they contain an undeclared egg ingredient, posing a risk to individuals with egg allergies.

    Product
    Rise n Roll Bakery & Deli, Bavarian Creme Donuts, sold individually and found in 6 count (436 g) UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties Bavarian Creme Donuts Enriched wheat flour…
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Drugs)·D-1115-2014·2014-03-12

    Gentamycin Injection Recalled Due to Sterility Assurance Concerns

    Natures Pharmacy & Compounding Center is recalling all lots of Gentamycin 80mg/1000cc 0.9% NS due to quality control issues affecting sterility assurance.

    Product
    Gentamycin 80mg/1000cc 0.9% NS
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1123-2014·2014-03-12

    Methotrexate Intraocular Recall Due to Sterility Assurance Concerns

    Natures Pharmacy & Compounding Center is recalling all unexpired lots of Methotrexate Intraocular 400mcg 0.1cc due to quality control issues affecting sterility assurance.

    Product
    Methotrexate Intraocular 400mcg 0.1cc
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1604-2014·2014-03-12

    Big Red Tomato Packers Recalls Whole Tomatoes Due to Salmonella

    Big Red Tomato Packers, LLC is recalling 790 boxes of whole tomatoes due to a positive Salmonella finding. The product was distributed to Florida, Michigan, Minnesota, North Carolina, Pennsylvania, and Tennessee.

    Product
    Whole (round) Tomatoes packed in cardboard boxes of 20 and 25 lbs each.
    Category
    Food
    Distribution
    6 states