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.

25901–25925 of 32215

  • SevereFDA (Food)·F-1611-2014·2014-03-12

    Tonia's Biscotti Sampler Bag Recalled for Undeclared Allergens

    Yukon Concessions Alaska LLC is recalling Tonia's Biscotti Sampler Bags due to undeclared wheat, soy, and milk.

    Product
    Sampler Bag Biscotti consists of 3 pieces of Almond dipped in Dark Chocolate; 3 pieces of Cranberry dipped in White Chocolate; and 3 pieces of Cranberry & Toasted Almonds. Sampler Bag is packaged in white windowed paper coated bakery bags and sold under Tonia's Biscotti…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1151-2014·2014-03-12

    Mira Health Recalls Unapproved Metha-Drol Extreme Dietary Supplement

    Mira Health Products Ltd. is recalling 5,555 bottles of Metha-Drol Extreme capsules because the product contains an unapproved steroid ingredient.

    Product
    METHA-DROL Extreme capsules, packaged as 60 capsules per bottle Pro-Anabolic Mass Stack Dietary Supplement, Manufactured for Blackstone Labs, Boca Raton, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1096-2014·2014-03-12

    Hospira Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns

    Hospira is recalling 603,768 bags of 0.9% Sodium Chloride Injection because solution leaked through the port cover, compromising sterility.

    Product
    0.9% Sodium Chloride Injection, USP 1000 mL Flexible Container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1140-2014·2014-03-12

    Vancomycin Eye Drops Recalled for Sterility Assurance Concerns

    Natures Pharmacy & Compounding Center is recalling all lots of Vancomycin (fortified) 25mg/ml ophthalmic solution due to quality control issues affecting sterility assurance.

    Product
    Vancomycin (fortified) 25mg/ml opth
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1124-2014·2014-03-12

    Methylcobalamin Recalled Due to Sterility Assurance Concerns

    Natures Pharmacy & Compounding Center is recalling all non-expired lots of Methylcobalamin due to quality control issues affecting sterility assurance.

    Product
    Methylcobalamin
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1618-2014·2014-03-12

    Tonia's Biscotti Chocolate Delight Recalled for Undeclared Allergens

    Yukon Concessions Alaska LLC is recalling Tonia's Biscotti Chocolate Delight due to undeclared wheat, soy, and milk.

    Product
    Chocolate Delight dipped in Dark Chocolate Biscotti-individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1143-2014·2014-03-12

    Phillips Respironics Recalls Trilogy Ventilators Due to Power Board Defect

    Phillips Respironics is recalling 572 Trilogy ventilators worldwide because a defective power management board component may cause loss of therapy.

    Product
    Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1060-2014·2014-03-12

    McKesson Anesthesia Care System Recalled for Data Mismatch

    McKesson Technologies is recalling 10 units of the Anesthesia Care system because patient case data did not match the patient data, including data from another case.

    Product
    McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care system is a computer based system which collects, processes,and records data both through manual entry and from monitors which themselves are attached to patients, such as in the operating room environment.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1610-2014·2014-03-12

    Dairy Rich Chocolate Ice Cream Recalled for Potential Peanut Allergen

    Ice Cream Specialities is voluntarily recalling Dairy Rich Chocolate Ice Cream because it may contain peanut butter, a peanut allergen.

    Product
    Chocolate Ice Cream manufactured under the Dairy Rich brand and packaged in a 1.75 quart (1.66 L) (56 oz.) carton.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1148-2014·2014-03-12

    Fresenius Kabi Recalls Heparin Sodium Injection Due to Subpotency

    Fresenius Kabi is recalling Heparin Sodium Injection vials because they may contain less active ingredient than labeled.

    Product
    HEPARIN SODIUM — HEPARIN SODIUM (HEPARIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide