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.

28226–28250 of 32252

  • SevereFDA (Devices)·Z-1372-2013·2013-06-05

    AsthmaNefrin Starter Kit Recalled for Choking Hazard

    Nephron Pharmaceuticals is recalling AsthmaNefrin Starter Kits because a component may dislodge and cause a choking hazard.

    Product
    AsthmaNefrin Starter Kit contains ten (10) AsthmaNefrin vials and one (1) EZ Breathe Atomizer. For the delivery of liquid medications for respiratory usage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-455-2013·2013-06-05

    Nora Apothecary Recalls Bimix Inj Penile Injection Due to Sterility Concerns

    Nora Apothecary is recalling Bimix Inj 30:1 MDV penile injections because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Bimix Inj 30:1 MDV: 5ml, 10 ml, 3x10ml, 2x10ml Penile Injection, 30 and 90 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-484-2013·2013-06-05

    Nora Apothecary Recalls Methylcobalamin Injections Due to Sterility Concerns

    Nora Apothecary and Alternative Therapies, Inc. is recalling Methylcobalamin Injections due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Methylcobalamin Inj 5mg/ml MDV: 5 ml, 10 ml, 12 ml, 20 ml Subcutaneous, 90 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-460-2013·2013-06-05

    Nora Apothecary Recalls PGE-1 Penile Injections Due to Sterility Concerns

    Nora Apothecary is recalling PGE-1 Penile Injections because FDA inspections raised concerns about quality control and assurance of sterility.

    Product
    PGE-1 Inj 40mcg/ml MDV, 5 ml Penile Injection, 90 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-469-2013·2013-06-05

    Nora Apothecary Vancomycin Ophthalmic Solution Recalled for Sterility Concerns

    Nora Apothecary is recalling Vancomycin Ophthalmic Solution due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Vancomycin Opth Soln14mg/ml PF, 10ml Opthalmic Soln, 30 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-479-2013·2013-06-05

    Nora Apothecary Recalls HCG Injections Due to Sterility Concerns

    Nora Apothecary and Alternative Therapies, Inc. is recalling HCG Inj 500un/ml MDV, 5 ml Subcutaneous due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    HCG Inj 500un/ml MDV, 5 ml Subcutaneous, 30 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-491-2013·2013-06-05

    Nora Apothecary Recalls Glutathione Injections Due to Sterility Concerns

    Nora Apothecary is recalling Glutathione 200mg/ml injections nationwide due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Glutathione 200mg/ml Inj SDV: 3x50ml 14 day expiration, 1x50ml 21 day expiration
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-482-2013·2013-06-05

    Nora Apothecary Recalls Hydroxycobalamin Injection Due to Sterility Concerns

    Nora Apothecary and Alternative Therapies, Inc. is recalling Hydroxycobalamin Injection 2500 mcg/ml due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Hydroxycobalamin Inj 2500 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-480-2013·2013-06-05

    Nora Apothecary Recalls Hydroxycobalamin Injections Due to Sterility Concerns

    Nora Apothecary is recalling Hydroxycobalamin Injections because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Hydroxycobalamin Inj 1000mcg/ml MDV: 10 ml, 15 ml, 20 ml, 30 ml Subcutaneous, 90 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-475-2013·2013-06-05

    Nora Apothecary Recalls Folic Acid Injection Due to Sterility Concerns

    Nora Apothecary is recalling Folic Acid Inj 5mg/ml due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Folic Acid Inj 5mg/ml MDV, 10 ml Subcutaneous, 90 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-453-2013·2013-06-05

    Nora Apothecary Recalls Bimix Inj 30:1 Syringes Due to Sterility Concerns

    Nora Apothecary is recalling Bimix Inj 30:1 syringes because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Bimix Inj 30 :1 Syr, 12x1.5 ml syr, 10x1.2 ml syr, 2x2 ml syr, 2x1 ml syr, 12x.05 ml syr Penile Injection,30 and 90 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1371-2013·2013-06-05

    FDA Recalls EZ Breathe Atomizers Due to Choking Hazard

    Nephron Pharmaceuticals is recalling EZ Breathe Atomizers because a component may dislodge, creating a choking hazard.

    Product
    EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-494-2013·2013-06-05

    Nora Apothecary Recalls Meperidine Injection Due to Sterility Concerns

    Nora Apothecary is recalling Meperidine 100mg/ml MDV, 5ml vials due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Meperidine 100mg/ml MDV, 5ml 90 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-459-2013·2013-06-05

    Nora Apothecary Recalls PGE-1 Penile Injections Due to Sterility Concerns

    Nora Apothecary and Alternative Therapies, Inc. is recalling PGE-1 Penile Injections because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    PGE-1 Inj 30mcg/ml MDV, 7 ml Penile Injection, 90 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-483-2013·2013-06-05

    Nora Apothecary Recalls Methylcobalamin Injections Due to Sterility Concerns

    Nora Apothecary and Alternative Therapies, Inc. is recalling Methylcobalamin Injections due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Methylcobalamin Inj 1mg/ml MDV, 10 ml, 15 ml, 20 ml, 30 ml, 4x30 ml Subcutaneous, 90 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-487-2013·2013-06-05

    Nora Apothecary Recalls Methylcobalamin Injections Due to Sterility Concerns

    Nora Apothecary and Alternative Therapies, Inc. is recalling Methylcobalamin Injections due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Methylcobalamin Inj 25mg/ml Syr: 8x0.06mlsyr, 10x0.06 ml syr, 12x0.06 ml syr Subcutaneous, 30 and 90 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-458-2013·2013-06-05

    Nora Apothecary Recalls PGE-1 Penile Injections Due to Sterility Concerns

    Nora Apothecary and Alternative Therapies, Inc. is recalling PGE-1 penile injections nationwide due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    PGE-1 Inj 20mcg/ml MDV: 5ml, 7ml, 10ml, 20ml Penile Injection, 90 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-478-2013·2013-06-05

    Nora Apothecary Recalls HCG Injections Due to Sterility Concerns

    Nora Apothecary is recalling HCG Inj 1250 un/ml MDV injections because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    HCG Inj 1250 un/ml MDV, 4 ml Subcutaneous, 30 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-488-2013·2013-06-05

    Nora Apothecary Recalls Hydroxyprogesterone Injections Due to Sterility Concerns

    Nora Apothecary and Alternative Therapies, Inc. is recalling Hydroxyprogesterone Inj 250mg/ml MDV, 5 ml Intramuscular due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Hydroxyprogesterone Inj 250mg/ml MDV, 5 ml Intramuscular, 30 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1459-2013·2013-06-05

    Nature's Candy Recalls Maple Macadamia Nuts Due to Salmonella Risk

    Nature's Candy, Inc. is recalling 25 lb bulk boxes of Maple Macadamia Nuts in California and Colorado due to potential Salmonella contamination.

    Product
    Maple Macadamia Nuts, 25 lb bulk boxes
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1458-2013·2013-06-05

    Tropical Valley Foods Recalls Dark Chocolate Bananas for Undeclared Allergens

    Tropical Valley Foods is recalling next by Nature brand Dark Chocolate Bananas because the product contains undeclared walnuts and milk.

    Product
    next by Nature brand DARK CHOCOLATE BANANAS, NET WT. 3 Oz. (85g), UPC 8 17582 25600 4, Produced by Tropical Valley Foods
    Category
    Food
    Distribution
    4 states