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.

15476–15500 of 29205

  • SevereNHTSA·17V581000·2017-09-20

    Rosenbauer Commander Recall: Diesel Fuel Pump Gear May Slip

    Rosenbauer is recalling one 2017 Commander emergency vehicle because a fuel pump gear may slip, causing sudden engine stall and crash risk.

    Product
    ROSENBAUER — ROSENBAUER COMMANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1159-2017·2017-09-20

    Bella Pharmaceuticals Recalls Fluorescein Sodium Vials Due to Sterility Concerns

    Bella Pharmaceuticals is recalling 644 vials of Fluorescein Sodium due to a lack of assurance of sterility. The affected lot was distributed nationwide.

    Product
    Fluorescein Sodium, 5mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1155-2017·2017-09-20

    Bella Pharmaceuticals Recalls MIC 25/50/50 Vials Due to Sterility Concerns

    Bella Pharmaceuticals is recalling MIC 25/50/50 vials because the company cannot ensure the product is sterile. The recall affects 5 vials distributed nationwide.

    Product
    MIC 25/50/50, 30mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1146-2017·2017-09-20

    Bella Pharmaceuticals Recalls PF-Glutathione Vials Due to Sterility Concerns

    Bella Pharmaceuticals is recalling 82 vials of PF-Glutathione 200mg/ml because the product lacks assurance of sterility.

    Product
    PF-Glutathione 200mg/ml, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659 1 (877) BELLA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3530-2017·2017-09-20

    Leader Liquid Multivitamin Supplement Recalled for B. cepacia Contamination

    Leader Liquid Multivitamin Supplement for Infants and Toddlers is being voluntarily recalled due to possible contamination with B. cepacia, which can cause serious infections in vulnerable patients.

    Product
    Leader Liquid Multivitamin Supplement for Infants and Toddlers , 1 2/3 oz (50 mL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3529-2017·2017-09-20

    Major Tri-Vita Drops Recalled for Possible B. cepacia Contamination

    The Harvard Drug Group is voluntarily recalling Major Tri-Vita Drops due to possible contamination with B. cepacia, which may cause serious infections in vulnerable patients.

    Product
    Major Tri-Vita Drops, 1 2/3 oz (50 mL)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1158-2017·2017-09-20

    Bella Pharmaceuticals Recalls Sodium Bicarbonate Vials Due to Sterility Concerns

    Bella Pharmaceuticals is recalling specific lots of Sodium Bicarbonate 8.4% vials because the company cannot ensure the product is sterile.

    Product
    Sodium Bicarbonate 8.4%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1143-2017·2017-09-20

    Andropharm M1 Alpha capsules recalled for lack of FDA approval

    Andropharm, LLC is recalling 1,250 bottles of M1 Alpha capsules sold in Florida because the product was marketed without an approved NDA or ANDA.

    Product
    ANDROPHARM M1 ALPHA (Methyl-1-Etiocholenolol-Epietiocholanollone 20 mg) capsule, packaged in 60-count bottle, Amazon.com, UPC 6 42125 50292 4
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-3521-2017·2017-09-20

    Rugby Polyvitamin Liquid Recalled for Possible B. cepacia Contamination

    The Harvard Drug Group is voluntarily recalling Rugby Polyvitamin Liquid due to possible contamination with B. cepacia, which may cause serious infections in vulnerable patients.

    Product
    Rugby Polyvitamin Liquid, 1 2/3 oz (50 mL)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3518-2017·2017-09-20

    Rugby Fer-iron Liquid Recalled for B. cepacia Contamination

    The Harvard Drug Group is voluntarily recalling Rugby Fer-iron Liquid due to possible contamination with B. cepacia, which may cause serious infections in vulnerable patients.

    Product
    Rugby Fer-iron Liquid, 1 and 2/3 oz., 50 mL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3527-2017·2017-09-20

    Major Poly-Vita Drops Recalled for B. cepacia Contamination

    The Harvard Drug Group is voluntarily recalling Major Poly-Vita Drops due to possible B. cepacia contamination, which poses a serious infection risk to immunocompromised patients.

    Product
    Major Poly-Vita Drops, 1 2/3 oz (50 mL)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1161-2017·2017-09-20

    Bella Pharmaceuticals Recalls BevaDex Syringes Due to Sterility Concerns

    Bella Pharmaceuticals is recalling 200 prefilled BevaDex syringes nationwide because the company cannot guarantee the product's sterility.

    Product
    BevaDex (bevacizumab) 0.06mL Prefilled 32 g (1.25mg/1mg) Syringes, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659 (877) BELLA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V580000·2017-09-20

    Navistar Recalls 2016 IC Bus CE School Buses for Steering Defect

    Navistar is recalling 2016 IC Bus CE school buses because a steering component may loosen, potentially causing a loss of steering and increasing crash risk.

    Product
    IC BUS — IC BUS CESB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1151-2017·2017-09-20

    Bella Pharmaceuticals Recalls B-Complex Vials Due to Sterility Concerns

    Bella Pharmaceuticals is recalling 45 vials of B-Complex due to a lack of assurance of sterility. The affected lot is BPBC3080517, expiring 2/5/18.

    Product
    B-Complex, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659,1 (877) BELLA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1141-2017·2017-09-20

    Centurion Labs Recalls Ninjacof-A Oral Solution Due to Microbial Contamination

    Centurion Labs is recalling Ninjacof-A oral solution due to potential B. cepacia contamination. Consumers should stop using the product and return it to the pharmacy.

    Product
    Ninjacof-A (Acetaminophen 160 mg, Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) Oral Solution, 16 fl. oz. (473 mL), Cotton Candy Flavor, Manufactured for: Centurion Labs, LLC Birmingham, AL 35243 --- NDC 23359-033-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3523-2017·2017-09-20

    Rugby Tri-vitamin Liquid Recalled for B. cepacia Contamination

    The Harvard Drug Group is voluntarily recalling Rugby Tri-vitamin Liquid due to possible contamination with B. cepacia, which poses a risk of serious infection for vulnerable patients.

    Product
    Rugby Tri-vitamin Liquid, 1 2/3 oz (50 mL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3526-2017·2017-09-20

    Voluntary Recall of Major Ferrous Drops Due to B. cepacia Contamination

    The Harvard Drug Group is voluntarily recalling Major Ferrous Drops due to possible B. cepacia contamination, which poses a serious infection risk to vulnerable patients.

    Product
    Major Ferrous Drops, 1 2/3 oz (50 mL)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3109-2017·2017-09-20

    Leonhard Lang Skintact Defibrillation Electrodes Recalled for Connection Failure

    Leonhard Lang is recalling Skintact defibrillation electrodes that may fail to connect with ZOLL AED PLUS devices, potentially delaying life-saving treatment.

    Product
    Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only. Used with automated external…
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1160-2017·2017-09-20

    Bella Pharmaceuticals Recalls Bevacizumab Syringes Due to Sterility Concerns

    Bella Pharmaceuticals is recalling 2,334 Bevacizumab prefilled syringes nationwide due to a lack of assurance of sterility.

    Product
    Bevacizumab Prefilled 30g and 31 gram 1.25mg/0.05mL Syringes, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3528-2017·2017-09-20

    Voluntary Recall of Major Poly-Vita Drops Due to B. cepacia Contamination

    The Harvard Drug Group is voluntarily recalling Major Poly-Vita Drops with Iron due to possible contamination with B. cepacia, which may cause serious infections in vulnerable patients.

    Product
    Major Poly-Vita Drops with Iron, 1 2/3 oz (50 mL)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1148-2017·2017-09-20

    Bella Pharmaceuticals Recalls Mannitol 20% Vials Due to Sterility Concerns

    Bella Pharmaceuticals is recalling Mannitol 20% 10 mL vials because the company cannot ensure the product is sterile.

    Product
    Mannitol 20%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3515-2017·2017-09-20

    Rugby Calcionate Syrup Recalled for Possible B. cepacia Contamination

    The Harvard Drug Group is voluntarily recalling Rugby Calcionate Syrup due to possible contamination with B. cepacia, which may cause serious infections in vulnerable patients.

    Product
    Rugby Calcionate Syrup, One Pint (473 mL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1142-2017·2017-09-20

    Andropharm Sten Z capsules recalled for lack of FDA approval

    Andropharm, LLC is recalling 150 bottles of Andropharm Sten Z capsules because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    ANDROPHARM STEN Z (2, 17a-Dimethyl-17b-hydroxy-5a-androst-1-en-3-one 10mg and 17b-hydroxy-2a, 17b-dimethyl-5a-androstan-3-one azine 10 mg) capsule, packaged in 60-count bottle, Andropharm.com, UPC: 6 42125 50294 8
    Category
    Drug
    Distribution
    1 state