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.

20051–20075 of 32117

  • SevereFDA (Drugs)·D-0990-2016·2016-06-15

    FDA Recalls Compounded HCG and Vitamin Injections for Sterility Concerns

    Well Care Compounding Pharmacy is recalling compounded HCG, methylcobalamin, and folic acid injections due to FDA inspection findings regarding sterility assurance.

    Product
    HCG/METHYLCOBALAMIN/FOLIC ACID,1000IU/5MG/0.4MG/ML; packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0961-2016·2016-06-15

    FDA Recalls Fataway Ultimate Stack Supplement for Unapproved Salicylic Acid

    Novacare, LLC is recalling Thin and Slim Fataway Ultimate Stack with Chromium because FDA sampling found unapproved salicylic acid in the dietary supplement.

    Product
    Thin and Slim Fataway Ultimate Stack with Chromium, packaged per 120 capsules. Distributed by Dale H Enterprises Inc. Lewisburg, PA 17837, www.fataway.org.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0969-2016·2016-06-15

    Novacare Recalls Thin and Slim Extreme Stack Fat Burner Supplement

    Novacare, LLC is recalling Thin and Slim Extreme Stack Fat Burner dietary supplements because FDA sampling confirmed the presence of salicylic acid.

    Product
    Thin and Slim Extreme Stack Fat Burner Dietary Supplement packaged in 90 capsule containers. TSN Labs Inc., P.O. Box 38, Midvale, UT 84047, 1-800-769-7290, www.tsn2000.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0978-2016·2016-06-15

    FDA Recalls 17-0H Progesterone Vials Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling 17-0H Progesterone vials because FDA inspections found GMP violations that may affect sterility.

    Product
    17-0H PROGESTERONE 250MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1009-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls SUPER TRI-MIX #1 Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling 869 vials of SUPER TRI-MIX #1 because FDA inspections found violations that may affect sterility.

    Product
    SUPER TRI-MIX #1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1020-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls TRI-MIX # 5 Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling TRI-MIX # 5 vials because FDA inspections found GMP violations that may affect sterility.

    Product
    TRI-MIX # 5, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1422-2016·2016-06-15

    Aldi Millville Protein Chew Bars Recalled for Listeria Risk

    Schulze & Burch Biscuit Co is recalling Aldi's Millville protein chew bars because a supplier reported a Listeria monocytogenes positive test for an ingredient.

    Product
    Aldi's Millville protein chew bars, dark chocolate peanut butter packaged 5 bars to a box in a yellow and brown box with brown and white lettering.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1013-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls Testosterone Cypionate Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling Testosterone Cypionate 150mg/mL vials because FDA inspections found GMP violations that may affect sterility.

    Product
    TESTOSTERONE CYPIONATE 150MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0973-2016·2016-06-15

    Novacare Recalls Unapproved Dietary Supplements Containing Salicylic Acid

    Novacare, LLC is recalling Xcellerator dietary supplements because FDA sampling confirmed the presence of salicylic acid in products marketed without an approved NDA/ANDA.

    Product
    Xcellerator (product not labeled)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1002-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls Methylcobalamin/Folic Acid Vials

    Well Care Compounding Pharmacy is recalling Methylcobalamin/Folic Acid vials due to GMP violations that may impact sterility.

    Product
    METHYLCOBALAMIN/FOLIC ACID; 10MG/0.8MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1016-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls TRI-MIX # 1 Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling TRI-MIX # 1 vials because FDA inspections found violations that may affect product sterility.

    Product
    TRI-MIX # 1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1007-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls QUAD-MIX #2 Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling QUAD-MIX #2 vials due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    QUAD-MIX #2, packaged in 5mL vial, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1019-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls TRI-MIX # 4 Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling 869 vials of TRI-MIX # 4 in Nevada due to GMP violations that may impact sterility.

    Product
    TRI-MIX # 4, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1370-2016·2016-06-15

    Pulmuone Noodles Recalled for Undeclared Milk Allergen

    Pulmuone Foods is recalling Noodles with Fire-roasted Black Bean Sauce because the product contains undeclared milk.

    Product
    Noodles with Fire-roasted Black Bean Sauce, 23.3oz, UPC 7 53214 30021 2, Food Item No. 30021, Pack Size: 16.
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-1427-2016·2016-06-15

    Publix Cranberry Nut & Seed Mix Recalled for Listeria Risk

    Publix Super Markets is recalling Cranberry Nut & Seed Mix due to possible Listeria monocytogenes contamination. The product was distributed in six southeastern states.

    Product
    Publix Cranberry Nut & Seed Mix, 7.05 ounce plastic container. Manufactured by Publix Supermarkets in Lakeland, FL.
    Category
    Food
    Distribution
    6 states
  • SevereNHTSA·16V433000·2016-06-14

    PJ Trailers Recalls T1 Trailers Due to Tongue Strength Defect

    PJ Trailers is recalling 2015-2016 T1 single axle tilt trailers because a notch in the steel tongue may compromise its strength, increasing crash risk.

    Product
    PJ TRAILERS — PJ TRAILERS T1
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·049-2016·2016-06-14

    G & M Co. Recalls Beef Products Due To Possible E. Coli O157:H7 Contamination

    G & M Co. is recalling approximately 3,586 pounds of beef products that may be contaminated with E. coli O157:H7. The products were shipped to retail locations in New Jersey and New York.

    Product
    G&M Co. — G & M Co. Recalls Beef Products Due To Possible E. Coli O157:H7 Contamination
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·16E057000·2016-06-13

    Triumph Recalls Aftermarket Brake Levers for 2016-2017 Motorcycles

    Triumph is recalling aftermarket adjustable brake levers for specific 2016-2017 motorcycles because they may contact the handlebar, preventing maximum braking force.

    Product
    TRIUMPH — TRIUMPH BONNEVILLE T100 BLACK A3, STREET TWIN, THRUXTON, BONNEVILLE T100 BLACK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·048-2016·2016-06-13

    Asian Jade Customs Brokerage Recalls Imported Sausage Products

    Asian Jade Customs Brokerage is recalling approximately 762 pounds of imported dried pork sausage that was not inspected at the U.S. point of entry.

    Product
    Asian Jade Customs Brokerage Recalls Sausage Products Distributed Without Benefit of Import Inspection
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·16V427000·2016-06-13

    Vermeer Recalls 2014-2016 TG5000 Trailers Due to Brake Defect

    Vermeer is recalling 2014-2016 TG5000 trailers because incorrect pushrod lengths may cause parking brakes to engage unintentionally, increasing crash risk.

    Product
    VERMEER — VERMEER TG5000
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V430000·2016-06-13

    Nissan Recalls Infiniti Q50 Models for Steering System Error

    Nissan is recalling 2014-2016 Infiniti Q50 and Q50 Hybrid vehicles because a steering system error may alter responsiveness and increase crash risk.

    Product
    INFINITI — INFINITI Q50, Q50 HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide