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.

20151–20175 of 32117

  • SevereNHTSA·16V397000·2016-06-02

    Tiffin Allegro Motorhomes Recalled for Steering Box Wear Risk

    Tiffin is recalling 2014-2016 Allegro motorhomes because incorrect steering box spacers can cause premature wear, leading to a sudden loss of steering ability and increased crash risk.

    Product
    TIFFIN — TIFFIN ALLEGRO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V394000·2016-06-02

    Autocar Recalls 2016-2017 Xpeditor Trucks for Engine Stall Risk

    Autocar is recalling 18 Xpeditor trucks due to a defective engine control module that may cause the engine to stall unexpectedly, increasing crash risk.

    Product
    AUTOCAR — AUTOCAR XPEDITOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0906-2016·2016-06-01

    FDA Recalls Super Hard Capsules Marketed Without Approval

    R Thomas Marketing, LLC is recalling Super Hard capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Super Hard, packaged in BIG BOX (20 small boxes / 6 capsules per box / 120 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0885-2016·2016-06-01

    Herb Viagra Recalled for Lack of FDA Approval

    R Thomas Marketing, LLC is recalling Herb Viagra because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Herb Viagra, packaged in Big Box (20 small boxes / 4 capsules per box / 80 capsules total), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0886-2016·2016-06-01

    Real Skill Recalled for Marketing Without FDA Approval

    R Thomas Marketing, LLC is recalling Real Skill capsules because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Real Skill, packaged in 20 small boxes / 4 capsules per box / 80 capsules total, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1759-2016·2016-06-01

    American Surgical Cotton Balls Recalled for Packaging Defect Compromising Sterility

    American Surgical Company is recalling 34 boxes of strung cotton balls due to packaging defects that compromise sterility. The products were distributed worldwide.

    Product
    American Surgical Cotton Balls-Strung 1/8" Ref Number: 30-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0889-2016·2016-06-01

    African Black Ant capsules recalled for lack of FDA approval

    R Thomas Marketing, LLC is recalling African Black Ant capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    African Black Ant, packaged in 8 small boxes / 6 capsules per box / 48 capsules total, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1636-2016·2016-06-01

    Hummingbird Med Recalls Hummi Micro Draw Blood Transfer Devices

    Hummingbird Med is recalling Hummi Micro Draw Blood Transfer Devices because the Y connector may separate from the cannula hub during use.

    Product
    ABG-HM-1 Hummi Micro Draw Blood Transfer Device Product Usage: It is used for blood transfer and collection from Peripheral Arterial Line Catheters.
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Drugs)·D-0892-2016·2016-06-01

    FDA Recalls Unapproved Zhong Hua Niu Bian Capsules Nationwide

    R Thomas Marketing, LLC is recalling Zhong Hua Niu Bian capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Zhong Hua Niu Bian, packaged in BIG BOX (6 small boxes / 6 capsules per box / 36 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0901-2016·2016-06-01

    Man King capsules recalled for lack of FDA approval

    R Thomas Marketing, LLC is recalling Man King capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Man King, packaged in BIG BOX (8 small boxes / 5 capsules per box / 40 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0867-2016·2016-06-01

    Fresenius Kabi Recalls Octreotide Acetate Injection Due to Impurities

    Fresenius Kabi USA is recalling Octreotide Acetate Injection vials because they failed impurities and degradation specifications.

    Product
    OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0899-2016·2016-06-01

    Plant Vigra Recalled for Lack of FDA Approval

    R Thomas Marketing, LLC is recalling Plant Vigra because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Plant Vigra, packaged in BIG BOX / (18 cans / 6 capsules per can / 108 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1321-2016·2016-06-01

    AA USA Trading Ginger Slices Recalled for Undeclared Sulfites

    AA USA Trading Inc. is recalling 8-ounce packages of Ginger Slices because they contain undeclared sulfites. The product was distributed in New York and New Jersey.

    Product
    AA USA Trading Inc. Ginger Slice Net Wt: 8 oz., AA USA Trading Inc. 47 Reid St. South River, NJ 08882
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0903-2016·2016-06-01

    Night Man capsules recalled for lack of FDA approval

    R Thomas Marketing, LLC is recalling Night Man capsules because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Night Man, packaged in SMALL BOX (6 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0896-2016·2016-06-01

    FDA Recalls Black Storm Capsules Marketed Without Approval

    R Thomas Marketing, LLC is recalling Black Storm capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Black Storm, packaged in SMALL BOX (6 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0891-2016·2016-06-01

    Bull's Genital Recalled for Marketing Without FDA Approval

    R Thomas Marketing, LLC is recalling Bull's Genital capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Bull's Genital, packaged in CASE (10 Cans / 10 capsules per can / 100 capsules),Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V382000·2016-06-01

    Audi Recalls A4 and A6 Vehicles Due to Air Bag Inflator Rupture Risk

    Volkswagen Group of America is recalling specific Audi A4 and A6 models because passenger air bag inflators may rupture during deployment, potentially causing serious injury or death.

    Product
    AUDI — AUDI A4, A6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16E051000·2016-06-01

    M.B. Sturgis Recalls Auto Changeover Propane Gas Regulators Due to Leak Risk

    M.B. Sturgis is recalling specific propane gas regulators where a cracked window may allow gas to leak, increasing fire risk. Dealers will replace the parts free of charge.

    Product
    EQUIPMENT:RECREATIONAL VEHICLE/TRAILER:LPG SYSTEMS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1380-2016·2016-06-01

    Sausage Maker Seasoning Recalled for Undeclared Milk Allergens

    The Sausage Maker, Inc. is recalling Smoked Pepperoni seasoning because the Fermento ingredient contains undeclared whey protein and skim milk powder.

    Product
    THE SAUSAGE MAKER SEASONING Smoked Pepperoni under the following labels: 1) Net Wt 2 lbs, 2) Net Wt 25 lbs, 3) Smoked Pepperoni Kit w/Home Pak, 4) Smoked Pepperoni Salami Kit
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1379-2016·2016-06-01

    Sausage Maker Seasoning Recalled for Undeclared Milk Allergens

    The Sausage Maker, Inc. is recalling Goetburg Summer Sausage seasoning due to undeclared whey protein and skim milk powder.

    Product
    THE SAUSAGE MAKER SEASONING Goetburg Summer Sausage under the following labels: 1) Net Wt: 2 lbs.8 oz, 2) Goteborg Summer Sausage Kit
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0876-2016·2016-06-01

    Akorn Recalls PerioRx Oral Rinse Due to Unknown Impurity

    Akorn, Inc. is recalling PerioRx oral rinse because multiple batches failed impurity specifications. The product contains an unknown impurity of chlorhexidine gluconate.

    Product
    PerioRx (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for Discus Dental, LLC, Ontario, CA 91761, UPC 4235 020 91701
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0868-2016·2016-06-01

    Teva Recalls Linezolid Injection Bags Due to Sterility Concerns

    Teva North America is recalling 546 bags of Linezolid Injection due to potential leaking that compromises sterility.

    Product
    Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-31), packaged in 10 x 300 mL Single Use Container bags per Box Pack (NDC 0703-9060-33), Rx only, Manufactured In Hungary By: Teva Pharmaceutical Works Ltd., Hungary, H-2100 Godollo, Tancsics M. ut 82…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0907-2016·2016-06-01

    FDA Recalls Zhen Gong Fu for Lack of Approved New Drug Application

    R Thomas Marketing, LLC is recalling Zhen Gong Fu capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Zhen Gong Fu, packaged in BIG BOX (16 small boxes / 2 capsules per box / 32 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0884-2016·2016-06-01

    FDA Recalls Black Ant Supplements Marketed Without Approval

    The FDA is recalling Black Ant supplements distributed by R Thomas Marketing, LLC because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Black Ant, packaged in Big Box (20 small boxes / 4 capsules per box / 80 capsules total), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide