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.

15951–15975 of 29205

  • SevereFDA (Drugs)·D-0878-2017·2017-06-07

    SCA Pharmaceuticals Recalls Leaking Magnesium Sulfate Injectable Bags

    SCA Pharmaceuticals is recalling 40 bags of Magnesium Sulfate injectable solution due to seam leaks that compromise sterility.

    Product
    MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0737-32
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0875-2017·2017-06-07

    SCA Pharmaceuticals Recalls Hydrocodone Injectable Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 87 bags of Hydromorphone HCL injectable solution because the bags are leaking at the seam, compromising sterility.

    Product
    HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volume 100mL, Single Dose Container bag, (Total HYDROmorphone Dose 20 mg per 100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0300-55
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0876-2017·2017-06-07

    SCA Pharmaceuticals Recalls Leaking Cefazolin Sodium Injectable Bags

    SCA Pharmaceuticals is recalling 240 bags of cefazolin sodium injectable due to seam leaks that compromise sterility.

    Product
    ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 2g, Total Approximate Volume 100 mL, Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0522-32
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0872-2017·2017-06-07

    SCA Pharmaceuticals Recalls Fentanyl Injection Bags Due to Seam Leaks

    SCA Pharmaceuticals is recalling 118 bags of fentanyl injection due to seam leaks that compromise sterility. The product was distributed nationwide in the USA.

    Product
    fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0229-32
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2291-2017·2017-06-07

    MusclMasster Recalls Al-Er-G Capsules Containing Banned Ephedra Ingredient

    MusclMasster, LLC is recalling Al-Er-G Capsules because they contain ephedra herb, an ingredient banned by the FDA.

    Product
    The Green Herb 100% Natural AL-ER-G, 60 and 150 Capsules, Dietary supplement, This item is packed in a white bottle with a white cap. Each bottle contains 60 or 150 capsules, each capsule is 180 mg of ephedra herb in a 650 mg capsule. Batch#1892; product# 314.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0873-2017·2017-06-07

    SCA Pharmaceuticals Recalls Fentanyl Injection Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 370 bags of fentanyl injection solution because the bags were leaking at the seam, compromising sterility.

    Product
    fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0202-32
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V365000·2017-06-05

    Hyundai Recalls 2017 Santa Fe Sport for Seat Belt Anchor Defect

    Hyundai is recalling 2017 Santa Fe Sport vehicles because the driver's seat belt anchor bolt may not be sufficiently tightened, increasing injury risk in a collision.

    Product
    HYUNDAI — HYUNDAI SANTA FE SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V362000·2017-06-02

    Thor Motor Coach Recalls 2017 Challenger 37YT Motorhomes for Exhaust Defect

    Thor Motor Coach is recalling 2017 Challenger 37YT motorhomes because the generator exhaust pipe may be mislocated or missing, creating a carbon monoxide risk.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH CHALLENGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·058-2017·2017-06-02

    P&S Bakery Recalls Pepperoni Rolls Due to Foreign Matter Contamination

    P&S Bakery is recalling approximately 2,959 pounds of Gia Russa brand pepperoni rolls due to possible contamination with clear meat casing. No illnesses have been reported.

    Product
    P&S Bakery, Inc — P&S Bakery, Inc. Recalls Pepperoni Product Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    4 states
  • SevereNHTSA·17V360000·2017-06-02

    MCI Recalls 2014-2017 J4500 Motor Coaches Due to Brake Hose Defect

    Motor Coach Industries is recalling 2014-2017 J4500 motor coaches because over-tightened front brake hose clamps may damage the hoses, potentially increasing stopping distance and crash risk.

    Product
    MCI — MCI J4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V355000·2017-06-01

    Mazda Recalls 2004 RX-8 Vehicles for Front Suspension Control Arm Defect

    Mazda is recalling 2004 RX-8 vehicles because a crack in the front suspension lower control arm ball joint socket may cause the ball joint to separate, potentially leading to loss of steering control.

    Product
    MAZDA — MAZDA RX-8
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V357000·2017-06-01

    Polaris Recalls 2015-2017 Slingshot Vehicles for Missing Swingarm Grommets

    Polaris is recalling 2015-2017 Slingshot vehicles because missing grommets on replacement swingarms may allow debris to contaminate the rear wheel speed sensor, disabling ABS and traction control.

    Product
    POLARIS — POLARIS SLINGSHOT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0855-2017·2017-05-31

    Sato Clear Eye Drops Recalled for Sterility Assurance Failure

    Sato Pharmaceutical is recalling Sato Clear eye drops because the firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

    Product
    SATO CLEAR (naphazoline hydrochloride) Redness Reliever Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-044-01
    Category
    Drug
    Distribution
    2 states
  • SevereNHTSA·17V351000·2017-05-31

    Spartan Recalls 2010-2014 Chassis Due to Starter Motor Fire Risk

    Spartan Motors is recalling 2010-2014 K2, K3, and Gladiator chassis because a starter motor component may break, causing overheating and increasing fire risk.

    Product
    SPARTAN — SPARTAN K3, GLADIATOR, K2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V349000·2017-05-31

    Pierce Fire Trucks Recalled for Rear Sway Bar Detachment Risk

    Pierce Manufacturing is recalling 2012-2017 fire trucks because a rear sway bar may detach, increasing crash risk during steering.

    Product
    PIERCE — PIERCE ENFORCER, ARROW XT, QUANTUM, VELOCITY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0854-2017·2017-05-31

    Sato Pharmaceutical Recalls Optic Splash Eye Drops Due to Sterility Concerns

    Sato Pharmaceutical Inc. is recalling 10,130 bottles of Optic Splash eye drops because the firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

    Product
    Optic Splash (naphazoline hydrochloride) Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-501-01.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0856-2017·2017-05-31

    Sato Pharmaceutical Recalls DORAMA-NEO Eye Wash Due to Sterility Concerns

    Sato Pharmaceutical Inc. is recalling 14,325 bottles of DORAMA-NEO eye wash because the manufacturer failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

    Product
    DORAMA-NEO (naphazoline hydrochloride) Eye wash, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-020-01
    Category
    Drug
    Distribution
    2 states
  • SevereNHTSA·17V348000·2017-05-30

    Pierce Fire Trucks Recalled for Rear Axle Shaft Defect

    Pierce Manufacturing is recalling 1999-2013 fire trucks with electric All-steer rear steering due to improperly heat-treated axle shafts that may break.

    Product
    PIERCE — PIERCE VELOCITY, QUANTUM, ENFORCER, ARROW XT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·056-2017·2017-05-26

    Cauldron Soups Recalls Beef Broth Products Produced Without Federal Inspection

    Cauldron Soups, LLC is recalling approximately 5,163 pounds of beef broth products produced without federal inspection. No illnesses have been reported.

    Product
    Somi Foods, Inc — Cauldron Soups, LLC Recalls Beef Broth Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·17V345000·2017-05-26

    VanLeigh Recalls 2015-2018 Vilano Trailers Due to Spare Tire Winch Defect

    VanLeigh is recalling 2015-2018 Vilano fifth-wheel recreational trailers because the spare tire winch may not be properly fastened, posing a crash risk if the tire falls off.

    Product
    VANLEIGH — VANLEIGH VILANO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·055-2017·2017-05-25

    Golden Gourmet Recalls Frozen Waffle and Turkey Sausage Products Due to Listeria

    Golden Gourmet is recalling approximately 5,248 pounds of frozen waffle and turkey sausage products due to possible Listeria monocytogenes contamination. The products were shipped to institutions in six states.

    Product
    Golden Gourmet, LLC — Golden Gourmet Recalls Frozen Waffle and Turkey Sausage Products Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    6 states