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.

15326–15350 of 29202

  • SevereFDA (Drugs)·D-0026-2018·2017-11-01

    Banner Pharmacy Recalls Vancomycin Bags Due to Sterility Concerns

    Banner Pharmacy Services is recalling 3,136 bags of Vancomycin 1.5 grams in 0.9% Sodium Chloride due to a lack of assurance of sterility.

    Product
    VANCOmycin 1.5 grams added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025002501
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0045-2018·2017-11-01

    Pharmedium Recalls Subpotent Oxytocin Infusion Bags Nationwide

    Pharmedium Services, LLC is voluntarily recalling 763 bags of compounded Oxytocin 30 units in Lactated Ringer's USP. The recall was initiated because the drug was found to be subpotent.

    Product
    Oxytocin 30 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-243-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0028-2018·2017-11-01

    Banner Pharmacy Recalls Norepinephrine Bags Due to Sterility Concerns

    Banner Pharmacy Services is recalling 481 bags of Norepinephrine Bitartrate in 0.9% Sodium Chloride due to a lack of assurance of sterility.

    Product
    Norepinephrine Bitartrate16 mg added to 0.9% Sodium Chloride 250 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025014801
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0023-2018·2017-11-01

    Banner Pharmacy Recalls Oxytocin Infusion Bags Due to Sterility Concerns

    Banner Pharmacy Services is recalling Oxytocin 30 units in 0.9% Sodium Chloride bags because the FDA determined there is a lack of assurance of sterility.

    Product
    OXYtocin 30 units added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025000101
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0018-2018·2017-11-01

    Banner Pharmacy Recalls Fentanyl Citrate Syringes Due to Sterility Concerns

    Banner Pharmacy Services is recalling fentanyl citrate syringes because the agency could not ensure the product was sterile.

    Product
    fentanyl citrate (PF) 1100 mcg (20 mcg/mL) 55 mL syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025011001
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0038-2018·2017-11-01

    Pharmedium Recalls Subpotent Oxytocin Injection Bags Nationwide

    Pharmedium Services, LLC is voluntarily recalling Oxytocin 20 units in Lactated Ringer's Injection USP bags because the drug was found to be subpotent.

    Product
    Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag, Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-241-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0037-2018·2017-11-01

    Pharmedium Recalls Subpotent Oxytocin Injection Bags Nationwide

    Pharmedium Services, LLC is voluntarily recalling 2,232 bags of compounded Oxytocin injection because the drug was found to be subpotent.

    Product
    Oxytocin 15 units added to 250 mL Lactated Ringer's Injection USP in 250 mL bag, Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-239-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V686000·2017-10-30

    Mitsubishi Mirage Recall: Air Bags May Fail to Deploy in Crash

    Mitsubishi is recalling 2014-2018 Mirage vehicles because the air bag system may disable itself due to sensor errors, increasing injury risk.

    Product
    MITSUBISHI — MITSUBISHI MIRAGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V683000·2017-10-30

    BMW Recalls 740,561 Vehicles for PCV Valve Fire Risk

    BMW is recalling 740,561 vehicles from 2007-2011 because a short circuit in the PCV valve heater can cause a fire.

    Product
    BMW — BMW 328I, 128I, X5, 530I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·18018·2017-10-30

    Polaris Recalls General Off-Highway Vehicles Due to Steering Shaft Hazard

    Polaris is recalling about 19,000 General side-by-side vehicles because the steering wheel shaft can shift and detach, creating a crash risk.

    Product
    Polaris General side-by-side recreational off-highway vehicles (ROVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V680000·2017-10-26

    Tremcar Recalls Hutchinson and Tremcar Trailers Due to Weak Rear Impact Guards

    Tremcar is recalling specific Hutchinson and Tremcar trailers because their rear impact guards were made with insufficiently strong aluminum alloy.

    Product
    HUTCHINSON — HUTCHINSON, TREMCAR 406 2 AXLE SEMI-TRAILER, 406 B-TRAIN PUP, 406 QUAD WAGON, 406 3 AXLE SEMI-TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V677000·2017-10-26

    Forest River Recalls 2017-2018 Rockwood and Flagstaff Travel Trailers

    Forest River is recalling 2017-2018 Rockwood and Flagstaff travel trailers because the slide room arm may damage the rear tire, increasing crash risk.

    Product
    FOREST RIVER — FOREST RIVER ROCKWOOD, FLAGSTAFF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0012-2018·2017-10-25

    RXQ Compounding Recalls Methylprednisolone Acetate Injection Due to Sterility Concerns

    RXQ Compounding LLC is recalling 945 vials of methylprednisolone acetate injection because autoclave parameters were incorrect, raising concerns about product sterility.

    Product
    methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Compounding, Athens, OH --- NDC: 70731-0936-10
    Category
    Drug
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0013-2018·2017-10-25

    Alprazolam Tablets Recalled for Unknown Impurity

    The Harvard Drug Group is recalling Alprazolam Tablets, 0.25 mg, due to an out-of-specification result for an unknown impurity.

    Product
    Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa 403 722 INDIA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; Distributed by: Major Pharmaceuticals, 17177 N.…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V676000·2017-10-25

    BMW Recalls 2006-2011 3 Series Vehicles for Fire Risk

    BMW is recalling 2006-2011 3 Series vehicles because heating and air conditioning wiring may overheat, increasing the risk of a fire.

    Product
    BMW — BMW 325XI, 323I, 325I, 328I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0028-2018·2017-10-25

    Death Wish Nitro Canned Cold Brew Coffee Recalled for Botulism Risk

    Death Wish Coffee Company is recalling 80,777 cans of Nitro Canned Cold Brew Coffee nationwide due to a potential for Clostridium Botulinum.

    Product
    Death Wish Nitro Canned Cold Brew Coffee 11 oz UPC: 851552005599
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0025-2018·2017-10-25

    Tampico Tropical Punch Recalled for Undeclared Milk Allergen

    Dean Foods is recalling 1,804 gallons of Tampico Tropical Punch in 1-gallon jugs due to undeclared milk. The product was distributed in Wisconsin, Illinois, and Indiana.

    Product
    Tampico Tropical Punch packaged in 1 gallon plastic jugs
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0011-2018·2017-10-25

    Symbio Muc Eye Recalled Due to Lack of Sterility Assurance

    Deserving Health International Corp is recalling Symbio Muc Eye eye drops because the product lacks assurance of sterility. The affected units were distributed throughout the United States.

    Product
    Symbio Muc Eye, 0.17 fl.oz. 5mL bottles, Manufactured for and distributed in the US b: Biological Health Group Corp. Bremerton, WA 98337. NDC 69711-125-61
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Food)·F-0026-2018·2017-10-25

    Vina Cafe Wake-Up Instant Coffee Mix Recalled for Undeclared Milk

    Hong Lee Trading is recalling Vina Cafe Wake-Up Instant Coffee Mix because it contains undeclared milk. The product was distributed in New York, New Jersey, and Connecticut.

    Product
    VINA CAF¿ WAKE-UP INSTANT COFFEE MIX in 18 PACK CARDBOARD BOXES (.6 oz packs); UPC: 8 934683 002759
    Category
    Food
    Distribution
    3 states
  • SevereNHTSA·17V670000·2017-10-24

    2018 Jeep Cherokee and Compass Recall for Oil Pump Housing Defect

    Chrysler is recalling 2018 Jeep Cherokee and Compass vehicles with 2.4L engines due to a cracked oil pump housing that can cause engine stalling and increase crash risk.

    Product
    JEEP — JEEP CHEROKEE, COMPASS
    Category
    Vehicle
    Distribution
    Distributed nationwide