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.

21176–21200 of 32121

  • SevereUSDA FSIS·145-2015·2015-12-03

    K. Heeps Recalls Pureed Meat Products for Undeclared Allergens

    K. Heeps is recalling approximately 152,010 pounds of pureed roast beef products because they may contain undeclared milk and wheat allergens.

    Product
    K. Heeps Inc — K. Heeps Recalls Pureed Meat Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0265-2016·2015-12-02

    TN Juice Bar Recalls Refine 3-Day Cleanse Juice Kit Nationwide

    TN Juice Bar is recalling 137 units of the Refine 3-Day Cleanse juice kit nationwide due to unpasteurized juice with elevated pH levels and unlabeled almond milk.

    Product
    Refine 3-Day Cleanse, a juice kit that contains Lean Green, 16 oz (6 bottles), Beet It, 16 oz (6 bottles), Almond Milk, 8 oz (3 bottles) and Wheat grass juice, 8 oz (2 bottles)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V812000·2015-12-02

    Ford Recalls 2013 Vehicles for Fuel Delivery Module Fire Risk

    Ford is recalling 2013 Explorer, Taurus, Flex, Lincoln MKS, and MKT vehicles because a cracked fuel delivery module may leak fuel and cause a fire.

    Product
    FORD — FORD, LINCOLN TAURUS, MKT, FLEX, MKS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0337-2016·2015-12-02

    NxStage Hemodialysis System Recalled for Ultrafiltration Volume Software Error

    NxStage Medical is recalling 7 units of the System One S Cycler hemodialysis system due to a software error that may cause the pump to continue removing fluid after the target volume is reached.

    Product
    NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0223-2016·2015-12-02

    Tower Cafe Frozen Cookie Dough Recalled for Undeclared Allergens

    Tower Cafe is recalling 656 tubs of M&M Old Fashioned Gourmet Cookie Dough sold in Oklahoma due to undeclared milk, soy, wheat, and yellow #5.

    Product
    M&M Old Fashioned Gourmet Cookie Dough NET WT. 3 lb. (48 oz.) Distributed By: Tower Cafe, Okarche, OK 73762 packaged in plastic tub.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0324-2016·2015-12-02

    Green Organic Vegetables Recalls Nature's Promise Edamame for Undeclared Soy

    Green Organic Vegetables is recalling Nature's Promise Organic Shelled Edamame because the product contains undeclared soy. The frozen product was distributed to supermarkets in 12 states.

    Product
    Natures Promise Organic Shelled Edamame, 16 oz., UPC 68826712764. Product is frozen.
    Category
    Food
    Distribution
    12 states
  • SevereNHTSA·15V802000·2015-11-30

    Yamaha Recalls 2015 YZF-R1 Motorcycles Due to Transmission Gear Failure

    Yamaha is recalling 2,921 model year 2015 YZF-R1 motorcycles because transmission gears may fail, potentially causing the transmission to lock up and increasing the risk of a crash.

    Product
    YAMAHA — YAMAHA YZFR1MF, YZFR1MFC, YZFR1, YZFR1C
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V803000·2015-11-30

    Newmar Recalls 2014-2015 Motorhomes Due to Cargo Door Lock Fire Risk

    Newmar is recalling specific 2014-2015 motorhomes because cargo door lock actuators may overheat and melt, increasing the risk of a fire.

    Product
    NEWMAR — NEWMAR VENTANA, DUTCH STAR, MOUNTAIN AIRE, ESSEX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V804000·2015-11-30

    Mack Trucks Recalls 2010-2016 Granite Trucks Due to Brake Imbalance

    Mack Trucks is recalling 2010-2016 Granite 4X2 trucks because a brake imbalance may cause rear brakes to overheat, increasing the risk of tire blowouts or wheel-end fires.

    Product
    MACK — MACK GRANITE (GU)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·144-2015·2015-11-27

    Mama Lina's Recalls Beef and Chicken Empanadas Produced Without Inspection

    Mama Lina's Inc. is recalling approximately 1,754 pounds of beef and chicken empanada products produced without federal inspection. No adverse reactions have been reported.

    Product
    Mama Lina's Inc. Recalls Beef and Chicken Empanada Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0267-2016·2015-11-25

    US Compounding Recalls Methylprednisolone/Lidocaine Vials Due to Sterility Concerns

    US Compounding Inc is recalling 11,363 vials of Methylprednisolone/Lidocaine due to deficient practices that may impact sterility assurance.

    Product
    Methylprednisolone/Lidocaine (40 mg/mL/1%) 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3122-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0245-2016·2015-11-25

    US Compounding Recalls Cyclo/PE/Tropic/Ketor Ophthalmic Drops for Sterility Concerns

    US Compounding Inc is recalling 1,198 bottles of compounded ophthalmic drops nationwide due to deficient practices that may impact sterility assurance.

    Product
    Cyclo/PE/Tropic/Ketor (1%/2.5%/1%/0.5%), 10 mL Opthalmic dropper bottle, For topical ophthalmic use, Rx. only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3044-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0288-2016·2015-11-25

    US Compounding Recalls Tri-Mix Vials Due to Sterility Assurance Concerns

    US Compounding Inc is recalling 797 vials of Tri-Mix 30/1/10 injection due to deficient practices that may impact sterility assurance.

    Product
    Tri-Mix 30/1/10 (papaverine HCL USP 30 mg/ phentolamine mesylate USP 1 mg/ alprostadil USP 10 mcg/mL), 5 mL Multi-Dose Vial, For Penile Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3256-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0345-2016·2015-11-25

    Downing Labs Recalls Procaine Injectables Due to Sterility Concerns

    Downing Labs, LLC is recalling 881 vials of Procaine Injectables because the company cannot ensure the product is sterile. The affected vials were distributed in the US and 17 other countries.

    Product
    Procaine Injectables 20mg/mL and 2%, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-306-2016·2015-11-25

    Essential Wellness Pharma Recalls HCG Injections Due to Sterility Concerns

    Essential Wellness Pharma is recalling 49 vials of HCG 1000 Units/mL injections nationwide due to poor sterile production practices that compromise sterility assurance.

    Product
    HCG 1000 Units/mL SUB-Q Injection, packaged in a)1.5 mL, b) 2 mL, c) 2.4 mL, d) 4 mL, e) 6 mL, f) 7.5 mL, g) 8 mL, and h) 9 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0359-2016·2015-11-25

    Downing Labs Recalls DMPS Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling DMPS Injectable vials because the company cannot ensure the product is sterile.

    Product
    DMPS Injectable, 50mg/mL, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0353-2016·2015-11-25

    Downing Labs Recalls Phosphatidylcholine Injection Due to Sterility Concerns

    Downing Labs is recalling specific lots of Phosphatidylcholine/Deoxycholic Acid Injection because the company cannot assure the product's sterility.

    Product
    Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 10/4.75%; Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 5/2.5%; Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 5/4.2%, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0293-2016·2015-11-25

    US Compounding Recalls Voriconazole Eye Drops Due to Sterility Concerns

    US Compounding Inc is recalling specific lots of Voriconazole eye drops because deficient practices may have compromised sterility assurance.

    Product
    Voriconazole Solution (1%(10 mg/mL), 15 mL dropper bottle; For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-2815-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0356-2016·2015-11-25

    Downing Labs Recalls Chromium Injectable Due to Sterility Assurance Concerns

    Downing Labs, LLC is recalling all lots of Chromium Injectable, 200mg/mL, 30mL vials because the product lacks assurance of sterility.

    Product
    Chromium Injectable, 200mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0263-2016·2015-11-25

    US Compounding Recalls Medroxyprogesterone/Lidocaine Vials Due to Sterility Concerns

    US Compounding Inc is recalling 439 vials of Medroxyprogesterone/Lidocaine due to deficient practices that may impact sterility assurance.

    Product
    MedroxyPROGESTERone/Lidocaine (150 mg/mL/1%) 10 mL Multi-Dose Vial, For IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3113-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0276-2016·2015-11-25

    US Compounding Recalls Phenylephrine PF Syringes Due to Sterility Concerns

    US Compounding Inc is recalling 14,580 vials of Phenylephrine PF IV syringes nationwide due to deficient practices that may impact sterility assurance.

    Product
    Phenylephrine PF (1 mg/10 mL), 10 mL Single Use Syringe, For IV Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3159-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0261-2016·2015-11-25

    US Compounding Recalls Lidocaine Syringes Due to Sterility Assurance Concerns

    US Compounding Inc is recalling 7,320 syringes of Lidocaine 1% PF for IV injection because deficient practices may have impacted sterility assurance.

    Product
    Lidocaine 1% PF(100 mg/10 mL),10 mL Single Use Syringe, For IV Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3099-07
    Category
    Drug
    Distribution
    Distributed nationwide