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.

21351–21375 of 32121

  • SevereFDA (Drugs)·D-0279-2016·2015-11-25

    US Compounding Recalls Prednisolone Eye Drops Due to Sterility Concerns

    US Compounding Inc is recalling Prednisolone Sodium Phosphate eye drops due to deficient practices that may impact sterility assurance.

    Product
    Prednisolone Sodium Phosphate PF Solution (1%) in 15 mL dropper bottle; For Topical Ophthalmic Use, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0360-2016·2015-11-25

    Downing Labs Recalls Magnesium Sulfate Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling 160 vials of Magnesium Sulfate Injectable because the company cannot assure the sterility of the product.

    Product
    Magnesium Sulfate Injectable, 14.28%, 7mL 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-0259-2016·2015-11-25

    US Compounding Recalls Choline Chloride Inositol Cyanocobalamin Injection Vials

    US Compounding Inc is recalling 103 vials of a compounded injection due to deficient practices that may impact sterility assurance.

    Product
    Choline chloride 50 mg/mL, Inositol 50 mg/mL Cyanocobalamin 1000 mcg/mL, 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3294-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0255-2016·2015-11-25

    US Compounding Recalls Hyaluronic Acid Syringes Due to Sterility Concerns

    US Compounding Inc is recalling 5,118 syringes of Hyaluronic Acid/Lidocaine PF due to deficient practices that may impact sterility assurance.

    Product
    Hyaluronic Acid/Lidocaine PF (20 mg/1%), 2 mL Single-Use Syringe , For Intra-Articular Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3087-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0220-2016·2015-11-25

    Fresco Fresh Banana Strawberry Yogurt Parfait Recalled for Undeclared Almonds

    Del Monte is recalling 544 units of Fresco Fresh Banana Strawberry Yogurt Parfait because the product may contain undeclared almonds.

    Product
    Fresco Fresh Banana Strawberry Yogurt Parfait Net Wt. 6.5 oz. packaged in clear plastic tub.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0237-2016·2015-11-25

    Kronos Foods Recalls Sample Assortment for Potential Metal Fragments

    Kronos Foods is recalling a 4-pound Sample Assortment of baked goods due to the potential for metal fragments. The recall covers 2 cases distributed to specific US states and one Canadian consignee.

    Product
    Sample Assortment Net WT 4 lbs. (1.82 kg) total weight of five trays bundled together. 38-68 pieces per tray Item number 11904 Manufactured by Kronos Foods Corporation, Madera, CA
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Drugs)·D-0372-2016·2015-11-25

    Downing Labs Recalls Piracetam Injection Due to Sterility Assurance Concerns

    Downing Labs, LLC is recalling Piracetam Injection, 200mg/mL, 10mL vials due to a lack of assurance of sterility. The recall covers all lots distributed nationwide and internationally.

    Product
    Piracetam Injection, 200mg/mL,10mL 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-332-2016·2015-11-25

    Essential Wellness Pharma Recalls TRIMIX #1 Injection Due to Sterility Concerns

    Essential Wellness Pharma is recalling TRIMIX #1 Injection vials because poor production practices may have compromised the sterility of the compounded sterile preparations.

    Product
    TRIMIX #1 Injection, 4.2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0153-2016·2015-11-25

    Kar's Sweet n' Salty Mix Recalled for Possible Glass Contamination

    Kar Nut Products Company is recalling 208,008 bags of Kar's Sweet n' Salty Mix due to the possibility of very small pieces of glass in the product.

    Product
    Kar's Sweet n' Salty Mix 2 oz. flexible film bags. 72 bags per case.
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Devices)·Z-0285-2016·2015-11-25

    Prism Medical P-300 Portable Consumer Lift Recalled for Drive Shaft Failure

    ErgoSafe Products is recalling 1,721 Prism Medical P-300 Portable Consumer Lifts because the drive shaft and over speed arm may fail, potentially causing a patient to fall.

    Product
    Prism Medical P-300 Portable Consumer Lift; PN 303050, 303050R, and 303051; weight specification 300 lbs. /136 kg.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0292-2016·2015-11-25

    US Compounding Recalls Vitamin D3 Vials Due to Sterility Concerns

    US Compounding Inc is recalling 55 vials of Vitamin D3 in Olive Oil due to deficient practices that may impact sterility assurance.

    Product
    Vitamin D3 in Olive Oil (50,000 IU/mL) 30 mL vial, For IM Use only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3277-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0296-2016·2015-11-25

    Fresenius Modified Mixer Motor Recalled Due to Fire Risk

    Fresenius Medical Care is recalling 992 Modified Mixer Motors for 132 Gallon Dissolution Units because they lack full thermal protection, posing a fire hazard.

    Product
    Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075. For Use in the Preparation of acid concentrate for hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0256-2016·2015-11-25

    US Compounding Recalls Hyaluronic Acid Syringes Due to Sterility Concerns

    US Compounding Inc is recalling 531 hyaluronic acid and lidocaine syringes because deficient practices may have impacted sterility assurance.

    Product
    Hyaluronic Acid/Lidocaine PF (60 mg/2%), 3 mL Single Use Syringe, For Intra-Articular Injection , Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3249-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V796000·2015-11-24

    Mercedes-Benz Recalls 2015 S550E Hybrid Vehicles Due to Charger Defect

    Mercedes-Benz is recalling 2015 S550E Hybrid vehicles because a defective onboard charger may cause the car to unexpectedly shift to park, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ S550E
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V792000·2015-11-24

    Mercedes-Benz Recalls 2014 E350 Sedans for Fuel Line Fire Risk

    Mercedes-Benz is recalling 809 model year 2014 E350 sedans because a fuel feed line defect may cause a leak or disconnection, increasing the risk of fire or a crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ E350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·16045·2015-11-24

    SalesOne Recalls Light Up Ear Plug Jewelry Due to Burn Hazard

    SalesOne is recalling light-up ear plug jewelry sold at Spencer Gifts because battery acid can leak and cause burns. Consumers should stop wearing the product and contact SalesOne for a refund or replacement.

    Product
    Light up ear plug jewelry
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V791000·2015-11-24

    Wabash National Van Trailers Recalled for Brake Caliper Bolt Defect

    Wabash is recalling 2013-2015 Van Trailers because brake caliper bolts may not be tightened, risking caliper detachment and reduced braking.

    Product
    WABASH NATIONAL — WABASH NATIONAL VAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V794000·2015-11-24

    Subaru Recalls 2016 Legacy and Outback for Drive Shaft Separation Risk

    Subaru is recalling 2016 Legacy and Outback vehicles because improperly tightened nuts may allow the drive shaft to separate, potentially causing a fuel leak and fire.

    Product
    SUBARU — SUBARU OUTBACK, LEGACY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V790000·2015-11-24

    VT Hackney Recalls 2015 Kidron Refrigerated Trailers Due to Brake Defect

    VT Hackney is recalling certain 2015 Kidron Refrigerated Trailers because improperly tightened caliper bolts may allow the brake caliper to detach, reducing braking performance.

    Product
    KIDRON — KIDRON REFRIGERATED TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V789000·2015-11-24

    Ford Recalls 2016 F-650 Trucks Due to Incorrect Steering Column

    Ford is recalling 2016 F-650 trucks built between July 29 and September 3, 2015, because an incorrect steering column may cause the park pawl to fracture, allowing the vehicle to move unexpectedly.

    Product
    FORD — FORD F-650 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V793000·2015-11-24

    Ford Recalls 2010-2011 Fusion and Mercury Milan for Fuel Leak Risk

    Ford is recalling 2010-2011 Fusion and Mercury Milan vehicles because fuel vapor canister purge valves may fail, causing fuel tank cracks and leaks that increase fire risk.

    Product
    MERCURY — MERCURY, FORD MILAN, FUSION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V781000·2015-11-23

    Strick Dry Freight Van Trailer Recall for Rear Impact Guard Defect

    Strick Trailers is recalling 1998-2005 Dry Freight Van Trailers because rear impact guards may fail to prevent vehicles from sliding underneath during a crash.

    Product
    STRICK — STRICK DRY FREIGHT VAN TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V782000·2015-11-23

    BMW Recalls M3 and M4 Vehicles for Driveshaft Defect

    BMW is recalling 2015-2016 M3 and M4 vehicles because a driveshaft slip-joint may lack grease, potentially causing loss of power and increasing crash risk.

    Product
    BMW — BMW M3, M4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V776000·2015-11-20

    Navistar Recalls 2013-2014 International Trucks for Accelerator Pedal Defect

    Navistar is recalling 2013-2014 International trucks because a faulty accelerator pedal sensor can cause high engine idle, increasing crash risk on downgrades.

    Product
    INTERNATIONAL — INTERNATIONAL TRANSTAR, DURASTAR, WORKSTAR, LONESTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide