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.

11626–11650 of 29163

  • SevereFDA (Drugs)·D-1654-2019·2019-08-14

    RXQ Compounding Recalls Edetate Disodium Due to Sterility Concerns

    RXQ Compounding LLC is recalling Edetate Disodium 150mg/mL PFV vials because the product lacks assurance of sterility.

    Product
    Edetate Disodium150mg/mL PFV, 10 ML per Vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731-0934-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1698-2019·2019-08-14

    RXQ Compounding Recalls Procaine HCL 8% Injectable Due to Sterility Concerns

    RXQ Compounding LLC is recalling Procaine HCL 8% Injectable due to a lack of assurance of sterility. The recall covers all lots within expiry distributed nationwide.

    Product
    PROCAINE HCL 8% (PFV) INJECTABLE, 10ML PER VIAL, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0970-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1639-2019·2019-08-14

    RXQ Compounding Recalls Buffered Lidocaine HCL 1% Injection Solution

    RXQ Compounding LLC is recalling Buffered Lidocaine HCL 1% Injection Solution due to a lack of assurance of sterility.

    Product
    BUFFERED LIDOCAINE HCL 1% INJECTION SOLUTION (PF), 10ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0139-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1648-2019·2019-08-14

    RXQ Compounding Recalls Diazepam Injection Due to Sterility Concerns

    RXQ Compounding LLC is recalling diazePAM 5 MG/ML Injection Solution because the product lacks assurance of sterility.

    Product
    diazePAM 5 MG/ML INJECTION SOLUTION (C-IV) SYR, 2 ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0929-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1642-2019·2019-08-14

    RXQ Compounding Recalls Calcium Glucunate Injection Due to Sterility Concerns

    RXQ Compounding LLC is recalling Calcium Glucunate 5% Injection Solution because the FDA determined there is a lack of assurance of sterility.

    Product
    CALCIUM GLUCONATE 5% INJECTION SOLUTION (MDV), 20 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0903-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1695-2019·2019-08-14

    RXQ Compounding Recalls Prednisolone and Moxifloxacin Ophthalmic Solution

    RXQ Compounding LLC is recalling Prednisolone 1% and Moxifloxacin 0.5% ophthalmic solution due to a lack of assurance of sterility.

    Product
    PREDNISOLONE 1%, MOXIFLOXACIN 0.5% OPHTH SOL, 5ML per dropper bottle, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0109-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1669-2019·2019-08-14

    RXQ Compounding Recalls Ketamine Injection Due to Sterility Concerns

    RXQ Compounding LLC is recalling Ketamine 50 mg/mL injection solution because the product lacks assurance of sterility.

    Product
    KETAMINE 50 MG/ML (NPV) INJECTION SOLUTION (C-III), 10 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0173-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1674-2019·2019-08-14

    RXQ Compounding Recalls Magnesium Chloride Injection Due to Sterility Concerns

    RXQ Compounding LLC is recalling Magnesium Chloride Hexahydrate 20% Injection Solution because the product lacks assurance of sterility.

    Product
    MAGNESIUM CHLORIDE HEXAHYDRATE (MDV) 20% INJ SOLN, 50 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0977-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2071-2019·2019-08-14

    St Jude Medical Recalls 47 Ellipse VR Implantable Cardioverter Defibrillators

    St Jude Medical is recalling 47 Ellipse VR ICDs worldwide due to damaged aluminum wires that may prevent the delivery of high-voltage therapy.

    Product
    ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1693-2019·2019-08-14

    RXQ Compounding Recalls PHO-TID-CHOL Injection Due to Sterility Concerns

    RXQ Compounding LLC is recalling PHO-TID-CHOL 50MG/DEOXYCHOLIC 42 MG/ML Injection due to a lack of assurance of sterility.

    Product
    PHO-TID-CHOL 50MG/ DEOXYCHOLIC 42 MG/ML INJ, 30 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0953-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1975-2019·2019-08-14

    Shirakiku Fish Cake Recalled for Undeclared Egg, Milk, and Shellfish

    Wismettac Asian Foods is recalling Shirakiku Fish Cake products due to possible undeclared egg, milk, and shellfish.

    Product
    Shirakiku FISH CAKE OHBAN AGE SK F; 20/ 150G; Net Wt. 5.29 oz. Keep Frozen, 1 pc UPC 074410925277 Distributed by Wismettac Asian Foods, Inc. Santa Fe Springs, CA
    Category
    Food
    Distribution
    38 states
  • SevereNHTSA·19V587000·2019-08-12

    Mercedes-Benz Recalls 2020 GLE and GLS Models for Fire Risk

    Mercedes-Benz is recalling 2020 GLE and GLS vehicles because incorrectly installed air conditioner drain hoses may cause water to enter the cabin, increasing the risk of fire.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLE 350, GLE 450, GLS 450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V590000·2019-08-12

    Ford Recalls 2015 Fusion and Lincoln MKZ for Seat Belt Cable Defect

    Ford is recalling 2015 Fusion and Lincoln MKZ vehicles because heat from seat belt pretensioners may cause anchor cables to fail, increasing injury risk in crashes.

    Product
    LINCOLN — LINCOLN, FORD MKZ, FUSION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V586000·2019-08-09

    Mercedes-Benz Recalls C300 and C43 Models for Battery Bracket Defect

    Mercedes-Benz is recalling 2018-2019 C300 and C43 AMG vehicles because the 12-volt battery bracket may be unsecured, risking terminal disconnection in a crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ C 300, AMG C43
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V584000·2019-08-09

    Mercedes-Benz Recalls 2019 S 450 for Air Bag Deployment Risk

    Mercedes-Benz is recalling one 2019 S 450 vehicle because improperly installed pillar covers may prevent side curtain air bags from deploying correctly during a crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ S 450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1951-2019·2019-08-07

    Green Giant Cauliflower Crumbles Recalled for Listeria Risk

    Growers Express is recalling Green Giant Fresh Cauliflower Crumbles due to a positive Listeria monocytogenes test result from a retail sample.

    Product
    Green Giant Fresh Cauliflower Crumbles "Fried Rice" Blend; Chopped Cauliflower, Carrots, Broccoli and Onions. 1 lb. (16 oz.) (454 g) plastic bag UPC: 605806000744; Item number MXC101101 Perishable, Keep Refrigerated Distributed by Growers Marketing LLC, Salinas, CA
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Drugs)·D-1579-2019·2019-08-07

    ImprimisRx Recalls Subpotent Timolol-Dorzolamide-Latanoprost Ophthalmic Drops

    ImprimisRx NJ is recalling 246 bottles of Timolol-Dorzolamide-Latanoprost ophthalmic drops because the medication was found to be subpotent.

    Product
    Timolol- Dorzolamide- Latanoprost P-F (0.5/2.0/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRx NJ 1705 Route 46 West, Suite 4, Ledgewood, NJ 07852 (844) 446-6979
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2088-2019·2019-08-07

    Qiagen Filter-Tips Recalled for Leaking During Sample Preparation

    Qiagen Sciences LLC is recalling specific lots of Filter-Tips used with QIAsymphony instruments because a small percentage of tips are leaking.

    Product
    Filter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used with the QIAGEN QIAsymphony SP/AS Instruments (REF 9001297 and 9001301) REF: 997024 Used in sample preparation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1948-2019·2019-08-07

    Bento Sushi Recalls Pink Salmon Bowls Due to Metal Fragments

    Bento Sushi is recalling specific bowls of fully cooked pink salmon in teriyaki sauce because they may contain small metal fragments.

    Product
    Bento Express Fully Cooked Pink Salmon in a Teriyaki Sauce with Snow Peas, Garnished with Sesame Seeds. Served on Steamed White Rice, UPC Code: 670452710149
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1567-2019·2019-08-07

    Wise Pharmacy Recalls Acetylcysteine Otic Drops Due to Processing Controls

    Wise Pharmacy is recalling Acetylcysteine 2% Otic Drops due to a lack of processing controls. The product was distributed in Colorado, Texas, and Wyoming.

    Product
    Acetylcysteine 2% Otic Drop, 15 mL bottle, Rx only, Refrigerate, Compounded by Wise Pharmacy, Littleton, CO 80123.
    Category
    Drug
    Distribution
    3 states