The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. 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.

10926–10950 of 29159

  • SevereFDA (Drugs)·D-0276-2020·2019-11-13

    Red Mountain Compounding Recalls S-MIC 25/50/50 B12A Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of S-MIC 25/50/50 B12A 5mg/ml solution due to a lack of assurance of sterility.

    Product
    S-MIC 25/50/50 B12A 5MG/ML MDV SOLN; Rx Only, 30ml Glass vial, Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0274-2020·2019-11-13

    Red Mountain Compounding Pharmacy Recalls S-MIC/B12/Carnitine Injection for Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of S-MIC/B12(C)/Carnitine injection due to a lack of assurance of sterility. The product was distributed nationwide in the USA.

    Product
    S-MIC/B12(C)/CARNITINE 25/50/50/1/50MG/ML MDV INJ; Lot #: S07172019DT@10, Exp 1/17/20; S02142019DH@01, Exp 8/14/19; S03192019DT@04,Exp 9/19/19; " S04162019DT@15, Exp 10/16/19; S07232019DH@04, Exp 1/23/20; S02142019DH@01, Exp 8/14/19; S04162019DT@15, Exp 9/9/19; s0709
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0271-2020·2019-11-13

    Red Mountain Compounding Recalls S-Methylcobalamin Injections for Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-Methylcobalamin injections due to a lack of assurance of sterility. The affected vials were distributed nationwide.

    Product
    S-METHYLCOBALAMIN 10,000MCG/ML MDV INJ; 30ML glass vial, Rx Only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0349-2020·2019-11-13

    ICU Medical Recalls Lactated Ringer's Injection Due to Particulate Matter

    ICU Medical is recalling 389,808 bags of Lactated Ringer's Injection due to the presence of particulate matter. The affected product was distributed nationwide.

    Product
    LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7953-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0247-2020·2019-11-13

    Red Mountain Compounding Recalls S-Pyridoxine HCL Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-Pyridoxine HCL (B6) vials because the product lacks assurance of sterility.

    Product
    S-PYRIDOXINE HCL (B6) 100MG/ML MDV, Rx Only, 30ml glass vial. Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0184-2020·2019-11-13

    Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity

    Dr. Reddy's Laboratories is recalling Ranitidine Tablets 150 mg because of the presence of the NDMA impurity.

    Product
    Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 63868-480-24), b.) 50-count bottles (NDC 63868-480-50) (CDMA) OTC
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0178-2020·2019-11-13

    Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity

    Dr. Reddy's Laboratories is recalling Ranitidine Tablets 75 mg because of the presence of NDMA impurity. The product was distributed to major distributors throughout the United States.

    Product
    Ranitidine Tablets, USP 75 mg, NDC 57896-715 (GeriCare) OTC.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0171-2020·2019-11-13

    Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity

    Dr. Reddy's Laboratories is recalling Walmart-branded Ranitidine Tablets 150 mg because of the presence of the NDMA impurity.

    Product
    Ranitidine Tablets, USP 150 mg, a.) 65 count bottles (NDC 49035-404-61) b.) 130 count bottles (NDC 49035-404-13) c.) 220 count bottles (NDC 49035-404-65) (Walmart) OTC
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0182-2020·2019-11-13

    Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity

    Dr. Reddy's is recalling Ranitidine Tablets because an NDMA impurity was detected. Consumers should stop using the product and return it to the pharmacy.

    Product
    RANITIDINE — RANITIDINE (RANITIDINE)
    Category
    Drug
    Distribution
    0 states
  • SevereNHTSA·19V806000·2019-11-12

    Aston Martin Recalls DB11, Vantage, and DBS Superleggera for Air Bag Defect

    Aston Martin is recalling 2018-2019 DB11, Vantage, and DBS Superleggera vehicles because passenger air bag fasteners may not be tightened properly, increasing injury risk in a crash.

    Product
    ASTON MARTIN — ASTON MARTIN DB11, DBS SUPERLEGGERA, VANTAGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V809000·2019-11-12

    Ford Recalls 2016-2017 Lincoln MKX Vehicles for Battery Cable Fire Risk

    Ford is recalling 2016-2017 Lincoln MKX vehicles with 3.7L engines because the battery cable harness may contact a bracket, causing a short circuit and increasing fire risk.

    Product
    LINCOLN — LINCOLN MKX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V805000·2019-11-12

    Ford Recalls 2019-2020 F-150 Trucks for Battery Cable Fastener Issue

    Ford is recalling 2019-2020 F-150 vehicles because a battery cable fastener may loosen, potentially causing engine stalling, loss of braking or steering assist, or fire.

    Product
    FORD — FORD F-150
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V804000·2019-11-08

    Mitsubishi i-MiEV Recall for Brake Vacuum Pump Corrosion Risk

    Mitsubishi is recalling 2012-2017 i-MiEV vehicles because water may corrode the brake vacuum pump, causing a loss of braking assist and increasing crash risk.

    Product
    MITSUBISHI — MITSUBISHI I-MIEV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·110-2019·2019-11-08

    You Chang Trading Recalls Raw Tilapia Fillets Lacking Inspection

    You Chang Trading, Inc. is recalling raw fish fillets labeled as Tilapia that were not presented for FSIS import re-inspection. The products were distributed in four states.

    Product
    You Chang Trading, Inc. Recalls Siluriformes Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    4 states
  • SevereNHTSA·19V807000·2019-11-08

    Nissan Recalls Murano, Maxima, Pathfinder, QX60 for Brake Fire Risk

    Nissan is recalling 391,479 vehicles because brake fluid may leak onto an electrical circuit board, creating a fire risk.

    Product
    NISSAN — NISSAN, INFINITI MURANO, QX60, MAXIMA, PATHFINDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V803000·2019-11-07

    Freightliner Cascadia Recall for Brake Chamber Clearance Defect

    Daimler Trucks North America is recalling 2020 Freightliner Cascadia vehicles because brake chambers may contact the frame rail, potentially causing detachment and reduced braking.

    Product
    FREIGHTLINER — FREIGHTLINER CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V800000·2019-11-06

    Mercedes-Benz Sprinter Recall for Front Seat Weld Defect

    Daimler Vans USA is recalling 2019 Mercedes-Benz and Freightliner Sprinter vans because a front seat weld may break in a crash, increasing injury risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ, FREIGHTLINER SPRINTER 4500, SPRINTER 2500, SPRINTER 1500, SPRINTER 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0221-2020·2019-11-06

    Thoratec CentriMag Motor Recalled Due to Electromagnetic Interference Issues

    Thoratec is recalling CentriMag Acute Circulatory Support System motors due to reports of motor and pump issues caused by electromagnetic interference.

    Product
    CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·108-2019·2019-11-06

    Simmons Prepared Foods Recalls Poultry Products Due to Metal Contamination

    Simmons Prepared Foods is recalling approximately 2.07 million pounds of poultry products that may contain metal. The products were shipped to institutions in eight states.

    Product
    Simmons Prepared Foods, Inc. — Simmons Prepared Foods, Inc. Recalls Poultry Products due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Devices)·Z-0222-2020·2019-11-06

    MedComp C3 Wave App Recalled Due to ECG Display Failure

    Medical Components, Inc dba MedComp is recalling the C3 Wave App v. 2.0.5 because it malfunctions on iOS 12, preventing ECG display during PICC procedures.

    Product
    C3 Wave App, v. 2.0.5
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Drugs)·D-0158-2020·2019-11-06

    Innoveix Recalls Lyophilized Human Chorionic Gonadotropin Due to Sterility Concerns

    Innoveix Pharmaceuticals is recalling 413 vials of Lyophilized Human Chorionic Gonadotropin 5,000 USP Units due to a lack of sterility assurance.

    Product
    Lyophilized Human Chorionic Gonadotropin 5,000 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0160-2020·2019-11-06

    Innoveix Recalls Lyophilized Human Chorionic Gonadotropin Due to Sterility Concerns

    Innoveix Pharmaceuticals is recalling 290 vials of Lyophilized Human Chorionic Gonadotropin 5,500 USP Units due to a lack of sterility assurance.

    Product
    Lyophilized Human Chorionic Gonadotropin 5,500 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0201-2020·2019-11-06

    Ethicon Recalls ECHELON FLEX Staplers Due to Anvil Defect

    Ethicon Endo-Surgery Inc is recalling 255 units of the ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler because an out-of-specification anvil may cause malformed staples and compromised staple lines.

    Product
    ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A
    Category
    Medical Device
    Distribution
    Distributed nationwide