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.

11801–11825 of 29163

  • SevereFDA (Drugs)·D-1428-2019·2019-07-03

    Premier Pharmacy Labs Recalls Succinylcholine Chloride Syringes for Sterility Concerns

    Premier Pharmacy Labs is recalling 1,721 syringes of Succinylcholine Chloride due to FDA findings of insufficient environmental controls and lack of sterility assurance.

    Product
    SUCCINYLcholine Chloride, 200mg/10mL (20mg/mL), 10mL Sterile Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-239-16, barcode 9 69623 23916 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1411-2019·2019-07-03

    Premier Pharmacy Labs Recalls Atropine Sulfate Injection Due to Sterility Concerns

    Premier Pharmacy Labs is recalling 745 syringes of Atropine Sulfate Injection because FDA inspections found insufficient environmental controls that may compromise sterility.

    Product
    Atropine Sulfate PF INJ, 0.8 mg/2 mL (0.4 mg/mL), 2mL Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-131-12, barcode 0 69623 13112 6.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1433-2019·2019-07-03

    Pramipexole Dihydrochloride Tablets Recalled for GMP Deviations and Cross-Contamination Risk

    American Health Packaging is recalling Pramipexole Dihydrochloride Tablets due to GMP deviations and a cleaning procedure failure that may have caused cross-contamination.

    Product
    Pramipexole Dihydrochloride Tablets, 0.5 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-974-95; NDC Carton: 68084-974-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1430-2019·2019-07-03

    Diphenhydramine Liquid Recalled for Potential Microbial Contamination

    H J Harkins Company is recalling Diphenhydramine HCL Liquid due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0123-03.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1422-2019·2019-07-03

    Premier Pharmacy Labs Recalls Neostigmine Methylsulfate Syringes for Sterility Concerns

    Premier Pharmacy Labs is recalling Neostigmine Methylsulfate syringes nationwide due to FDA findings of insufficient environmental controls and lack of sterility assurance.

    Product
    Neostigmine Methylsulfate, 5mg/5mL (1mg/mL), 5mL Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-234-15, barcode 5 69623 23415 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1488-2019·2019-07-03

    Parivar Dry Dates Recalled for High Sulfite Levels

    Parivar brand Dry Dates are being recalled due to high levels of sulfites. The product was distributed to retail grocery stores in Florida, North Carolina, Georgia, and South Carolina.

    Product
    Parivar brand Dry Dates (Kharek) Net Wt.14 oz. (400 g) Product of India Batch No. 127/BHBI
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1423-2019·2019-07-03

    Premier Pharmacy Labs Recalls Orphenadrine Citrate Syringes Due to Sterility Concerns

    Premier Pharmacy Labs is recalling 4,363 syringes of Orphenadrine Citrate Sterile Injectable Solution because FDA inspections found insufficient environmental controls that may compromise sterility.

    Product
    Orphenadrine Citrate Sterile Injectable Solution *Contains Sulfites*, 30mg/mL, 1mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-104-10, barcode 7 69623 10410 5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1888-2019·2019-07-03

    Ethicon ENSEAL X1 Curved Jaw Tissue Sealer Recalled for Bleeding Risk

    Ethicon Endo-Surgery Inc is recalling ENSEAL X1 Curved Jaw Tissue Sealers due to reported intraoperative bleeding.

    Product
    Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft PRODUCT CODE: NSLX125C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V513000·2019-07-03

    BMW Recalls Multiple Models for High Pressure Fuel Pump Defect

    BMW is recalling specific 2019-2020 models because a high pressure fuel pump may not be properly attached, potentially causing a fuel leak and fire risk.

    Product
    BMW — BMW X5, M5, M850I, X7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1413-2019·2019-07-03

    Premier Pharmacy Labs Recalls Chlorpromazine Injection Due to Sterility Concerns

    Premier Pharmacy Labs is recalling 824 vials of Chlorpromazine HCL Injection because an FDA inspection found insufficient environmental controls that may compromise sterility.

    Product
    ChlorproMAZINE HCL INJ, 25mg/mL, *Contains Sulfites*, 1mL in a 5mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-122-28, barcode 7 69623 12228 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1415-2019·2019-07-03

    Premier Pharmacy Labs Recalls Droperidol Syringes Due to Sterility Concerns

    Premier Pharmacy Labs is recalling 2,315 syringes of Droperidol Injectable Sterile Solution because FDA inspections found insufficient environmental controls and lack of sterility assurance.

    Product
    Droperidol Injectable Sterile Solution, 0.625mg/mL, 1mL in a 3mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-185-10, barcode 0 69623 18510 5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V508000·2019-07-02

    Altec Recalls 2018-2019 Aerial Devices Due to Fastener Failure Risk

    Altec is recalling 2018-2019 aerial devices because high-strength fasteners securing the pedestal to the turntable may fail, increasing the risk of injury or death.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V507000·2019-07-02

    Mercedes-Benz and Freightliner Sprinter Vehicles Recalled for Rear Window Safety Glass

    Daimler Vans USA is recalling 2018-2019 Mercedes-Benz and Freightliner Sprinter vans because rear side windows may be single-pane instead of laminated safety glass.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ, FREIGHTLINER SPRINTER 1500, SPRINTER 2500, SPRINTER 4500, SPRINTER 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V505000·2019-07-01

    Forest River Recalls 2019 Rockport Trucks Due to Brake Controller Wiring

    Forest River is recalling 2019 Rockport work trucks with optional trailer brake controllers due to improper wiring that may prevent trailer brakes from activating.

    Product
    FOREST RIVER — FOREST RIVER ROCKPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V500000·2019-06-27

    Honda and Acura Recall Vehicles for Air Bag Inflator Explosion Risk

    Honda is recalling specific 2005-2015 Acura and Honda vehicles because driver frontal air bag inflators may explode due to propellant degradation, posing a risk of serious injury or death.

    Product
    HONDA — HONDA, ACURA CR-Z, RL, CR-V, RIDGELINE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V501000·2019-06-27

    Honda Recalls Vehicles Due to Passenger Airbag Inflator Explosion Risk

    Honda is recalling specific Acura and Honda models because the passenger frontal airbag inflator may explode, potentially causing serious injury or death.

    Product
    ACURA — ACURA, HONDA MDX, ACCORD, CIVIC, CR-V
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V498000·2019-06-27

    2019 Ram Trucks Recalled for Diesel Fuel Line Leak Fire Risk

    Chrysler is recalling 2019 Ram 2500, 3500, 4500, and 5500 diesel trucks because fuel lines may leak, increasing the risk of a fire.

    Product
    RAM — RAM 5500, 4500, 3500, 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·19152·2019-06-27

    Apple Recalls 15-Inch MacBook Pro Laptops Due to Fire Hazard

    Apple is recalling about 432,000 15-inch MacBook Pro laptops because their batteries can overheat, posing a fire hazard.

    Product
    15-inch MacBook Pro laptop computers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V496000·2019-06-27

    Mazda Recalls 2016 MX-5 Vehicles for Detaching Skid Plate

    Mazda is recalling 2016 MX-5 vehicles because the skid plate and metal bracket may detach, creating a road hazard and increasing crash risk.

    Product
    MAZDA — MAZDA MX-5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V499000·2019-06-27

    Honda and Acura Recall Vehicles for Air Bag Inflator Defect

    Honda is recalling specific Acura and Honda models because driver frontal air bag inflators may explode, posing a risk of serious injury or death.

    Product
    ACURA — ACURA, HONDA MDX, ACCORD, CIVIC, CR-V
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V502000·2019-06-27

    Honda Recalls Vehicles for Passenger Air Bag Inflator Explosion Risk

    Honda is recalling specific 2006-2015 models because the passenger frontal air bag inflator may explode due to propellant degradation, posing a risk of serious injury or death.

    Product
    HONDA — HONDA, ACURA CR-V, ACCORD, TSX, PILOT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1786-2019·2019-06-26

    Monarch EndoTool IV Software Recalled for High Insulin Dosing Calculations

    Monarch Medical Technologies is recalling EndoTool IV software versions 1.8 through 1.10 because insulin dosing calculations were erroneously high.

    Product
    Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1750-2019·2019-06-26

    GE Healthcare Recalls Discovery ML DR PET/CT Systems Due to Table Stop Defect

    GE Healthcare is recalling 1,113 Discovery ML DR PET/CT systems because the table may stop moving without stopping X-ray exposure.

    Product
    Discovery Ml DR Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1749-2019·2019-06-26

    GE Healthcare Recalls Discovery ML PET/CT Systems Due to X-Ray Safety Defect

    GE Healthcare is recalling 1,113 Discovery ML PET/CT systems because the table may stop moving without stopping X-ray exposure.

    Product
    Discovery Ml Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
    Category
    Medical Device
    Distribution
    Distributed nationwide