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.

11926–11950 of 29163

  • SevereFDA (Drugs)·D-1348-2019·2019-06-19

    Torrent Pharma Recalls Children's Mapap Acetaminophen Liquid Due to Contamination

    Torrent Pharma is recalling Children's Mapap Acetaminophen Liquid due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Children's Mapap Acetaminophen Liquid, Fever reducer, Pain reliever, Alcohol free, Aspirin free, Cherry flavored, acetaminophen 160 mg per 5 mL, a) 4 FL. oz. (118 mL) bottle, NDC 0904-1985-20, b) One Pint (473 mL) bottle, NDC: 0904-1985-16, Distributed by Major Pharmaceuticals…
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1382-2019·2019-06-19

    Torrent Pharma Recalls Risperidone Oral Solution Due to Bacterial Contamination

    Torrent Pharma Inc. is recalling Risperidone Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 23155-317-51, Mfd for Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1358-2019·2019-06-19

    Torrent Pharma Recalls Cyproheptadine Syrup Due to Bacterial Contamination Risk

    Torrent Pharma is recalling Cyproheptadine Hydrochloride Syrup due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Cyproheptadine Hydrochloride Syrup Oral Solution, USP, 2mg/5mL, 473 mL (16 FL. oz.) bottle, NDC: 39328-044-16, Patrin Pharma, Skokie, IL 60076.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1323-2019·2019-06-19

    Pharm D Solutions Recalls B-Complex Injectable Vials Due to Sterility Concerns

    Pharm D Solutions, LLC is recalling specific lots of B-complex injectable vials due to a lack of sterility assurance. The affected product is distributed nationwide.

    Product
    B-complex (Thiamine 100mg, Riboflavin 2mg, Niacinamide 100 mg, Pyridoxine 2mg, Depanthenol 5mg) injectable, 10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846, NDC 69699-1611-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1362-2019·2019-06-19

    Torrent Pharma Recalls Acetic Acid Otic Solution Due to Bacterial Contamination

    Torrent Pharma is recalling specific lots of Acetic Acid Otic Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Acetic Acid Otic Solution, USP, 2%, Rx Only, 15 mL bottle, NDC: 64980-424-15, Manufactured by Bio-Pharm Inc., Levittown, PA 19057, Distributed by Rising Pharmaceuticals Ins Saddie Brook, NJ 07663.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1368-2019·2019-06-19

    Torrent Pharma Recalls Cough Syrup Due to Potential Bacterial Contamination

    Torrent Pharma Inc is recalling 249,744 bottles of Guaifenesin Syrup due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Cough Syrup (Guaifenesin Syrup, USP) 200 mg/10 mL, Alcohol free Non-Narcotic Expectorant, One Pint (473 mL) oz. bottle, NDC: 0536-0825-85, Distributed by Rugby Laboratories, Livonia, MI 48152.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1378-2019·2019-06-19

    Torrent Pharma Recalls Hemorrhoidal Suppositories Due to Bacterial Contamination

    Torrent Pharma is recalling 82,872 bottles of Hemorrhoidal Suppositories due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 Rectal Suppositories per carton, NDC: 0536-1389-12, Distributed by Rugby Laboratories, Livonia MI 48152 USA.
    Category
    Drug
    Distribution
    0 states
  • SevereNHTSA·19V467000·2019-06-18

    Isuzu Recalls 2018-2020 FTR and Chevrolet 6500XD for Steering Defect

    Isuzu is recalling 2018-2020 FTR and Chevrolet 6500XD vehicles because a steering stopper bolt jam nut may loosen, increasing the turning radius and crash risk.

    Product
    ISUZU — ISUZU, CHEVROLET FTR, 6500XD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V455000·2019-06-17

    Altec Recalls 2017-2018 Aerial Devices Due to Fastener Failure Risk

    Altec is recalling 2017-2018 aerial devices because fasteners securing the rotation bearing may break, potentially causing the pedestal to separate from the turntable.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V462000·2019-06-14

    Caterpillar Recalls 2015-2019 Progress Rail Sky Trim Hi-Rail Vehicles

    Caterpillar is recalling 2015-2019 Progress Rail Sky Trim Hi-Rail vehicles because a support plate may block driver visibility and the boom may detach from the cradle while in motion.

    Product
    PROGRESSIVE RAIL SERVICES — PROGRESSIVE RAIL SERVICES SKY TRIM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·069-2019·2019-06-14

    Ruiz Foods Recalls Bacon Breakfast Wraps Due to Foreign Matter Contamination

    Ruiz Foods is recalling approximately 246,514 pounds of frozen bacon breakfast wraps due to possible contamination with small rocks.

    Product
    Ruiz Food Products, Inc. — Ruiz Foods Products Inc. Recalls Bacon Breakfast Wrap Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·065-2019 EXP·2019-06-14

    Table 87 Frozen Recalls Pork and Beef Pizza Products Lacking Federal Inspection

    Table 87 Frozen, LLC is recalling frozen pork and beef pizza products produced without federal inspection. No adverse reactions have been reported.

    Product
    Table 87 Frozen, LLC — Table 87 Frozen, LLC Recalls Pork and Beef Pizza Products Produced without Benefit of Inspection
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V457000·2019-06-14

    Mercedes-Benz Recalls AMG GT Vehicles for Driveshaft Separation Risk

    Mercedes-Benz is recalling 2016-2017 AMG GT vehicles because the carbon-fiber driveshaft may separate, causing a loss of drive and increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG GT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V456000·2019-06-14

    Autocar Recalls 2013-2018 Xpeditor Vehicles for Drive Shaft Support Defect

    Autocar is recalling 2013-2018 Xpeditor vehicles because the drive shaft support cross member may fail, increasing crash risk. Dealers will install additional support brackets free of charge.

    Product
    AUTOCAR — AUTOCAR XPEDITOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V450000·2019-06-13

    Roadtrek Motorhomes Recalled for Weak Second-Row Seat Anchor Brackets

    Erwin Hymer is recalling 2013-2019 Roadtrek motorhomes because second-row seat anchor brackets may lack sufficient strength, increasing injury risk in a crash.

    Product
    ROADTREK — ROADTREK CS ADVENTUROUS, RS ADVENTUROUS, E-TREK, TS ADVENTUROUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19E040000·2019-06-13

    Cummins Recalls School Bus Hybrid Propulsion Control Units

    Cummins is recalling Vehicle Control Units for PowerDrive 7000 EV school buses because they may unexpectedly shut down, causing loss of drive and power steering.

    Product
    HYBRID PROPULSION SYSTEM recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V445000·2019-06-12

    Porsche Recalls 2019-2020 Models for Driveshaft Bolt Tightening Issue

    Porsche is recalling 2019 911 GT2 RS and 2020 911 Carrera S Coupe vehicles because driveshaft bolts may not be properly tightened, increasing crash risk.

    Product
    PORSCHE — PORSCHE 911 CARRERA, 911 GT2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·068-2019·2019-06-12

    Greener Pastures Chicken Recalls Raw Whole Poultry Produced Without Inspection

    Pasture Raised Foods, LLC is recalling raw whole poultry produced without federal inspection. The products were shipped to locations in Texas.

    Product
    Pasture Raised Foods, LLC Recalls Raw Whole Poultry Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1229-2019·2019-06-12

    OriGen ECMO Reinforced Dual Lumen Cannula Recalled for Potential Tube Disconnect

    OriGen Biomedical is recalling 66 units of ECMO Reinforced Dual Lumen Cannulas due to a risk of the clear tube disconnecting from the hub if clamped improperly.

    Product
    ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV32F
    Category
    Medical Device
    Distribution
    33 states
  • SevereFDA (Devices)·Z-1710-2019·2019-06-12

    BD Nexiva IV Catheter System Recalled for Septum Leak Risk

    Becton Dickinson is recalling 6,720 units of BD Nexiva Dual Port 20GA IV Catheter Systems due to a potential leak that could expose health care workers to blood.

    Product
    BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use in the peripheral vascular system Catalog Number: 383536
    Category
    Medical Device
    Distribution
    1 state