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.

10451–10475 of 29158

  • SevereFDA (Devices)·Z-0675-2020·2019-12-18

    Cognision Subject Kit Recalled for Potential B. cepacia Contamination

    Neuronetrix Solutions is recalling 3,108 units of the Cognision Subject Kit (Clinical Grade) due to potential contamination with Burkholderia cepacia.

    Product
    Cognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro Dot brand Wave Prep cups-electroconductive cream for use with external electrodes. Order No. D5000, Part No. PN-1720 - Product Usage: An electroconductive cream for use with external electrodes to reduce the i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0620-2020·2019-12-18

    SCA Pharmaceuticals Recalls Lidocaine Syringes Due to Foreign Material

    SCA Pharmaceuticals is recalling Lidocaine HCl 2% syringes because foreign material was found inside the vials.

    Product
    Lidocaine HCl 2% 5 mL, Syringe, Rx Only, SCA Pharmaceuticals 755 Rainbow Road Windsor, CT 08695 NDC 70004-0723-09
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0615-2020·2019-12-18

    Amneal Recalls Ranitidine Tablets Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling Ranitidine Tablets 150 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    RANITIDINE — RANITIDINE (RANITIDINE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0576-2020·2019-12-18

    Jubilant Cadista Recalls Amantadine Hydrochloride Tablets Due to Foreign Object

    Jubilant Cadista Pharmaceuticals is recalling 1,824 bottles of Amantadine Hydrochloride Tablets because a foreign object was found in a single tablet.

    Product
    Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA; NDC 59746-699-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0610-2020·2019-12-18

    Surgery Pharmacy Services Recalls 1,149 Bags of Memorial Central TPN

    Surgery Pharmacy Services is recalling 1,149 bags of Memorial Central TPN due to a lack of sterility assurance. The product was distributed in Georgia and Tennessee.

    Product
    Memorial Central TPN. Rx Only, Rx # specific and Patient Specific volumes. Mixed by Surgery Pharmacy Serv., 3908 TENN.AVE., SUITE F., CHATTANOOGA, TN., 37409,
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0586-2020·2019-12-18

    Fentanyl Citrate Recalled by Anazao Health Due to Fungal Contamination

    Anazao Health is recalling Fentanyl Citrate products because environmental sampling detected Talaromyces rotundus, a fungus, indicating a lack of processing controls.

    Product
    Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0614-2020·2019-12-18

    Amneal Recalls Ranitidine Syrup Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling Ranitidine Syrup Oral Solution because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0616-2020·2019-12-18

    Amneal Recalls Ranitidine Tablets Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling Ranitidine 300 mg tablets because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    RANITIDINE — RANITIDINE (RANITIDINE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Food)·F-0238-2020·2019-12-18

    Cain Food Industries Recalls Vitamin D2 Blend Due to Salmonella Risk

    Cain Food Industries is recalling 2,000 pounds of Vitamin D2 Blend due to possible Salmonella contamination. The product was distributed in seven states.

    Product
    Vitamin D2 Blend packaged in 50 lb. Multi-wall paper bag with polyethylene liner bags
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0590-2020·2019-12-18

    Anazao Health Recalls Hydromorphone, Baclofen, and Clonidine Combination Drugs

    Coast Quality Pharmacy, LLC dba Anazao Health is recalling Hydromorphone HCL, Baclofen, and Clonidine HCL combination drugs due to fungal contamination found during environmental sampling.

    Product
    Hydromorphone HCL and Baclofen and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0612-2020·2019-12-18

    Amneal Recalls Ranitidine Tablets Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling Ranitidine Tablets 150 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC 65162-253-10), c).180-count bottles (NDC 65162-253-18), d).500-count bottles (NDC 65162-253-50) and e)1000-count bottles (NDC 65162-253-11).
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0587-2020·2019-12-18

    Anazao Health Recalls Fentanyl and Morphine Compounded Drugs Due to Fungal Contamination

    Anazao Health is recalling compounded fentanyl and morphine drugs after environmental sampling detected Talaromyces rotundus fungi.

    Product
    Fentanyl Citrate and Bupivacaine HCl and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0587-2020·2019-12-18

    Cook CrossCath Support Catheter Recall Due to Manufacturing Error

    Cook Inc. is recalling 20 CrossCath Support Catheters because a manufacturing error may cause radiopaque marker bands to be too loose or too tight.

    Product
    CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For diagnostic and interventional vascular procedures.
    Category
    Medical Device
    Distribution
    20 states
  • SevereNHTSA·19T024000·2019-12-18

    Cooper Tire Recalls Specific Tires Due to Sidewall Defect

    Cooper Tire is recalling specific Evolution Tour, Mastercraft, Hercules, Starfire, and Stratus tires due to an improper sidewall component that may cause tire deflation and tread separation.

    Product
    TIRES:SIDEWALL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0578-2020·2019-12-18

    Anazao Health Recalls Clonidine and Morphine Sulfate Due to Fungal Contamination

    Coast Quality Pharmacy, LLC dba Anazao Health is recalling Clonidine HCL and Morphine Sulfate products due to the presence of Talaromyces rotundus fungi.

    Product
    Clonidine HCL and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V900000·2019-12-17

    Prevost Recalls 2020 Coach Buses Due to Driveshaft Bolt Tightening Issue

    Prevost is recalling 2020 X3-45 and H3-45 coach buses because driveshaft clamp bolts may not be properly tightened, which could cause loss of drive or a road hazard.

    Product
    PREVOST — PREVOST X3-45, H3-45 VIP, H3-45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V897000·2019-12-17

    Oliver Travel Trailers Recalls Elite II Models Due to Axle Bolt Issues

    Oliver Travel Trailers is recalling 2017-2019 Elite II travel trailers because improperly tightened axle bolts may affect braking or cause wheel detachment.

    Product
    OLIVER TRAVEL TRAILERS — OLIVER TRAVEL TRAILERS LEGACY ELITE II
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V894000·2019-12-16

    Maintainer Recalls 2019 Custom Body Heavy Rescue Vehicle for Shock Defect

    Maintainer is recalling one 2019 Custom Body Heavy Rescue vehicle because front shocks may separate, potentially causing a steering fluid leak and loss of power steering assist.

    Product
    MAINTAINER — MAINTAINER CUSTOM BODY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V893000·2019-12-16

    Foretravel Recalls 2020 Realm and iH45 Vehicles Due to Brake Defect

    Foretravel is recalling 2020 Realm and iH45 vehicles because a brake relay valve defect may increase stopping distance, raising crash risk.

    Product
    FORETRAVEL — FORETRAVEL REALM, IH-45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V896000·2019-12-16

    Mack Trucks Recalls 2020 Models for Steering Drag Link Defect

    Mack Trucks is recalling 2020 Anthem, Granite, and Pinnacle vehicles because steering drag link connections may be improperly installed, risking loss of steering control.

    Product
    MACK — MACK ANTHEM (AN), PINNACLE (CHU), GRANITE (GR)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V891000·2019-12-13

    Forest River Recalls 2020 Motorhomes Due to Trailer Hitch Bolt Issue

    Forest River is recalling 2020 Georgetown and FR3 motorhomes because trailer hitch bolts may not be properly tightened, posing a crash risk while towing.

    Product
    FOREST RIVER — FOREST RIVER FR3, GEORGETOWN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V890000·2019-12-12

    Maintainer Recalls 2019 Custom Body Heavy Rescue Vehicle for Brake Defect

    Maintainer is recalling one 2019 Custom Body Heavy Rescue vehicle because a brake relay valve defect may cause extended stopping distances, increasing crash risk.

    Product
    MAINTAINER — MAINTAINER CUSTOM BODY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V888000·2019-12-12

    GM Recalls 2019-2020 Silverado and Sierra Trucks for Electrical Fire Risk

    General Motors is recalling 2019-2020 Chevrolet Silverado 1500 and GMC Sierra 1500 trucks because excessive glue on the battery cable may cause electrical arcing, stalling, or fire.

    Product
    GMC — GMC, CHEVROLET SIERRA 1500, SILVERADO 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide