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.

12776–12800 of 29186

  • SevereFDA (Drugs)·D-0501-2019·2019-02-27

    Torrent Pharma Recalls Losartan Potassium Tablets Due to NDEA Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium Tablets, USP, 100 mg, because FDA testing found the impurity N-nitrosodimethylamine (NDEA) above the interim acceptable daily intake level.

    Product
    LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 30-count (NDC: 13668-115-30), b) 90-count (NDC: 13668-115-90), c) 1000-count (NDC: 13668-115-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0503-2019·2019-02-27

    Torrent Pharma Recalls Losartan Potassium Tablets Due to NDEA Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium Tablets because FDA testing found the impurity NDEA above acceptable levels.

    Product
    LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-113-90), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0859-2019·2019-02-27

    Philips PageWriter TC30 Cardiograph Recall for Battery Overheating Risk

    Philips is recalling PageWriter TC30 cardiographs because end-of-life batteries may overheat, melt, or ignite, posing injury risks to patients and users.

    Product
    PageWriter TC30 w/ trolley Government Bundle, Product 860354, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0856-2019·2019-02-27

    Philips PageWriter TC20 Recall for Battery Overheating and Fire Risk

    Philips is recalling PageWriter TC20 devices because end-of-life batteries may overheat, melt the case, or ignite, posing a risk of injury.

    Product
    PageWriter TC20, Product 860332, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0861-2019·2019-02-27

    Philips PageWriter TC30 Cardiograph Recall for Battery Overheating Risk

    Philips is recalling PageWriter TC30 cardiographs because end-of-life batteries may overheat, melt, or ignite, posing injury risks to patients and users.

    Product
    PageWriter TC30 w/o trolley Government Bundle, Product 860355, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1014-2019·2019-02-27

    Sysco Recalls Fresh Pomegranates Due to Temperature Control Failure

    Sysco Charlotte is recalling fresh pomegranates because a cooler malfunction meant the fruit was not held at appropriate temperatures, potentially making it unsafe.

    Product
    PACKER POMEGRANATE FRESH¿
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0860-2019·2019-02-27

    Philips PageWriter TC50 Recall for Battery Overheating and Ignition Risk

    Philips is recalling PageWriter TC50 devices because end-of-life batteries may overheat, melt, or ignite, posing injury risks to patients and users.

    Product
    PageWriter TC50 Government Bundle, Product 860429, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0855-2019·2019-02-27

    Philips PageWriter TC30 ECG Devices Recalled for Overheating and Ignition Risk

    Philips is recalling PageWriter TC30 ECG devices because end-of-life batteries may overheat, melt the case, or ignite, posing injury risks to patients and users.

    Product
    PageWriter TC30, Product 860306, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0504-2019·2019-02-27

    Torrent Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium and Hydrochlorothiazide tablets because FDA labs found the impurity N-nitrosodimethylamine (NDEA) above acceptable levels.

    Product
    LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP, 100 mg/12.5 mg, a) 90-count bottle (NDC: 13668-117-90), b) 1000-count bottle (NDC: 13668-117-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0505-2019·2019-02-27

    Torrent Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium and Hydrochlorothiazide tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA) above acceptable levels.

    Product
    LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5 mg, a) 90-count bottle (NDC: 13668-116-90), b) 1000-count bottle (NDC: 13668-116-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0858-2019·2019-02-27

    Philips PageWriter TC Cardiograph Recall for Battery Overheating and Fire Risk

    Philips is recalling PageWriter TC70 cardiographs because end-of-life batteries may overheat, melt, or ignite, posing injury risks to patients and users.

    Product
    PageWriter TC70 w/o trolley Government Bundle, Product 860353, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0502-2019·2019-02-27

    Torrent Pharma Recalls Losartan Potassium Tablets Due to NDEA Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium Tablets, 50 mg, because FDA testing found the impurity N-nitrosodimethylamine (NDEA) above acceptable levels.

    Product
    LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count bottle (NDC: 13668-409-30), b) 90-count bottle (NDC: 13668-409-90), c) 1000-count bottle (NDC: 13668-409-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0509-2019·2019-02-27

    ICU Medical Recalls 0.9% Sodium Chloride Injection Due to CGMP Deviations

    ICU Medical Inc. is voluntarily recalling 475,320 bags of 0.9% Sodium Chloride Injection due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-09
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0853-2019·2019-02-27

    Philips PageWriter TC70 Cardiograph Recall for Battery Overheating Risk

    Philips is recalling PageWriter TC70 cardiographs because end-of-life batteries may overheat, melt the case, or ignite, posing a risk of injury to patients and users.

    Product
    PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·023-2019·2019-02-26

    McAllen Cold Storage Recalls Frozen Basa Fillets Lacking Inspection

    McAllen Cold Storage is recalling approximately 51,942 pounds of frozen Basa fillets imported from Vietnam that were not presented for import re-inspection.

    Product
    McAllen Cold Storage, Ltd. — McAllen Cold Storage, Ltd. Recalls Siluriformes Fish Products Produced Without Benefit Of Inspection
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·19V122000·2019-02-26

    International LT and Prostar Trucks Recalled for Exhaust Bracket Crack Risk

    Navistar is recalling 2016-2020 International LT and 2017-2018 Prostar trucks because a cracked exhaust bracket could cause the tailpipe to detach, creating a road hazard.

    Product
    INTERNATIONAL — INTERNATIONAL PROSTAR, LT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·022-2019·2019-02-26

    Sahlen Recalls Deli Ham Due to Possible Plastic Contamination

    Sahlen Packing Company is recalling approximately 13,224 pounds of ready-to-eat deli ham products that may contain plastic. The products were distributed to retail locations in six northeastern states.

    Product
    Sahlen Packing Company, Inc. — Sahlen Packing Company, Inc. Recalls Ready-To-Eat Deli Meat Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    6 states
  • SevereUSDA FSIS·021-2019·2019-02-25

    Crazy-Fresh Recalls Chicken Caesar Salad Due to Undeclared Allergens

    Russ Davis Wholesale is recalling chicken Caesar salad products because they contain undeclared milk and anchovies. No adverse reactions have been reported.

    Product
    Russ Davis Wholesale, Inc. — Russ Davis Wholesale - Crazy-Fresh Recalls Chicken Products due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state