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.

9776–9800 of 29157

  • SevereFDA (Drugs)·D-1104-2020·2020-04-15

    Avet Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity

    Avet Pharmaceuticals is recalling Losartan Potassium Tablets 100 mg because FDA labs found an impurity above acceptable levels.

    Product
    Losartan Potassium Tablets USP 100 mg, supplied in a) 30 count (NDC 23155-646-03, b) 90 count (NDC 23155-646-09) and 1000 count (NDC 23155-646-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India Manufactured for: Heritage Pharmaceutica
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1098-2020·2020-04-15

    Innovative Compounding Pharmacy Recalls Testosterone Cypionate Injectable Due to Sterility Concerns

    Innovative Compounding Pharmacy is recalling Testosterone Cypionate In Sesame Oil 200mg/ml injectable vials because the firm cannot assure the sterility of the product.

    Product
    Testosterone Cypionate In Sesame Oil 200mg/ml, 5 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1093-2020·2020-04-15

    PharMEDium Recalls Fentanyl Citrate Injection Due to Sterility Assurance Issues

    PharMEDium Services, LLC is recalling 46 lots of fentanyl citrate injection products because of a lack of sterility assurance.

    Product
    fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe, For IV Use, Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 05810. NDC 61553-303-28
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1131-2020·2020-04-15

    FDA Recalls Hernia Off for Unapproved New Drug Status

    Herbal Doctor Remedies is recalling Hernia Off because the product is misbranded as an unapproved new drug.

    Product
    Hernia Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1678-2020·2020-04-15

    Siemens Medical Solutions Recalls MEVATRON Radiation Therapy Systems

    Siemens Medical Solutions is recalling specific MEVATRON radiation therapy systems due to a potential safety issue with dose monitoring interlocks that could result in a 10-20% radiation overdose.

    Product
    MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2 #08515520, MEVATRON KD2 #01940753, MEVATRON M-2 6740 #09401506, MEVATRON MD-2 #09401654, MEVATRON MDX-2 #09401746 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
    Category
    Medical Device
    Distribution
    35 states
  • SevereFDA (Devices)·Z-1677-2020·2020-04-15

    Siemens ARTISTE MV System Recalled for Radiation Dose Monitoring Safety Interlock Defect

    Siemens is recalling ARTISTE MV Systems due to a potential safety issue with dose monitoring interlocks that could result in a 10-20% radiation therapy overdose.

    Product
    ARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
    Category
    Medical Device
    Distribution
    35 states
  • SevereFDA (Drugs)·D-1103-2020·2020-04-15

    Avet Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity

    Avet Pharmaceuticals is recalling Losartan Potassium Tablets 50 mg because FDA testing found an impurity above acceptable levels.

    Product
    Losartan Potassium Tablets USP 50 mg, a) 30 count (NDC 23155-645-03), b) 90 count (NDC 23155-645-09) and c) 1000 count (NDC 23155-645-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India, Manufactured for: Heritage Pharmaceutical Inc., E
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1680-2020·2020-04-15

    Siemens PRIMUS HI Linear Accelerators Recalled for Radiation Overdose Risk

    Siemens is recalling PRIMUS HI linear accelerators because a safety interlock defect could cause a 10-20% overdose of radiation therapy.

    Product
    PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
    Category
    Medical Device
    Distribution
    35 states
  • SevereFDA (Drugs)·D-1097-2020·2020-04-15

    Innovative Compounding Pharmacy Recalls Hydroxyprogesterone Caproate Due to Sterility Concerns

    Innovative Compounding Pharmacy is recalling Hydroxyprogesterone Caproate injections because the FDA cannot ensure the product is sterile. Patients in California, Maine, and Texas should stop using the medication.

    Product
    Hydroxyprogesterone Caproate (BUD) 350mg/ml , 4 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530
    Category
    Drug
    Distribution
    3 states
  • SevereNHTSA·20E022000·2020-04-13

    Takata Driver Air Bag Inflator Recall for Honda and Nissan Vehicles

    Honda and Nissan are recalling vehicles with Takata driver air bag inflators that may explode during deployment, posing a risk of serious injury or death.

    Product
    AIR BAGS:FRONTAL:DRIVER SIDE:INFLATOR MODULE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·008·2020-04-10

    Jowett Farms Recalls Pork Sausage Products Lacking Import Inspection

    Jowett Farms is recalling approximately 42,587 pounds of raw pork trimmings and processed sausage products that were not presented for import re-inspection into the United States.

    Product
    Jowett Farms Corporation Recalls Pork Products Produced without Benefit of Import Inspection
    Category
    Food
    Distribution
    2 states
  • SevereUSDA FSIS·007-2020·2020-04-10

    Conagra Recalls Frozen Chicken Bowls Due to Possible Rock Contamination

    Conagra Brands is recalling approximately 130,763 pounds of frozen Healthy Choice Chicken Feta & Farro bowls because they may contain small rocks.

    Product
    Conagra Brands (Conagra Foods Packaged Foods, LLC) — Conagra Brands, Inc. Recalls Frozen Not-Ready-to-Eat Chicken Bowl Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V207000·2020-04-09

    RAM 2500 and 3500 Trucks Recalled for Bed Step Failure Risk

    Chrysler is recalling 2019-2020 RAM 2500 and 3500 trucks because the accessory bed step may fail during use, increasing injury risk.

    Product
    RAM — RAM 3500, 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V209000·2020-04-09

    Forest River Recalls 2021 Starcraft Bus All Star Over Wiring Chafing

    Forest River is recalling 2021 Starcraft Bus All Star transit buses because a wire harness may chafe against the frame, potentially causing engine stalls or loss of braking stability.

    Product
    STARCRAFT BUS — STARCRAFT BUS ALL STAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V213000·2020-04-09

    Hyundai Recalls 2020 Nexo and Sonata for Parking Software Defect

    Hyundai is recalling 2020 Nexo and Sonata vehicles because a software defect in the Remote Smart Parking Assist system may allow unintended vehicle movement, increasing crash risk.

    Product
    HYUNDAI — HYUNDAI NEXO, SONATA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V210000·2020-04-09

    StarCraft Starquest School Bus Recall for Wire Harness Chaffing

    Forest River is recalling 2022 StarCraft Starquest school buses because a wire harness may chafe against the frame, potentially causing engine stalls or loss of braking stability.

    Product
    STARCRAFT BUS — STARCRAFT BUS STARQUEST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V202000·2020-04-08

    Great Dane Recalls 2020-2021 Everest Vans Due to Axle Nut Clip Defect

    Great Dane is recalling 2020-2021 Everest Refrigerated Vans because improperly installed axle nut retaining clips may cause loose wheels and loss of vehicle control.

    Product
    GREAT DANE — GREAT DANE EVEREST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1074-2020·2020-04-08

    Medical Center Pharmacy Recalls Vancomycin Opthal Drops Due to Sterility Concerns

    Medical Center Pharmacy is recalling Vancomycin Opthal 14 mg drops because production processes could not assure sterility. The product was distributed to patients in Tennessee.

    Product
    C-*Vancomycin Opthal 14 mg drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 67457-0340-01.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1077-2020·2020-04-08

    Medical Center Pharmacy Recalls Mitomycin Eye Drops Due to Sterility Concerns

    Medical Center Pharmacy is recalling two bottles of Mitomycin 0.04% Ophth DR eye drops because production processes could not assure sterility.

    Product
    *Mitomycin 0.04% Ophth DR eye drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 67457-0518-05.
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·20V206000·2020-04-08

    Vac-Tron Vacuum Excavator Trailers Recalled for Rear Impact Protection Defect

    Vac-Tron is recalling 2012-2020 vacuum excavator trailers because they may lack extended lower chassis, reducing rear impact protection and increasing crash risk.

    Product
    VAC-TRON — VAC-TRON MINICOMBO, MC 873 SDT, MC 835 SDT, MC 833 SDT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1632-2020·2020-04-08

    Merits E604 Pilot Navigator Stairlift Recalled Due to Pinion Gear Defect

    Merits Health Products is recalling 82 E604 Pilot Navigator Stairlifts because the pinion gear may disengage from the track, allowing the lift to slip or jolt.

    Product
    Merits E604 Pilot Navigator Stairlift - Product Usage: To transport patients up stairs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1073-2020·2020-04-08

    Medical Center Pharmacy Recalls C-Albumin Eye Drops Due to Sterility Concerns

    Medical Center Pharmacy is recalling specific lots of C-Albumin Eye Drop 10% S because production processes cannot assure sterility. Patients in Tennessee who received these prescriptions should contact their healthcare provider.

    Product
    C-*Albumin Eye Drop 10% S, packaged in 10 mL bottles, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 44206-0251-05.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1071-2020·2020-04-08

    Par Pharmaceutical Recalls Glycopyrrolate Tablets Due to Unknown Impurity

    Par Pharmaceutical is recalling 29,352 bottles of Glycopyrrolate Tablets, USP 1 mg, because an unknown impurity was detected.

    Product
    Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.S.A, Mfg. by: Par Formulations Private Limited, 1/58, Pudupakkam, Kelambakkam - 603 103., Made in India NDC# 49884-0065-01
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1072-2020·2020-04-08

    Gentamicin Irrigation Recalled for Lack of Sterility Assurance

    The Medicine Shoppe Pharmacy is recalling Gentamicin 80mg/60 mL Irrigation containers due to a lack of assurance of sterility.

    Product
    Gentamicin 80mg/60 mL Irrigation, containers, The Medicine Shoppe, 3524 B Tamiami Trail Port Charlotte, FL 33952
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1075-2020·2020-04-08

    Morphine 2 mg/mL CADD Cassettes Recalled for Sterility Concerns

    Medical Center Pharmacy is recalling Morphine 2 mg/mL CADD Cassettes because production processes cannot assure sterility. Patients in Tennessee who received specific prescriptions should contact their healthcare provider.

    Product
    *Morphine 2 mg/mL Cassette, 100 mL CADD Cassette, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 00409-1134-03.
    Category
    Drug
    Distribution
    1 state