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.

4201–4225 of 4878

  • SevereCPSC·22045·2022-01-11

    Bella Residential Elevators Recalled for Child Entrapment Hazard

    Bella residential elevators pose a risk of child entrapment between exterior and interior doors. Young children can become trapped and suffer serious injuries or death when the elevator moves to another floor.

    Product
    Bella residential elevators
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V817000·2022-01-11

    Brake modulator corrosion recall on Freightliner and Western Star commercial trucks

    Daimler Trucks North America is recalling certain Freightliner Cascadia and Western Star models due to corrosion in front brake modulator valves. The defect may cause brakes to pull to one side during automated braking, increasing crash risk.

    Product
    FREIGHTLINER — 2017 FREIGHTLINER CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·22047·2022-01-11

    Residential Elevators Recalled for Child Entrapment Hazard

    Savaria and Garaventa residential elevators pose an entrapment risk to young children due to gaps between doors. Young children can become trapped and suffer serious injury or death when the elevator is called to another floor.

    Product
    Savaria and Garaventa branded residential elevators
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V663000·2022-01-09

    Jayco and Entegra motorhomes recalled for suspension torsion bar defect

    Entegra and Jayco motorhomes may have incorrectly installed torsion bar shims causing potential suspension failure. Dealers will replace the defective component free of charge.

    Product
    ENTEGRA — 2021 ENTEGRA QWEST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V662000·2022-01-09

    Honda CRF1100 Africa Twin Motorcycles Recalled for Engine Control Software Bug

    Honda is recalling 2020-2021 CRF1100 Africa Twin motorcycles due to an ECU software error that may cause engine stall or loss of drive power. Owners can get a free software update from dealers.

    Product
    HONDA — 2021 HONDA CRF1100 AFRICA TWIN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V558000·2022-01-08

    Forest River Rockwood and Flagstaff tent campers recalled for defective brake axle

    Forest River is recalling certain 2022 Flagstaff and 2022-2023 Rockwood tent campers due to improperly installed axles that can reduce brake function. Owners should contact their dealer for free inspection and repair.

    Product
    FOREST RIVER — 2022 FOREST RIVER ROCKWOOD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V529000·2022-01-07

    Entegra and Jayco recreational vehicles recalled for window adhesive failure

    Jayco is recalling certain 2019-2021 recreational vehicles with Hehr 6400 series windows due to adhesive failure. The window vent may detach, increasing the risk of crash or injury.

    Product
    ENTEGRA — 2020 ENTEGRA ANTHEM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0323-2022·2022-01-05

    SterRx Phenylephrine HCl Injection Recalled for Sterility Assurance

    SterRx is recalling PHENYLephrine HCl 40 mg per 250 mL injectable solution nationwide due to lack of assurance of sterility. The recall affects approximately 20,640 bags distributed across the United States.

    Product
    PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-252-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0318-2022·2022-01-05

    SterRx Morphine Sulfate Injection Recalled for Sterility Assurance

    SterRx is recalling 880 bags of Morphine Sulfate in 0.9% Sodium Chloride Injection nationwide due to lack of assurance of sterility. Patients and healthcare providers should stop using affected units immediately.

    Product
    MORPHINE SULFATE, in 0.9% Sodium Chloride Injection, 50 mg per 50 mL, (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-427-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0319-2022·2022-01-05

    SterRx Norepinephrine Injection Recalled for Lack of Sterility Assurance

    SterRx is recalling 1,044 bags of Norepinephrine 16 mg per 250 mL in 5% Dextrose Injection nationwide due to lack of assurance of sterility. The affected product carries NDC 70324-002-01 with lot code S21194/CDW.

    Product
    NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-002-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0299-2022·2022-01-05

    Veklury (Remdesivir) Drug Vials Recalled for Glass Particulate Matter

    Gilead Sciences is recalling Veklury (remdesivir) injection vials nationwide due to the presence of glass particulates detected during a customer complaint investigation. The affected lots are 2141001-1A and 2141002-1A with expiration date 01/2024.

    Product
    VEKLURY — VEKLURY (REMDESIVIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0309-2022·2022-01-05

    Epinephrine Injection Recalled for Lack of Sterility Assurance

    SterRx is recalling epinephrine in 0.9% sodium chloride injection (5 mg per 250 mL) nationwide due to lack of assurance of sterility. Affected lots are identified by codes S21255/BXA, S21264/BXH, and S21328/BZO.

    Product
    EPINEPHIrine in 0.9% Sodium Chloride Injection, 5 mg per 250 mL (20 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-052-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0316-2022·2022-01-05

    SterRx Fentanyl Citrate Injection Recalled for Sterility Assurance Failure

    SterRx is recalling fentanyl citrate injection nationwide due to lack of assurance of sterility. The recall affects approximately 10,660 bags of the product.

    Product
    Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 1 mg per 100 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-327-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0302-2022·2022-01-05

    dilTIAZem HCl Injection Recalled Due to Sterility Assurance Failure

    SterRx is recalling dilTIAZem HCl 125 mg per 125 mL injectable solution nationwide due to lack of assurance of sterility. The recall affects 24,300 bags distributed across the United States.

    Product
    dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-976-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0314-2022·2022-01-05

    SterRx Norepinephrine Injection Recalled for Lack of Sterility Assurance

    SterRx is recalling 1,428 bags of Norepinephrine in 5% Dextrose Injection nationwide due to lack of assurance of sterility. The product is a prescription injectable medication.

    Product
    NOREPINEPHRINE in 5% Dextrose Injection, 8 mg per 250 mL (32 mg per mL) Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-476-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0356-2022·2022-01-05

    Giant Eagle Diced Green Peppers Recalled for Listeria Contamination

    Frozen Food Development is recalling Giant Eagle brand diced green peppers in multiple package sizes due to positive testing for Listeria monocytogenes. The product was distributed to three accounts in the United States.

    Product
    Giant Eagle, Diced Green Peppers, 10 oz. poly bags and 22# cases, also poly bags and cartons, 12/10 oz. bags per case and bulk 22 lbs. bags
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0300-2022·2022-01-05

    SterRx Midazolam Injection Recalled for Lack of Sterility Assurance

    SterRx, LLC is recalling Midazolam in 0.9% Sodium Chloride Injection (50 mg per 50 mL) distributed nationwide due to lack of assurance of sterility. The recall affects 15,660 bags from seven lots manufactured between November and December 2021.

    Product
    Midazolam in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave. Plattsburgh, NY 12003, NDC #70324-102-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0311-2022·2022-01-05

    SterRx Epinephrine Injection Recalled for Lack of Sterility Assurance

    SterRx is recalling 684 bags of epinephrine in 0.9% sodium chloride injection nationwide due to lack of assurance of sterility. The product is supplied to hospitals and healthcare facilities.

    Product
    EPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-627-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0298-2022·2022-01-05

    Klean Touch Hand Sanitizer Recalled: Unapproved Methanol-Containing Drug

    Aroma Release Technologies Inc is recalling Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) in 55-gallon drums because the product contains methanol and was marketed without FDA approval as a new drug.

    Product
    Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) Ingredients Ethanol and Methanol, in 55-gallon drums, Aroma Release Technology, Inc., 7026 Discovery Drive, Chattanooga, TN 37416
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0306-2022·2022-01-05

    Sodium Bicarbonate in 5% Dextrose Injection Recalled for Sterility Assurance

    SterRx is recalling Sodium Bicarbonate in 5% Dextrose Injection nationwide due to lack of assurance of sterility. The recall affects 127,260 bags distributed across the U.S.

    Product
    Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1000 mL (12.6 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0310-2022·2022-01-05

    Epinephrine Injection Recalled for Lack of Sterility Assurance

    SterRx is recalling epinephrine injection (8 mg per 250 mL) due to lack of assurance of sterility. The recall affects 5,832 bags distributed nationwide.

    Product
    EPINEPHIrine in 0.9% Sodium Chloride Injection, 8 mg per 250 mL (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-077-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0305-2022·2022-01-05

    Phenylephrine HCL Injection Recalled for Lack of Sterility Assurance

    SterRx is recalling approximately 18,948 bags of Phenylephrine HCL in 0.9% Sodium Chloride injection nationwide due to lack of assurance of sterility. The product is distributed across the U.S.A.

    Product
    PHENYLepherine HCL in 0.9% Sodium Chloride, 20 mg per 250 mL (80 mcg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-701-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0308-2022·2022-01-05

    SterRx Epinephrine Injection Recalled for Lack of Sterility Assurance

    SterRx is recalling epinephrine in 0.9% sodium chloride injection (4 mg per 250 mL) nationwide due to lack of assurance of sterility. The recall affects 26,928 bags distributed across the United States.

    Product
    EPINEPHIrine in 0.9% Sodium Chloride Injection, 4 mg per 250 mL (16 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-227-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0325-2022·2022-01-05

    Sodium Bicarbonate in 5% Dextrose Injection Lacks Sterility Assurance

    SterRx is recalling 2,886 bags of Sodium Bicarbonate in 5% Dextrose Injection nationwide due to lack of assurance of sterility. The affected product may pose a risk to patients who receive this intravenous medication.

    Product
    Sodium Bicarbonate in 5% Dextrose Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0295-2022·2022-01-05

    Lidocaine Hydrochloride Topical Solution recalled for being superpotent

    Teligent Pharma has recalled 6,816 bottles of Lidocaine Hydrochloride Topical Solution 4% nationwide due to the drug being superpotent. The recall is voluntary and involves Lot #16345 with expiration date 01/2024.

    Product
    LIDOCAINE HYDROCHLORIDE — LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide