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.

7876–7900 of 29121

  • SevereFDA (Drugs)·D-0739-2021·2021-08-25

    Teva Norepinephrine Bitartrate Injection Recalled for Sterility Assurance

    Teva Pharmaceuticals USA is recalling Norepinephrine Bitartrate Injection, USP 4 mg/4 mL vials due to lack of assurance of sterility. The product was distributed nationwide.

    Product
    Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials, packaged in 10 vial cartons (NDC 0703-1153-03) Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, vial NDC 0703-1153-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0923-2021·2021-08-25

    Lebenswert Folgemilch Stage 3 Organic Toddler Formula Recalled

    Able Groupe Inc is recalling Lebenswert Folgemilch Stage 3 Organic Toddler Formula because required FDA pre-market notifications were not submitted and the product lacks mandatory labeling in English as required by federal regulations.

    Product
    Lebenswert Folgemilch Stage 3 Organic Toddler Formula
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0730-2021·2021-08-25

    DAUNOrubicin Hydrochloride Injection Recalled Due to Sterility Assurance

    Teva Pharmaceuticals USA is recalling DAUNOrubicin Hydrochloride Injection 20 mg/4mL due to lack of assurance of sterility. The recall affects 1,351 vials distributed nationwide, including Puerto Rico.

    Product
    DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in 1 carton, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618 Vial NDC# 0703-5233-11, Carton NDC # 0703-5233-13
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0925-2021·2021-08-25

    HiPP UK Stage 2 Infant Formula Recalled for Missing FDA Notifications and Improper Labeling

    Able Groupe Inc is recalling HiPP UK Stage 2 Combiotic Follow-On Infant Milk Formula because required pre-market FDA notifications were not submitted and products lack mandatory English-language labeling as required by federal regulations.

    Product
    HiPP UK Stage 2 Combiotic Follow-On Infant Milk Formula
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0746-2021·2021-08-25

    Leucovorin Calcium for Injection Recalled Due to Sterility Assurance Concerns

    Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection in 100 mg/vial 10 mL single-use vials due to lack of assurance of sterility. The recall affects approximately 476,275 vials distributed nationwide, including Puerto Rico.

    Product
    Leucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5140-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0926-2021·2021-08-25

    Kendamil Organic Stage 1 Infant Formula Recalled for Missing FDA Notifications

    Able Groupe Inc is recalling Kendamil Organic Stage 1 First Infant Milk Formula because required pre-market FDA notifications were not submitted and the product lacks mandatory English labeling statements.

    Product
    Kendamil Organic Stage 1 First Infant Milk Formula
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0731-2021·2021-08-25

    Methylprednisolone Acetate Injectable Suspension Recall: Sterility Assurance

    Teva Pharmaceuticals USA is recalling Methylprednisolone Acetate Injectable Suspension USP 40 mg/mL in single-dose and multi-dose vials nationwide due to lack of assurance of sterility.

    Product
    Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0031-01), and b) 5mL Multi Dose Vials (NDC 0703-0043-01), and c) 10 mL Multi-Dose Vials (NDC 0703-0045-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0921-2021·2021-08-25

    Lebenswert Anfangsmilch Stage 1 Infant Formula Recall for Inadequate Iron and Labeling

    Able Groupe Inc is recalling Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula because some products contain insufficient iron and lack required FDA labeling. The formula may not provide adequate iron for certain infants, including premature infants and those with low birth weight.

    Product
    Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula
    Category
    Food
    Distribution
    0 states
  • SevereNHTSA·21V660000·2021-08-25

    Thomas Built Buses Saf-T-Liner HDX Recalled for Power Steering Hose Fire Risk

    Daimler Trucks North America is recalling 2016-2021 Thomas Built Buses Saf-T-Liner HDX transit buses because the power steering hose may be routed with inadequate clearance, potentially causing damage and increasing fire risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0907-2021·2021-08-25

    HiPP Comfort Milk Formula Recalled for Inadequate Iron and Labeling Violations

    Able Groupe Inc is recalling HiPP Comfort Milk Formula because some products contain insufficient iron and lack required labeling. The formula may not provide adequate iron for certain infants, particularly premature or low-birth-weight infants.

    Product
    HiPP Comfort Milk Formula
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0744-2021·2021-08-25

    Teva Octreotide Acetate Injection Recall: Sterility Assurance Loss

    Teva Pharmaceuticals is recalling Octreotide Acetate Injection 100 mcg/mL (Lot #31327466B, expiring 08/2021) nationwide due to lack of assurance of sterility. The affected product was distributed nationwide, including Puerto Rico.

    Product
    Octreotide Acetate Injection 100 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3311-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V659000·2021-08-25

    Thomas Built Buses Recalls Saf-T-Liner HDX School Buses for Fire Risk

    Daimler Trucks North America is recalling 2016-2021 Thomas Built Buses Saf-T-Liner HDX school buses because a power steering hose may be routed with inadequate clearance, increasing the risk of a fire.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0753-2021·2021-08-25

    Carvedilol Tablets Recalled for Foreign Paroxetine Tablets

    Zydus Pharmaceuticals is recalling Carvedilol 25 mg tablets nationwide after Paroxetine tablets were found mixed into bottles. Patients should not take affected bottles and contact their pharmacy or doctor.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0911-2021·2021-08-25

    HiPP Dutch Stage 2 Infant Formula Missing Pre-Market Approval and Labeling

    Able Groupe Inc is recalling HiPP Dutch Stage 2 Combiotic Follow-on Milk Formula because required pre-market notifications were not submitted to the FDA and products lack mandatory English labeling statements.

    Product
    HiPP Dutch Stage 2 Combiotic Follow-on Milk Formula
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0873-2021·2021-08-25

    Bacon Ranch Seasoning Recalled for Salmonella Contamination

    Mane Inc is recalling Flavored Bacon Ranch Seasoning packaged in 25lb kraft paper bags due to Salmonella detected in an ingredient used during manufacturing. The affected product was distributed to manufacturers in Ohio, Indiana, Minnesota, and Oregon.

    Product
    Flavored Bacon Ranch Seasoning Packaged in 25lb kraft paper bags
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0743-2021·2021-08-25

    Methylprednisolone Acetate Injectable Suspension recalled for sterility concerns

    Teva Pharmaceuticals is recalling Methylprednisolone Acetate Injectable Suspension USP 80 mg/mL due to lack of assurance of sterility. The recall affects single-dose and multi-dose vials distributed nationwide, including Puerto Rico.

    Product
    Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0051-01), and b) 5mL Multi Dose Vials (NDC 0703-0063-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0741-2021·2021-08-25

    Metoclopramide Injection Vials Recalled for Lack of Sterility Assurance

    Teva Pharmaceuticals USA is recalling 25,653 vials of Metoclopramide Injection USP due to lack of assurance of sterility. The affected vials were distributed nationwide, including Puerto Rico.

    Product
    METOCLOPRAMIDE — METOCLOPRAMIDE (METOCLOPRAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0747-2021·2021-08-25

    Leucovorin Calcium for Injection recalled for lack of sterility assurance

    Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection (350 mg/vial) distributed nationwide because the manufacturer cannot assure the product is sterile. Patients using recalled lot should consult their healthcare provider.

    Product
    Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Manufactured by: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-5145-91
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0918-2021·2021-08-25

    Holle Bio Stage 2 Organic Infant Formula Lacks Required FDA Pre-Market Notification

    Able Groupe Inc is recalling Holle Bio Stage 2 Organic Follow-On Infant Milk Formula because required FDA pre-market notifications were not submitted and the product lacks mandatory labeling in English required by federal regulations.

    Product
    Holle Bio Stage 2 Organic Follow-On Infant Milk Formula
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0732-2021·2021-08-25

    Haloperidol Decanoate Injection recalled due to sterility concerns

    Teva Pharmaceuticals USA is recalling Haloperidol Decanoate Injection 100 mg/mL due to lack of assurance of sterility. The recall affects 16,226 vials distributed nationwide, including Puerto Rico.

    Product
    Haloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vials (NDC 0703-7131-01), b) 5 mL multi-dose vials (NDC 0703-7133-01), Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·21E079000·2021-08-25

    Rigid Hitch Recalls Specific Tow Hitches Due to Weld Defects

    Rigid Hitch is recalling certain DHB-series tow hitches because incorrect welding settings may cause the weld to fail, increasing the risk of a crash.

    Product
    STRUCTURE:BODY:TAILGATE:HINGE AND ATTACHMENTS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V658000·2021-08-25

    Summit Trailer Recalls One 2017 AD45 for Steering Arm Defect

    Summit Trailer Sales is recalling one 2017 AD45 trailer because the steering arm may detach, potentially causing loss of steering control or a road hazard.

    Product
    SUMMIT — SUMMIT AD45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21E080000·2021-08-25

    Joyson Recalls Curtain Air Bag Inflators Due to Rupture Risk

    Key Safety Systems (DBA Joyson) is recalling specific HPH-A curtain air bag inflators because moisture-induced corrosion can cause the inflator to rupture, potentially sending fragments into the vehicle cabin.

    Product
    AIR BAGS:SIDE/WINDOW:CURTAIN:INFLATOR recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21E081000·2021-08-25

    Deking LP Regulators Recalled Due to Fire Risk from Excessive Pressure

    Deking Corporation is recalling Winntec and WIC Model 6020 LP regulators installed in recreational vehicles. The parts may fail and cause excessive gas pressure, increasing the risk of fire.

    Product
    EQUIPMENT:RECREATIONAL VEHICLE/TRAILER:LPG SYSTEMS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide