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.

4626–4650 of 4878

  • SevereFDA (Drugs)·D-0745-2021·2021-08-25

    Octreotide Acetate Injection 50 mcg/mL Recalled for Lack of Sterility Assurance

    Teva Pharmaceuticals is recalling Octreotide Acetate Injection 50 mcg/mL in single-dose vials due to lack of assurance of sterility. The recall affects specific lots distributed nationwide, including Puerto Rico.

    Product
    Octreotide Acetate Injection 50 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3301-01
    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 (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
  • 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 (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 (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 (Food)·F-0872-2021·2021-08-25

    Ballreich Barbeque Marcelled Potato Chips Salmonella Contamination Recall

    Ballreich Snack Food Company is recalling Barbeque Marcelled Potato Chips in 1.5, 2.5, and 7 ounce packages due to possible Salmonella contamination from an ingredient. The affected products were distributed in Indiana, Michigan, and Ohio.

    Product
    Barbeque Marcelled Potato Chips Ballreich Snack Food Company 1.5, 2.5, and 7 ounce flexible plastic packaging 1.5 ounce/72 case, 2.75 ounce 32/case, 7 ounce 14/case
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0910-2021·2021-08-25

    HiPP HA Infant Formula Recalled for Inadequate Iron and Missing Labeling

    Able Groupe Inc is recalling HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk Formula (76,000 units) because some products contain less than the required iron per serving and lack mandatory FDA-compliant English labeling.

    Product
    HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk Formula
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0733-2021·2021-08-25

    Amikacin Sulfate Injection Recalled Due to Sterility Assurance Failure

    Teva Pharmaceuticals USA is recalling Amikacin Sulfate Injection USP 1 gram/4mL vials nationwide due to lack of assurance of sterility. The recall affects 4,712 vials with lot #31329243B and expiration date 05/2022.

    Product
    Amikacin Sulfate Injection USP 1 gram/4mL (250mg/ML), 4 mL single-dose vials, Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0703-9040-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0738-2021·2021-08-25

    Teva Epoprostenol Sodium for Injection Recalled for Sterility Assurance

    Teva Pharmaceuticals USA is recalling Epoprostenol Sodium for Injection (1.5 mg/vial, 10 mL vials) due to lack of assurance of sterility. The affected lot was distributed nationwide.

    Product
    Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-1995-01
    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-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 (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-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 (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 (Food)·F-0914-2021·2021-08-25

    HiPP German Stage 1 Infant Formula Lacks FDA Pre-Market Notification

    Able Groupe Inc is recalling HiPP German Stage 1 Combiotic Infant Milk Formula because required FDA pre-market notifications were not submitted. Some units contain inadequate iron levels and lack required English labeling.

    Product
    HiPP German Stage 1 Combiotic Infant Milk Formula
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0909-2021·2021-08-25

    HiPP Dutch Stage 1 Infant Formula Recalled for Inadequate Iron Content

    Able Groupe Inc is recalling HiPP Dutch Stage 1 Combiotic Infant Milk Formula because it was not approved by the FDA and may contain insufficient iron for vulnerable infants, particularly those born prematurely or with low birth weight.

    Product
    HiPP Dutch Stage 1 Combiotic Infant Milk Formula
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0748-2021·2021-08-25

    Adenosine Injection Recalled for Lack of Sterility Assurance

    Teva Pharmaceuticals USA is recalling Adenosine Injection (60 mg/20 mL vials) nationwide due to lack of assurance of sterility, which could pose a serious health risk if the product is not sterile.

    Product
    Adenosine Injection, USP, 60mg/20 mL (3 mg/mL), 20 mL single-dose vial, Rx only, Mfd in the USA for: NorthStar Rx LLC Memphis, TN 38141, NDC 16714-180-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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 (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
  • SevereFDA (Drugs)·D-0736-2021·2021-08-25

    Teva Octreotide Acetate Injection Recalled for Sterility Assurance Failure

    Teva Pharmaceuticals is recalling Octreotide Acetate Injection 1000 mcg/5mL vials nationwide due to lack of assurance of sterility. The recall affects 16,644 vials distributed nationally.

    Product
    Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3333-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-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
  • SevereFDA (Food)·F-0922-2021·2021-08-25

    Lebenswert Stage 2 Infant Formula Recalled for Missing Labeling

    Able Groupe Inc is recalling Lebenswert Folgemilch Stage 2 Organic Follow-On Infant Milk Formula (76,000 units) sold directly through littlebundle.com. The formula was not submitted for required FDA pre-market notification and lacks mandatory English-language labeling.

    Product
    Lebenswert Folgemilch Stage 2 Organic Follow-On Infant Milk Formula
    Category
    Food
    Distribution
    0 states