The Recall Desk

Hazard

Sterility recalls

2,383 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,383
Critical
1
Severe
2,113
Most recent
2026-08-26

Of the 2,383 sterility recalls we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,113 (89%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterility recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

701–725 of 2383

  • SevereFDA (Drugs)·D-0898-2018·2018-07-11

    SCA Pharmaceuticals Recalls Norepinephrine Bags Due to Sterility Concerns

    SCA Pharmaceuticals is voluntarily recalling specific lots of Norepinephrine Bitartrate bags due to a potential for leakage that compromises sterility.

    Product
    Norepinephrine Bitartrate 4 mg (16 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0895-2018·2018-07-11

    SCA Pharmaceuticals Recalls Fentanyl Bags Due to Sterility Concerns

    SCA Pharmaceuticals is voluntarily recalling 492 bags of Fentanyl admixture due to a potential for leakage that compromises sterility.

    Product
    Fentanyl (as citrate) 10 mcg/mL in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-0899-2018·2018-07-11

    SCA Pharmaceuticals Recalls Norepinephrine Bitartrate Bags Due to Sterility Concerns

    SCA Pharmaceuticals is voluntarily recalling specific lots of Norepinephrine Bitartrate 8 mg bags due to a potential for leakage that compromises sterility.

    Product
    Norepinephrine Bitartrate 8 mg (32 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0882-2018·2018-06-27

    ICU Medical Recalls Sodium Chloride Injection Bags Due to Sterility Concerns

    ICU Medical is recalling 941,496 bags of 0.9% Sodium Chloride Injection due to a lack of assurance of sterility and potential for leaking.

    Product
    0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7983-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0883-2018·2018-06-27

    ICU Medical Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns

    ICU Medical is recalling 525,984 bags of 0.9% Sodium Chloride Injection due to potential leaks that compromise sterility. The product was distributed nationwide and in Canada.

    Product
    0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-23
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0881-2018·2018-06-27

    ICU Medical Recalls 0.45% Sodium Chloride Injection Bags Due to Sterility Concerns

    ICU Medical Inc. is recalling 88,960 bags of 0.45% Sodium Chloride Injection due to a lack of assurance of sterility and potential for leaking.

    Product
    0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7730-37
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0884-2018·2018-06-27

    ICU Medical Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns

    ICU Medical Inc is recalling 0.9% Sodium Chloride Injection bags because they may leak, compromising sterility. The recall covers lots distributed nationwide and in Canada.

    Product
    0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only ,Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-37
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0827-2018·2018-05-30

    Fresenius Recalls 0.9% Sodium Chloride Injection Due to Sterility Concerns

    Fresenius Medical Care is recalling 25,356 bags of 0.9% Sodium Chloride Injection due to a lack of assurance of sterility.

    Product
    0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0730-2018·2018-05-16

    Vitalab Pharmacy Recalls Sterile Injectable Drug Due to Sterility Concerns

    Vitalab Pharmacy is recalling 22 vials of a sterile injectable drug because airflow patterns may not support aseptic production, raising sterility concerns.

    Product
    Papaverine 9mg/Phentolamine 1mg/Atropine 0.1mg/Prostaglandinl 10mcg/ml, sterile injectable, Vitalab Pharmacy, Inc
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0732-2018·2018-05-16

    Vitalab Pharmacy Recalls Sterile Injectable Drugs Due to Sterility Concerns

    Vitalab Pharmacy is recalling specific lots of sterile injectable drugs because airflow patterns may not support aseptic production, raising sterility concerns.

    Product
    Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable, ST3:Papaverine 40mg/Phentolamine 3mg/Prostaglandin 60mcg/mL, Vitalab Pharmacy, Inc.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0729-2018·2018-05-16

    Vitalab Alprostadil Injectable Recalled for Sterility Assurance Concerns

    Vitalab Pharmacy is recalling Alprostadil 20 mcg/mL injectable vials because airflow patterns may not support aseptic production, raising sterility concerns.

    Product
    Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0728-2018·2018-05-16

    Vitalab Methylcobalamin Injection Recalled Due to Sterility Concerns

    Vitalab Pharmacy is recalling 178 vials of Methylcobalamin for injection because airflow patterns may not support aseptic production, raising sterility concerns.

    Product
    Methylcobalamin for injection, 1mg/mL and 10 mg/mL, Sterile injectable, Vitalab Pharmacy, Inc
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-0733-2018·2018-05-16

    Vitalab Pharmacy Recalls Sterile Injectable Drugs Due to Sterility Concerns

    Vitalab Pharmacy is recalling specific lots of sterile injectable drugs because airflow patterns may not support aseptic production.

    Product
    Papaverine 30mg/Phentolamine 2mg/Prostaglandin 20mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 10mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 25mcg/mL, sterile injectables, Vitalab Pharmacy, Inc
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-1776-2018·2018-05-16

    Transonic ADT1018 Hemodialysis Tubing Recalled Due to Sterility Concerns

    Transonic Systems Inc. is recalling ADT1018 Flow QC Clear Advantage Tubing because the sterility of the device cannot be assured, posing a potential risk of infection.

    Product
    Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for use as part of an extracorporeal blood circuit for hemodialysis when a monitor will be used to make access flow, recirculation, and/or cardiac output measurements duri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0705-2018·2018-05-09

    AuroMedics Recalls Levetiracetam Injection Due to Sterility Concerns

    AuroMedics Pharma LLC is recalling 261,250 bags of Levetiracetam Injection due to a confirmed report of leaking bags and mold found between the outer bag and overwrap.

    Product
    LEVETIRACETAM — LEVETIRACETAM (LEVETIRACETAM IN SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0707-2018·2018-05-09

    AuroMedics Recalls Levetiracetam Injection Due to Sterility Concerns

    AuroMedics Pharma LLC is recalling 67,300 bags of Levetiracetam Injection due to a confirmed report of leaking bags and mold found between the outer bag and overwrap.

    Product
    LEVETIRACETAM — LEVETIRACETAM (LEVETIRACETAM IN SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0708-2018·2018-05-09

    AuroMedics Recalls Levofloxacin Injection Bags Due to Sterility Concerns

    AuroMedics Pharma LLC is recalling specific lots of Levofloxacin in 5% Dextrose Injection due to a lack of assurance of sterility and reports of leaking bags with mold.

    Product
    LEVOFLOXACIN — LEVOFLOXACIN (LEVOFLOXACIN IN 5% DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0706-2018·2018-05-09

    AuroMedics Recalls Levetiracetam Injection Due to Sterility Concerns

    AuroMedics Pharma LLC is recalling Levetiracetam Injection due to a lack of assurance of sterility and a confirmed report of leaking bags and mold.

    Product
    LEVETIRACETAM — LEVETIRACETAM (LEVETIRACETAM IN SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0655-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Methylcobalamin Injectable Liquid Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling Methylcobalamin 12.5 mg/mL Injectable Liquid in Nevada due to a non-approved method of sterilization.

    Product
    Methylcobalamin 12.5 mg/mL, Injectable Liquid, packaged in a) 5 mL amber vial, and b) 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0640-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Lipoic Acid Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling Lipoic Acid 25mg/mL vials in Nevada because the firm used a non-approved method of sterilization.

    Product
    Lipoic Acid 25mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0639-2018·2018-04-25

    Partell Specialty Pharmacy Recalls HCG Vials Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling HCG 1000 units/mL vials in Nevada because a non-approved sterilization method was used.

    Product
    HCG 1000 units/mL, packaged in a) 2 mL and b) 6 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0642-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Methionine Injection Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling Methionine 25mg/Inositol 50mg/Choline 50mg/B12 1mg injections because they were sterilized using a non-approved method.

    Product
    Methionine 25mg/Inositol 50mg/Choline 50mg/ B12 1mg, packaged in a) 5 mL amber vial and b) 50mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0672-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Testosterone and Anastrozole Pellets Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling Testosterone/Anastrozole pellets in Nevada because they were sterilized using a non-approved method.

    Product
    Testosterone/Anastrozole 60 mg/4 mg pellets packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0675-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Estradiol Pellets Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling Estradiol 15 mg pellets in Nevada due to a non-approved sterilization method.

    Product
    Estradiol 15 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0654-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling Testosterone/Finasteride/Anastrozole pellets because they were sterilized using a non-approved method.

    Product
    Testosterone/Finasteride/Anastrozole 120 mg/10 mg/4 mg pellet Amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
    Category
    Drug
    Distribution
    1 state