The Recall Desk

Hazard

Sterility recalls

2,384 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,384
Critical
1
Severe
2,114
Most recent
2026-09-09

Of the 2,384 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 2,114 (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.

2251–2275 of 2384

  • SevereFDA (Drugs)·D-613-2013·2013-07-03

    Hospira Recalls Sodium Chloride Injection Due to Sterility Concerns

    Hospira is voluntarily recalling 0.45% Sodium Chloride Injection due to possible leaking bags that may compromise sterility.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-614-2013·2013-07-03

    Hospira Recalls 5% Dextrose Injection Due to Sterility Concerns

    Hospira is voluntarily recalling 5% Dextrose Injection USP bags due to possible leaking that compromises sterility assurance.

    Product
    5% Dextrose Injection USP, a) 250 mL (NDC 0409-7922-02), b) 500 mL (NDC 0409-7922-30), by Hospira, Inc., Lake Forest, IL 60045
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-611-2013·2013-07-03

    Hospira Recalls 0.9% Sodium Chloride Injection Due to Sterility Concerns

    Hospira is voluntarily recalling 0.9% Sodium Chloride Injection in flexible containers due to possible leaking bags that may compromise sterility.

    Product
    0.9% Sodium Chloride Injection, USP, Polyolefin Flexible Container, a) 500 mL (NDC 0409-7983-30), b) 1000 mL (NDC 0409-7983-48), c) 250 mL (NDC 0409-7983-02), d) 150 mL (NDC 0409-7983-61), Rx Only, by Hospira, Inc., Lake Forest, IL 60045
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-619-2013·2013-07-03

    Hospira Recalls Sodium Chloride Injection Due to Sterility Concerns

    Hospira is voluntarily recalling specific lots of 0.9% Sodium Chloride Injection due to possible leaking bags that may compromise sterility.

    Product
    0.9% Sodium Chloride Injection, USP, a) 50 mL (NDC 0409-7984-13), b) 50 mL (NDC 0409-7984-36), c) 100 mL (0409-7984-37), Rx Only, Hospira, Inc., Lake Forest, IL 60045
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-608-2013·2013-06-26

    Hospira Recalls 0.9% Sodium Chloride Injection Due to Sterility Concerns

    Hospira is recalling 676,872 containers of 0.9% Sodium Chloride Injection due to a potential leak at the administrative port that compromises sterility.

    Product
    0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-597-2013·2013-06-19

    Sandoz Recalls Cefazolin Injection Vials Due to Sterility Concerns

    Sandoz Inc. is recalling Cefazolin for Injection, USP 1 gm vials, lot DB2208, due to a lack of assurance of sterility caused by broken or cracked vials.

    Product
    Cefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, single-use vial, Manufactured in Austria by Sandoz GmbH for Sandoz, Inc. Princeton, NJ 08540, NDC 00781-3451-70 (vial), NDC 00781-3451-96 (box)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-589-2013·2013-06-12

    Pentec Health Recalls Proplete 70+ KG Due to Sterility Concerns

    Pentec Health is recalling 38 bags of Proplete 70+ KG renal nutritional solution because sterility could not be assured for the compounded product.

    Product
    Proplete 70+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 635mL bag and b) 660mL bag, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-588-2013·2013-06-12

    Pentec Health Recalls Proplete 60-69 KG Intradialytic Nutrition Bags

    Pentec Health is recalling 59 bags of Proplete 60-69 KG intradialytic parenteral nutrition due to a lack of assurance of sterility.

    Product
    Proplete 60 - 69 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in 555mL bag, Pentec Health Inc, 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-502-2013·2013-06-12

    Hospira Recalls Dobutamine in Dextrose Injection Due to Sterility Concerns

    Hospira Inc. is recalling 44,748 bags of Dobutamine in Dextrose Injection because a confirmed leak in the primary container raises concerns about sterility.

    Product
    DOBUTAMINE IN DEXTROSE — DOBUTAMINE IN DEXTROSE (DOBUTAMINE IN DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-583-2013·2013-06-12

    Pentec Health Recalls Baxter LL Bag Amino Acids Due to Sterility Concerns

    Pentec Health is recalling Baxter LL bag 1% Amino Acids because sterility could not be assured for the compounded sterile renal nutritional prescriptions.

    Product
    Baxter LL bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 3000mL bag, b) 5000mL bag and c) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-567-2013·2013-06-12

    Testosterone Cypionate Injectable Recalled Due to Sterility Concerns

    The Compounding Shop is recalling Testosterone Cypionate 200 mg/mL injectable vials due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Testosterone Cypionate 200 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-554-2013·2013-06-12

    Dexpanthenol Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Shop is recalling Dexpanthenol 200 mg/mL Injectable vials because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    Dexpanthenol 200 mg/mL Injectable, 100 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-501-2013·2013-06-12

    Hospira Recalls Diazepam Injection Vials Due to Sterility Concerns

    Hospira Inc. is recalling 95,700 vials of Diazepam Injection due to a loose crimp on the fliptop vial, which compromises sterility assurance.

    Product
    DIAZEPAM — DIAZEPAM (DIAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-584-2013·2013-06-12

    Pentec Health Recalls Fresenius Amino Acid Bags Due to Sterility Concerns

    Pentec Health is recalling Fresenius 1% Amino Acid bags because sterility could not be assured for compounded renal nutritional prescriptions.

    Product
    Fresenius bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), 1000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-569-2013·2013-06-12

    Carnosine 5% Eye Drops Recalled for Sterility Concerns

    The Compounding Shop is recalling Carnosine 5% Opth drops due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Carnosine 5% Opth drop, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-548-2013·2013-06-12

    Methotrexate Injectable Recalled Due to Sterility Concerns

    The Compounding Shop is recalling Methotrexate 25mg/mL Injectable vials due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Methotrexate 25mg/mL Injectable, 10 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-564-2013·2013-06-12

    B-Complex Injectable Recalled Due to Sterility Concerns

    The Compounding Shop is recalling B-Complex 100 mg/mL Injectable vials due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    B-Complex 100 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-559-2013·2013-06-12

    Lipoic Acid Injectable Recalled for Sterility Concerns

    The Compounding Shop is recalling Lipoic Acid 25 mg/mL Injectable vials due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Lipoic Acid 25 mg/mL Injectable, 100 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-560-2013·2013-06-12

    Mitomycin Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Shop is recalling Mitomycin 0.3 mg/mL Injectable vials because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Mitomycin 0.3 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-552-2013·2013-06-12

    Baclofen/Bupivacaine Injectable Recalled Due to Sterility Concerns

    The Compounding Shop is recalling Baclofen/Bupivacaine injectable vials because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-591-2013·2013-06-12

    Pentec Health Recalls Proplete 90+ KG Due to Sterility Concerns

    Pentec Health is recalling Proplete 90+ KG dialysate solution because sterility could not be assured. The product was distributed to dialysis centers and directly to patients.

    Product
    Proplete 90+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 805mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-572-2013·2013-06-12

    Tri-Mix Injections Recalled Due to Sterility Assurance Concerns

    The Compounding Shop is recalling Tri-Mix Injections because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Tri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Papaverine), compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-556-2013·2013-06-12

    FDA Recalls Hydroxyprogesterone Injectable Due to Sterility Concerns

    The Compounding Shop is recalling Hydroxyprogesterone 250 mg/mL injectable vials because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    Hydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-555-2013·2013-06-12

    Dexamethasone Injectable Recalled for Sterility Concerns

    The Compounding Shop is recalling Dexamethasone 10 mg/mL Injectable vials due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Dexamethasone 10 mg/mL Injectable, 2 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-568-2013·2013-06-12

    Morphine Sulfate Injectable Recalled Due to Sterility Concerns

    The Compounding Shop is recalling Morphine Sulfate 25 mg/mL Injectable vials due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Morphine Sulfate 25 mg/mL Injectable, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states