The Recall Desk

Hazard

Non Sterility recalls

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

What the numbers show

Total
145
Critical
85
Severe
55
Most recent
2026-07-01

Of the 145 non sterility recalls we have scored against our rubric, 85 (59%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 55 (38%) 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 non 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.

101–125 of 145

  • CriticalFDA (Drugs)·D-458-2015·2015-04-15

    CAPS Recalls Neonatal IV Infusion Bags Due to Sterility Test Failures

    Central Admixture Pharmacy Services is recalling 4 bags of compounded neonatal IV infusion bags because they failed sterility tests for microbial contamination.

    Product
    Robert Wood Johnson University (NJ) Neonatal Starter 10% Dextrose, Trophamine 5%, Dextrose 10%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown…
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-469-2015·2015-04-15

    FDA Recalls Two Bags of Neonatal TPN Due to Sterility Failure

    Central Admixture Pharmacy Services is recalling two bags of neonatal TPN bags due to out-of-specification sterility test results.

    Product
    Spotsylvania Regional Med Ctr (VA) TPN Neonatal Starter Bag, Trophamine 5 gm , Dextrose 10%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-461-2015·2015-04-15

    Central Admixture Pharmacy Services Recalls Non-Sterile Neonatal TPN Bags

    Central Admixture Pharmacy Services is recalling four bags of neonatal TPN due to sterility test failures. The product was distributed nationwide.

    Product
    Abington Memorial Hospital (PA) TPN Neonatal Starter 0.6-0.99 Kg, Amino Acids, Neonate 5g, Dextrose 7.5%, 250 ml, Additives: heparin PF 125 unit(s)/ml, Calcium Gluconate 500mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a…
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-448-2015·2015-04-15

    Central Admixture Pharmacy Services Recalls NICU TPN Starter Due to Sterility Failure

    Central Admixture Pharmacy Services is recalling a specific lot of NICU TPN Starter IV bags because sterility tests showed microbial contamination.

    Product
    Olathe Medical Center (KS) NICU TPN Starter: Ingredients per 80 ml, Trophamine 3g Dextrose 10%, Additives: Calcium Gluconate 250mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a…
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-443-2015·2015-04-15

    FDA Recalls Compounded Neonatal IV Infusion Bags Due to Sterility Failure

    Central Admixture Pharmacy Services is recalling two bags of compounded neonatal IV infusion bags because they failed sterility tests for microbial contamination.

    Product
    Adventist Hinsdale Hospital (IL) Neonatal Starter: Troph 4%Dex5% ,Trophamine 4% Dextrose 5%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a…
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-470-2015·2015-04-15

    Central Admixture Pharmacy Services Recalls TPN Neonatal Bags Due to Sterility Failure

    Central Admixture Pharmacy Services is recalling 12 bags of Virginia Hospital Center TPN Neonatal Day 1 Bags due to out-of-specification sterility test results indicating microbial contamination.

    Product
    Virginia Hospital Center (VA) TPN Neonatal Day 1 Bag, Trophamine 5.5 gm, Dextrose 10%, Additives: Calcium Gluconate 0.46mEq/mL, 600 mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with…
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-459-2015·2015-04-15

    CAPS Recalls Neonatal IV Infusion Bags Due to Sterility Failure

    Central Admixture Pharmacy Services is recalling two bags of a neonatal IV infusion compound because sterility testing failed.

    Product
    Robert Wood Johnson University (NJ) Neonatal Starter 5% Dextrose, Trophamine 5%, Dextrose 5%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-465-2015·2015-04-15

    Central Admixture Pharmacy Services Recalls Non-Sterile TPN Infusion Bags

    Central Admixture Pharmacy Services is recalling 3 bags of compounded TPN infusion bags due to non-sterility test failures.

    Product
    Bayshore Medical Center (TX) 10% Dextrose Starter Neo TPN, Trophamine 2.4% , Dextrose 10%, Additives: heparin PF 1 unit(s)/ml, Calcium Gluconate 2.3mEq/dL, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each…
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-460-2015·2015-04-15

    FDA Recalls 20 Neonatal TPN Bags Due to Sterility Test Failures

    Central Admixture Pharmacy Services is recalling 20 neonatal TPN bags because sterility tests showed microbial contamination.

    Product
    Virtua West Jersey Voorhees (NJ) TPN Neonatal Starter Bag, Trophamine 3% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, Calcium Gluconate 200mg/dL, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each…
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-462-2015·2015-04-15

    Central Admixture Pharmacy Services Recalls TPN Neonatal Starter Bags

    Central Admixture Pharmacy Services is recalling TPN Neonatal Starter IV infusion bags due to out-of-specification sterility test results.

    Product
    Abington Memorial Hospital (PA) TPN Neonatal Starter 0.4-0.599 Kg, Amino Acids, Neonate 3g, Dextrose 5%, 150 ml, Additives: heparin PF 75 units, Calcium Gluconate 300mg, compound vol: 150 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated…
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-449-2015·2015-04-15

    FDA Recalls Non-Sterile Neonatal TPN Bags Due to Microbial Contamination

    Central Admixture Pharmacy Services is recalling 10 bags of neonatal TPN due to failed sterility tests indicating microbial contamination.

    Product
    Holy Cross Hospital (MD) AA3%TPN Neonatal Day 1 Bag, Trophamine 10%/3% Dextrose 70%/10%, Additives: Calcium Gluconate 0.46 mEq/mL, 5mEq, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with…
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-442-2015·2015-04-15

    Central Admixture Pharmacy Services Recalls Non-Sterile Neonatal TPN Bags

    Central Admixture Pharmacy Services is recalling four bags of neonatal TPN solution due to failed sterility tests indicating microbial contamination.

    Product
    Bridgeport Hospital (CT)TPN Neonatal Standard Solution, Trophamine 6% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, Calcium Gluconate 4mEq/L, compound vol: 150 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is…
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-455-2015·2015-04-15

    Central Admixture Pharmacy Services Recalls Non-Sterile TPN Infusion Bags

    Central Admixture Pharmacy Services is recalling five bags of Truman Medical Center Lakewood Starter TPN due to out-of-specification sterility test results indicating microbial contamination.

    Product
    Truman Medical Center Lakewood (MO) Starter TPN, Trophamine 5.25g, Dextrose 10%, Additives: Calcium Gluconate 4.8mEq, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene…
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-450-2015·2015-04-15

    Central Admixture Pharmacy Services Recalls Non-Sterile Neonatal TPN Bags

    Central Admixture Pharmacy Services is recalling four bags of neonatal TPN due to non-sterility test failures. The product was distributed nationwide.

    Product
    Sinai Hospital (MD) TPN Neonatal Day 1 Bag, Trophamine 10 g, Dextrose 25 g, Additives: Calcium Gluconate 1500 mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert…
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-438-2015·2015-04-15

    Central Admixture Pharmacy Services Recalls TPN Neonate Starter Bags for Sterility Issues

    Central Admixture Pharmacy Services is recalling 10 bags of TPN Neonate Starter Bags due to out-of-specification sterility test results indicating microbial contamination.

    Product
    Children's Hospital Colorado Springs TPN Neonate Starter Bag 4% AA/10% DEX, Trophamine 4% Dextrose 10%, compound vol: 500 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS…
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-445-2015·2015-04-15

    Central Admixture Pharmacy Services Recalls Compounded TPN Infusion Bags

    Central Admixture Pharmacy Services is recalling 4 bags of compounded TPN infusion bags due to non-sterility test failures.

    Product
    Advocate Good Samaritan Hospital (IL) TPN Dextrose 5% Trophamine 2%, Trophamine 5% Dextrose 2%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown…
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-447-2015·2015-04-15

    Central Admixture Pharmacy Services Recalls Compounded TPN Bags Due to Sterility Failure

    Central Admixture Pharmacy Services is recalling three bags of compounded TPN due to out-of-specification sterility test results indicating microbial contamination.

    Product
    Methodist Hospital Northlake (IN) Neo Starter TPN D5, AA2, Trophamine 2% Dextrose 5%, Additives: heparin PF 100 units/mL, 50 units/dL, Calcium Gluconate 0.46 mEq/mL, 200 mg/dL, compound vol: 300 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a…
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-457-2015·2015-04-15

    FDA Recalls Non-Sterile Compounded Neonatal IV Infusion Bags

    Central Admixture Pharmacy Services is recalling 10 bags of compounded neonatal IV solution due to sterility test failures.

    Product
    Hackensack University Med Ctr (NJ) 5% Dextrose Neonatal Solution, Trophamine 3%, Dextrose 5%, Additives: Calcium Gluconate 0.46mEq/mL, 7mEq/L, compound vol: 150 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0434-2015·2015-04-15

    Wallcur Recalls Practi-0.9% Sodium Chloride Bags Due to Non-Sterility

    Wallcur Incorporated is recalling Practi-0.9% Sodium Chloride bags because they were manufactured in a non-sterile facility and are not intended for human or animal use.

    Product
    Practi-0.9% Sodium Chloride, 50 mL, 100 mL, 250 mL, 500 mL, and 1000 mL bags, Product of China, Wallcur, San Diego, CA, 92111, USA; Wallcur Practi Products for Clinical Simulation; NDCs 5108-0954-75, 5108-0954-71, 5108-0954-72, 5108-0954-74, 5108-0954-73.
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-0392-2015·2015-02-25

    Hospira Recalls Lactated Ringer's Injection Due to Confirmed Mold Particulates

    Hospira Inc. is recalling 142,644 bags of Lactated Ringer's and 5% Dextrose Injection USP due to confirmed mold particulates in the solution.

    Product
    LACTATED RINGER'S and 5% DEXTROSE Injection USP, 1000 mL, flexible containers, Rx Only, Hospira, Inc., Lake Forest, IL 600045, NDC 0409-7929-09
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0308-2015·2014-12-31

    Pharmacy Creations Recalls Non-Sterile Ophthalmic Solution

    Pharmacy Creations is recalling 50 bottles of Tropi/Cyclo/Phenyl/Tobra/Flurb sterile ophthalmic solution due to failing sterility test results.

    Product
    Tropi/Cyclo/Phenyl/Tobra/Flurb (1/1/10/0.3/0.03)% Sterile Ophthalmic Solution, 1 mL Dropper in a 3 mL bottle, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.
    Category
    Drug
    Distribution
    4 states
  • CriticalFDA (Drugs)·D-0306-2015·2014-12-31

    Glutathione Injection Recalled for Potential Non-Sterility

    Pharmacy Creations is recalling 12 vials of Glutathione 100mg/mL Sterile Injection due to failing sterility test results.

    Product
    Glutathione 100mg/mL Sterile Injection, 30 mL Multi Dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.
    Category
    Drug
    Distribution
    4 states
  • CriticalFDA (Drugs)·D-0305-2015·2014-12-31

    Pharmacy Creations Recalls Ascorbic Acid Injection Due to Sterility Failure

    Pharmacy Creations is recalling 67 vials of Ascorbic Acid 500 mg/mL Sterile Injection because contract testing indicated the product may not be sterile.

    Product
    Ascorbic Acid 500 mg/mL Sterile Injection, 50mL Multi-dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.
    Category
    Drug
    Distribution
    4 states
  • CriticalFDA (Drugs)·D-0307-2015·2014-12-31

    Pharmacy Creations Recalls Magnesium Chloride Injection Due to Sterility Concerns

    Pharmacy Creations is recalling 52 vials of Magnesium Chloride 20% Injection because contract testing indicated the product may not be sterile.

    Product
    Magnesium Chloride 20% (200mg/mL) Sterile Injection, 50mL Multi-Dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.
    Category
    Drug
    Distribution
    4 states
  • CriticalFDA (Drugs)·D-0252-2015·2014-11-26

    Abrams Royal Pharmacy Recalls Trace Mineral-5 MDV Due to Non-Sterility

    Abrams Royal Pharmacy is recalling Trace Mineral-5 MDV vials because a contract laboratory identified Staphylococcus warneri in the product, indicating non-sterility.

    Product
    Trace Mineral-5 MDV, supplied in 10 mL vials, Each ML contains: 1 mg Zinc (as sulfate), 0.4 mg Copper (as sulfate), 0.1 mg Manganese (as sulfate), 4 mcg Chromium (as chloride), 20 mcg Selenium (as sodium), 0.9% Benzyl alcohol in water for injection, Rx Only, Compounded…
    Category
    Drug
    Distribution
    Distributed nationwide