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-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 contain
    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-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 inser
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-451-2015·2015-04-15

    Central Admixture Pharmacy Services Recalls TPN Bags Due to Sterility Failure

    Central Admixture Pharmacy Services is recalling 5 bags of Total Parenteral Nutrition (TPN) compounded for Walter Reed National Military Medical Center because sterility tests failed.

    Product
    Walter Reed Natl Mil Med Ctr (MD) Stock TPN D10% without Ca, Trophamine 12g, Dextrose 20g, compound vol: 200 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-463-2015·2015-04-15

    FDA Recalls Six Bags of Neonatal TPN Due to Sterility Failure

    Central Admixture Pharmacy Services is recalling six bags of compounded neonatal TPN because sterility tests failed. The product was distributed nationwide.

    Product
    Abington Memorial Hospital (PA) TPN Neonatal Starter> 1Kg, Amino Acids, Neonate 12.5g, Dextrose 10%, 500 ml, Additives: heparin PF 250 units, Calcium Gluconate 1250mg, compound vol: 500 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box
    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 corru
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-437-2015·2015-04-15

    CAPS Recalls 20 Bags of TPN Neonatal Starter Bag for Sterility Failure

    Central Admixture Pharmacy Services is recalling 20 bags of University of Alabama Birmingham TPN Neonatal Starter Bag due to out-of-specification sterility test results.

    Product
    University of Alabama Birmingham TPN Neonatal Starter Bag, compound vol: 100 ml, Trophamine 4% Dextrose 10%, 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-467-2015·2015-04-15

    CAPS Recalls Neonatal TPN Bags Due to Sterility Test Failures

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

    Product
    Texas Health Presbyterian Dallas Neonatal Admit TPN 4 GM, Trophamine 4g/dL, 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-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, Allen
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-446-2015·2015-04-15

    CAPS Recalls Compounded TPN Infusion Bags Due to Sterility Failure

    Central Admixture Pharmacy Services is recalling four bags of compounded TPN infusion bags because they failed sterility tests for microbial contamination.

    Product
    Advocate Good Samaritan Hospital (IL) TPN Dextrose 10% Trophamine 2%, Trophamine 2% 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-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 a
    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 corr
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-444-2015·2015-04-15

    FDA Recalls Compounded Neonatal IV Infusion Bags Due to Sterility Failure

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

    Product
    Adventist Hinsdale Hospital (IL) Neonatal Starter: Troph 2% Dex10%, Trophamine 2% Dextrose 10%, 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 p
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-452-2015·2015-04-15

    Recall of Compounded TPN Bags Due to Sterility Test Failures

    Central Admixture Pharmacy Services is recalling five bags of compounded Total Parenteral Nutrition (TPN) because they failed sterility tests for microbial contamination.

    Product
    Walter Reed Natl Mil Med Ctr (MD) Stock TPN D10% with Ca, Trophamine 12g, Dextrose 20g, Additives: Calcium Gluconate 8mEq, compound vol: 200 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-439-2015·2015-04-15

    Central Admixture Pharmacy Services Recalls Compounded IV Infusion Bags

    Central Admixture Pharmacy Services is recalling 8 bags of compounded IV infusion bags due to out-of-specification sterility test results.

    Product
    Rose Medical Center (CO) Neonate D10 Bridge, Trophamine 3% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 350 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-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 lined
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-464-2015·2015-04-15

    CAPS Recalls Lankenau Hospital TPN Neonatal Starter Bags for Sterility Failure

    Central Admixture Pharmacy Services is recalling six Lankenau Hospital TPN Neonatal Starter Bags due to out-of-specification sterility test results.

    Product
    Lankenau Hospital (PA) TPN Neonatal Starter Bag, Trophamine 2.5%, Dextrose 10%, Additives: heparin PF 62.5 units, Calcium Gluconate 500mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined wit
    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 poly
    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-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-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-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 Medication
    Category
    Drug
    Distribution
    Distributed nationwide