The Recall Desk

Hazard

Sterility Failure recalls

1,691 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,691
Critical
12
Severe
931
Most recent
2026-07-29

Of the 1,691 sterility failure recalls we have scored against our rubric, 12 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 931 (55%) 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 failure 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.

1326–1350 of 1691

  • CriticalFDA (Drugs)·D-466-2015·2015-04-15

    Central Admixture Pharmacy Recalls Compounded IV Infusion Bags for Sterility Failure

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

    Product
    Bayshore Medical Center (TX) 5% Dextrose Starter Neo TPN, Trophamine 2.4% , Dextrose 5%, 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 contain
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-468-2015·2015-04-15

    FDA Recalls Two Bags of Neonatal TPN Due to Sterility Failure

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

    Product
    Spotsylvania Regional Med Ctr (VA) TPN Neonatal Starter Bag with Calcium, Trophamine 5 gm, Dextrose 10%, Additives: Calcium Gluconate 0.46 mEq/mL, 750mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each contai
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-454-2015·2015-04-15

    CAPS Recalls Trophamine IV Infusion Bags Due to Sterility Failure

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

    Product
    St Lukes East Lees Summit (MO) Protein Bag,Trophamine 5g, Dextrose 10%, Additives: Calcium Gluconate 4.65mEq, 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,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1364-2015·2015-04-08

    Biomet Recalls Ziploop Button and ToggleLocs Due to Packaging Seal Issues

    Biomet, Inc. is recalling 50 units of Ziploop Buttons and ToggleLocs manufactured in 2014 because sterile packaging was not properly sealed.

    Product
    Ziploop Button Product Usage: The Ziploop Button is a non-resorbable system intended to aid in ACL reconstructive procedure due to injury or degenerative disease
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1234-2015·2015-03-11

    Zipline Medical Recalls Zip 8i Surgical Skin Closure Devices

    Zipline Medical is recalling Zip 8i Surgical Skin Closure Devices because the manufacturer's seal may be missing, compromising sterility assurance.

    Product
    Zip 8i Surgical Skin Closure Device; for incisions up to 8 cm. Product number PS2080 Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0374-2015·2015-01-28

    Walgreens Recalls L-cysteine Infusions Due to Sterility Concerns

    Walgreens Infusion Services is recalling L-cysteine products due to a lack of sterility assurance. The affected products were distributed in six southern states.

    Product
    L-cysteine various strengths
    Category
    Drug
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0366-2015·2015-01-28

    Walgreens Recalls Folic Acid Syringes Due to Sterility Concerns

    Walgreens Infusion Services is recalling folic acid pre-drawn syringes due to a lack of sterility assurance. The products were distributed in six states.

    Product
    Folic acid 1 mg/ 0.2 ml pre-drawn syringes
    Category
    Drug
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0344-2015·2015-01-28

    Walgreens Recalls Cefoxitin Infusion Bags Due to Sterility Concerns

    Walgreens Infusion Services is recalling Cefoxitin in normal saline bags due to a lack of sterility assurance. The products were distributed in six states.

    Product
    Cefoxitin various strength in normal saline bags
    Category
    Drug
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0347-2015·2015-01-28

    Walgreens Recalls Ertapenem Infusion Bags Due to Sterility Concerns

    Walgreens Infusion Services is recalling Ertapenem in normal saline bags due to a lack of sterility assurance. The products were distributed in six states.

    Product
    Ertapenem various strength in normal saline bags
    Category
    Drug
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0357-2015·2015-01-28

    Walgreens Recalls Ceftriaxone Infusions Due to Sterility Concerns

    Walgreens Infusion Services is recalling ceftriaxone in normal saline due to a lack of sterility assurance. The products were distributed in six states.

    Product
    Ceftriaxone various strengths in normal saline
    Category
    Drug
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0342-2015·2015-01-28

    Walgreens Recalls Aztreonam Infusions Due to Sterility Concerns

    Walgreens Infusion Services is recalling Aztreonam 1 gram in normal saline due to a lack of sterility assurance. The affected products were distributed in six states.

    Product
    Aztreonam 1 gram in normal saline
    Category
    Drug
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0360-2015·2015-01-28

    Walgreens Recalls Tigecycline Infusions Due to Sterility Concerns

    Walgreens Infusion Services is recalling Tigecycline in normal saline due to a lack of sterility assurance. The products were distributed in six southern states.

    Product
    Tigecycline various strengths in normal saline
    Category
    Drug
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0349-2015·2015-01-28

    Walgreens Recalls Vancomycin Infusion Bags Due to Sterility Concerns

    Walgreens Infusion Services is recalling Vancomycin in normal saline bags due to a lack of sterility assurance. The products were distributed in six states.

    Product
    Vancomycin various strengths in normal saline bags
    Category
    Drug
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0368-2015·2015-01-28

    Walgreens Recalls Ranitidine Syringes Due to Sterility Assurance Concerns

    Walgreens Infusion Services is recalling various strengths of ranitidine syringes because of a lack of sterility assurance. The products were distributed in six states.

    Product
    Ranitidine various strengths in syringes
    Category
    Drug
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0345-2015·2015-01-28

    Walgreens Recalls Ceftazidime Infusion Bags Due to Sterility Concerns

    Walgreens Infusion Services is recalling Ceftazidime in normal saline bags due to a lack of sterility assurance. The products were distributed in six states.

    Product
    Ceftazidime various strength in normal saline bags
    Category
    Drug
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0312-2015·2014-12-31

    Vann Healthcare Pharmacy Recalls Tri-mix #4 Due to Sterility Concerns

    Vann Healthcare Pharmacy is recalling Tri-mix #4 vials because an FDA inspection found deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility.

    Product
    Tri-mix #4 (Papaverine 30 mg, Phentolamine 1 mg, Prostaglandin-1 10 mcg/mL), packaged in 10 mL sterile glass vials, Rx, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0303-2015·2014-12-24

    Hospira Recalls Meropenem I.V. Vials Due to Defective Glass

    Hospira Inc. is recalling Meropenem I.V. 1 g vials because thin glass walls may crack, leading to contamination and sterility issues.

    Product
    Meropenem I.V. 1 g is supplied in 30 mL injection vials, RX only. Manufactured by Hospira Healthcare India Pvt. Ltd Tamil Nadu, India for Hospira, Inc. 275 N. Field Drive, Lake Forest, IL 60045. NDC 0409-3506-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0492-2015·2014-12-10

    Ethicon Recalls PERMA-HAND Silk Suture Due to Sterility Assurance Concerns

    Ethicon is recalling PERMA-HAND silk sutures because the company cannot ensure the products meet the expected sterility assurance level.

    Product
    Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0271-2015·2014-12-03

    Perry Drug Recalls Cyclosporine Eye Drops Due to Sterility Concerns

    Perry Drug Inc. is recalling Cyclosporine 0.045% eye drops due to potential sterility assurance issues identified during an FDA inspection.

    Product
    Cyclosporine 0.045 % Sol PF, 12 mL bottle, Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5120-67
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0286-2015·2014-12-03

    Hospira Recalls 0.45% Sodium Chloride Injection Due to Sterility Concerns

    Hospira is recalling 784,920 bags of 0.45% Sodium Chloride Injection because punctures in the packaging may compromise sterility and cause leaks.

    Product
    0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7985-09.
    Category
    Drug
    Distribution
    Distributed nationwide