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.

851–875 of 1691

  • SevereFDA (Drugs)·D-0464-2019·2019-02-20

    Promise Pharmacy Recalls IGF-1-LR3 Injections Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling 59 vials of IGF-1-LR3, 3 mg injection due to a lack of sterility assurance. The product was distributed nationwide in the USA.

    Product
    IGF-1-LR3, 3 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0473-2019·2019-02-20

    Promise Pharmacy Recalls Trim Calm Vials Due to Sterility Concerns

    Promise Pharmacy is recalling 7 vials of Trim Calm due to a lack of sterility assurance. The product was distributed nationwide in the USA.

    Product
    Trim Calm, GABA/Magnesium/Taurine/Theanine, 50mg/50mg/50mg/50mg/ml, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0481-2019·2019-02-20

    Promise Pharmacy Recalls Folic Acid Injection Due to Sterility Concerns

    Promise Pharmacy is recalling Folic Acid 5mg/ml injections because the product lacks sterility assurance. The recall covers nationwide distribution.

    Product
    Folic Acid, 5mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0458-2019·2019-02-20

    Promise Pharmacy Recalls Bremelanotide Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 64 vials of Bremelanotide 20mg injections nationwide due to a lack of sterility assurance.

    Product
    Bremelanotide (PT 141), 20mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0440-2019·2019-02-20

    Promise Pharmacy Recalls Vitamin D3 Injections Due to Sterility Concerns

    Promise Pharmacy is recalling specific lots of Vitamin D3 50,000iu/mL injections nationwide due to a lack of sterility assurance.

    Product
    Vitamin D3 50,000iu/mL, injection 5 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0477-2019·2019-02-20

    Promise Pharmacy Recalls Lysine HCl Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling 11 vials of Lysine HCl injection due to a lack of sterility assurance. The affected lot was distributed nationwide.

    Product
    Lysine HCl, 100 mg/mL injection, 10ml, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0722-2019·2019-02-13

    Medline Prefilled 550 ml Sterile Bags Recalled for Leaking

    Medex Cardio-Pulmonary Inc. is recalling 54,924 Medline Prefilled 550 ml Sterile bags due to leaking containers that may compromise sterility.

    Product
    Medline Prefilled 550 ml Sterile¿¿ ¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0712-2019·2019-02-13

    Smiths Medical Recalls Portex Sterile Water Pour Bottles Due to Leaking

    Smiths Medical is recalling Portex 1000 ml Sterile Water USP Pour Bottles because leaking containers may lack sterility assurance, posing a risk of exposure to infectious agents.

    Product
    Portex 1000 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0715-2019·2019-02-13

    Smiths Medical Recalls Portex Sterile Water Humidifiers Due to Leaking

    Smiths Medical is recalling Portex 550 ml Sterile Water Humidifiers because leaking containers may compromise sterility, potentially exposing patients to infectious agents.

    Product
    Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿¿ ¿¿¿ ¿¿¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0713-2019·2019-02-13

    Smiths Medical Recalls Portex Sterile Water Pour Bottles Due to Leaking

    Smiths Medical is recalling Portex 500 ml Sterile Water USP Pour Bottles because leaking containers may compromise sterility and expose users to infectious agents.

    Product
    Portex 500 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0714-2019·2019-02-13

    Smiths Medical Recalls Intermed 350 ml Sterile Water Humidifiers

    Smiths Medical is recalling Intermed 350 ml Sterile Water Humidifiers due to leaking containers that may compromise sterility and expose patients to infectious agents.

    Product
    Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ ¿¿¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0719-2019·2019-02-13

    Smiths Medical Recalls Portex Unit Dose Normal Saline Due to Sterility Concerns

    Smiths Medical is recalling Portex Unit Dose 5 ml Normal Saline because leaking containers may lack sterility assurance, posing a risk of exposure to infectious agents.

    Product
    Portex Unit Dose 5 ml Normal Saline (0.9%)¿¿¿¿ ¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0720-2019·2019-02-13

    Smiths Medical Recalls Portex Normal Saline Units Due to Sterility Concerns

    Smiths Medical is recalling Portex Unit Dose 15 ml Normal Saline products because leaking containers may compromise sterility, potentially exposing patients to infectious agents.

    Product
    Portex Unit Dose 15 ml Normal Saline ¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0721-2019·2019-02-13

    Smiths Medical Recalls Portex 5ml Normal Saline Units Due to Sterility Issues

    Smiths Medical is recalling 106,000 units of Portex 5ml Normal Saline due to leaking containers that may compromise sterility and expose patients to infectious agents.

    Product
    Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0351-2019·2019-01-16

    Baxter Recalls Dianeal Low Calcium Dialysis Solution Due to Sterility Concerns

    Baxter Healthcare is recalling 29,370 bags of Dianeal Low Calcium peritoneal dialysis solution because confirmed customer complaints identified leaks in the tubing, compromising sterility.

    Product
    DIANEAL LOW CALCIUM WITH DEXTROSE — DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0360-2019·2018-12-26

    Lubrisine eye drops recalled for undeclared colloidal silver and sterility issues

    Results RNA, LLC is recalling Lubrisine eye drops nationwide due to lack of sterility assurance and the presence of undeclared colloidal silver.

    Product
    Lubrisine eye drops (polyethylene glycol 400 0.4% and Propylene glycol 0.3%), 30 ML bottle, Manufactured and Distributed by: Results RNA, LLC, 1272 S 1380 W., Orem, UT 84058, UPC 7 9238230723 4
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0343-2019·2018-12-26

    Pharm D Solutions Recalls Human Chorionic Gonadotropin Vials Due to Sterility Concerns

    Pharm D Solutions is recalling 85 vials of Human Chorionic Gonadotropin 3000 IU due to inadequate processes to assure sterility.

    Product
    Human Chorionic Gonadotropin 3000 IU, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054 1-844-263-6843 --- NDC: 69699-1738-10
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0232-2019·2018-11-14

    Recall of Testosterone 12.5mg Pellet due to Sterility Concerns

    Qualgen, LLC is recalling Testosterone 12.5mg pellets nationwide because the sterility of the product cannot be assured. Consumers should stop using the affected lots and contact the manufacturer or pharmacist.

    Product
    Testosterone 12.5mg pellet, 1 count (NDC 69761-112-01), 6 count (NDC 69761-112-06), 12 count (NDC 69761-112-12), and 30 count (NDC 69761-112-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0228-2019·2018-11-14

    Qualgen Recalls Estradiol Pellets Due to Sterility Assurance Concerns

    Qualgen, LLC is recalling Estradiol 18mg pellets because the company cannot assure the sterility of the product. The recall covers specific vial sizes distributed nationwide.

    Product
    Estradiol 18mg pellet, 1 count (NDC 69761-018-01), 6 count (NDC 69761-018-06), 12 count (NDC 69761-018-12), and 30 count (NDC 69761-018-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0231-2019·2018-11-14

    Qualgen Recalls Testosterone Pellets Due to Sterility Concerns

    Qualgen, LLC is recalling specific lots of Testosterone 100mg pellets nationwide due to a lack of assurance of sterility.

    Product
    Testosterone 100mg pellet, 1 count (NDC 69761-110-01), 6 count (NDC 69761-110-06), 12 count (NDC 69761-110-12), and 30 count (NDC 69761-110-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0153-2019·2018-11-07

    Pharm D Solutions Recalls Glutamine Solution Due to Sterility Concerns

    Pharm D Solutions is recalling Glutamine 10 mg/mL Solution because the product lacks assurance of sterility. The recall covers specific lots distributed nationwide.

    Product
    Glutamine 10 mg/mL Solution, Pharm D Solutions, Houston, Texas ---- NDC 69699-1439-59
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0204-2019·2018-11-07

    Pharm D Solutions Recalls Trimix ST-9B Due to Sterility Concerns

    Pharm D Solutions is recalling specific lots of Trimix ST-9B aqueous solution because the company cannot guarantee the product's sterility.

    Product
    Trimix ST-9B 30 PA-2PH-100A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1344-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0180-2019·2018-11-07

    Pharm D Solutions Recalls Sermorelin/GHRP-2 Powder Due to Sterility Concerns

    Pharm D Solutions is recalling 409 vials of Sermorelin/GHRP-2 powder because the company cannot ensure the product is sterile.

    Product
    Sermorelin/GHRP-2 6 mg/6 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1727-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0154-2019·2018-11-07

    Pharm D Solutions Recalls Glutathione Solution Due to Sterility Concerns

    Pharm D Solutions is recalling 4,000 mL of Glutathione 200 mg/mL Solution because the product lacks assurance of sterility.

    Product
    Glutathione 200 mg/mL Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-1504-30
    Category
    Drug
    Distribution
    Distributed nationwide