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.

1101–1125 of 1691

  • SevereFDA (Drugs)·D-0990-2016·2016-06-15

    FDA Recalls Compounded HCG and Vitamin Injections for Sterility Concerns

    Well Care Compounding Pharmacy is recalling compounded HCG, methylcobalamin, and folic acid injections due to FDA inspection findings regarding sterility assurance.

    Product
    HCG/METHYLCOBALAMIN/FOLIC ACID,1000IU/5MG/0.4MG/ML; packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0986-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls Sterility-Compromised Glutathione Vials

    Well Care Compounding Pharmacy is recalling 869 vials of Glutathione 100mg/mL due to FDA-identified GMP violations that may compromise sterility.

    Product
    GLUTATHIONE 100MG/ML, packaged in 10 mL vials, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0981-2016·2016-06-15

    FDA Recalls Estradiol Cypionate Vials Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling Estradiol Cypionate 10 mg/mL vials because FDA inspections found GMP violations that may affect sterility.

    Product
    ESTRADIOL CYPIONATE 10 MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-1022-2016·2016-06-15

    Vancomycin Ophthalmic Solution Recalled for Sterility Assurance Concerns

    Well Care Compounding Pharmacy is recalling Vancomycin 50mg/mL ophthalmic solution due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    VANCOMYCIN 50MG/ML OPHTH SOLUTION; packaged in 10mL vial, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-1023-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls Vitamin B Complex Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling Vitamin B Complex # 1 vials because FDA inspections found GMP violations that may affect sterility.

    Product
    VITAMIN B COMPLEX # 1; packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0993-2016·2016-06-15

    FDA Recalls Compounded L-Glutamine Injection Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling compounded L-Glutamine/L-Arginine/L-Carnitine injections due to FDA inspection findings regarding sterility assurance.

    Product
    L-GLUT/L-ARG/L-CARN; 25MG/100MG/200MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0995-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls M.I.C. Injection Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling M.I.C. /MB12/B6/DEXPLAN/L-CARN injection vials because FDA inspections found GMP violations that may affect sterility.

    Product
    M.I.C. /MB12/B6/DEXPLAN/L-CARN, 25MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-1008-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls QUAD-MIX #4 Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling QUAD-MIX #4 (MOD) vials because FDA inspections found violations that may affect product sterility.

    Product
    QUAD-MIX #4 (MOD), packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-1011-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls Testosterone Cypionate Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling Testosterone Cypionate 100mg/mL vials because FDA inspections found GMP violations that may affect sterility.

    Product
    TESTOSTERONE CYPIONATE 100MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0937-2016·2016-06-08

    Baptist Health Recalls Sodium Chloride IV Bags Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling seven bags of Sodium Chloride 0.9% IV solution in Arkansas due to a lack of sterility assurance.

    Product
    Sodium Chloride 0.9% 1000 mL with Electrolytes bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0944-2016·2016-06-08

    Baptist Health Recalls Vancomycin IV Bags Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling 84 bags of Vancomycin 1250 mg in 250 mL 0.9% NS due to lack of sterility assurance.

    Product
    Vancomycin 1250 mg in 250 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0943-2016·2016-06-08

    Baptist Health Recalls Vancomycin IV Bags Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling 59 bags of Vancomycin 1000 mg in 250 mL 0.9% NS due to a lack of sterility assurance.

    Product
    Vancomycin 1000 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0949-2016·2016-06-08

    Akorn Recalls Sulfacetamide Sodium Ophthalmic Solution Due to Sterility Concerns

    Akorn, Inc. is recalling specific lots of Sulfacetamide Sodium Ophthalmic Solution because they failed antimicrobial effectiveness testing, raising concerns about sterility.

    Product
    Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd. by: Akorn, Inc., Lake Forest, IL 60045 --- NDC 17478-221-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0940-2016·2016-06-08

    Baptist Health Recalls Water for Injection Bags Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling 7 bags of Water for Injection in Arkansas due to a lack of sterility assurance.

    Product
    Water for Injection 1000 mL Bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock Arkansas
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0946-2016·2016-06-08

    Baptist Health Recalls Vancomycin IV Bags Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling 54 bags of Vancomycin 1750 mg in 270 mL 0.9% NS due to a lack of sterility assurance. The product was distributed in Arkansas.

    Product
    Vancomycin 1750 mg in 270 mL 0.9% NS bag,FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0923-2016·2016-06-08

    Baptist Health Recalls Deferoxamine Cassettes Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling three Deferoxamine cassettes in Arkansas due to a lack of sterility assurance.

    Product
    Deferoxamine 4 grams/NS 101 mL Cassette, FOR SUBCUTANEOUS USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1882-2016·2016-06-08

    Greatbatch Medical Recalls Torque Limiting Handles Due to Sterility Failure

    Greatbatch Medical is recalling torque limiting handles because laboratory testing showed they do not meet required sterility levels after steam sterilization.

    Product
    Torque Limiting Handle: PRECIMED, T-Handle Torque, Non Sterile. Handle: Customer Number/Model: MCL120014 T14000, TLT911-50-S20 TLT911-50-S20, TLT911-15-S01 TLT911-15-S01, TLTS0007-20-S19 TLTS0007-20-S19, TLT911-35-S01 TLT911-35-S01.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1884-2016·2016-06-08

    Greatbatch Recalls Torque Limiting Devices Due to Sterility Assurance Failure

    Greatbatch Medical is recalling torque limiting devices because laboratory testing showed they do not meet required sterility levels after steam sterilization.

    Product
    Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distributed by Zimmer. PRECIMED, Torque Limiting Adaptor, Non Sterile.. Customer Number/Model: 00-2360-080-00 T10232, T116245 T116245, TLA025-25 TLA025-25, 00-2360-080-05 T10233, MAC21003 T116430,
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Drugs)·D-0911-2016·2016-06-08

    Baptist Health Recalls Sodium Chloride IV Bags Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling 0.9% Sodium Chloride IV bags in Arkansas due to a lack of sterility assurance.

    Product
    0.9% Sodium Chloride a) 500 mL b) 2000 mL and c) 3000 mL bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1883-2016·2016-06-08

    Greatbatch Medical Recalls Torque Limiting Devices Due to Sterility Failure

    Greatbatch Medical is recalling torque limiting devices because laboratory testing showed they do not achieve the required sterility assurance level when steam sterilized.

    Product
    Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only. PRECIMED, Non Sterile. Zimmer, Non Sterile, Rx Only. Screwdriver: Customer Number/Model: 804-03-038 T11623, T14001 T14001, MTO35173507 T14378, MTO375173506 T14379,
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Drugs)·D-0941-2016·2016-06-08

    Baptist Health Recalls Vancomycin Bags Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling Vancomycin IV bags in Arkansas due to a lack of sterility assurance.

    Product
    Vancomycin 500 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1460-2016·2016-04-20

    Customed Laparotomy Packs Recalled for Sterilization Validation Defects

    Customed, Inc. is recalling 597 laparotomy packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900281A LAPAROTOMY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0803-2016·2016-04-13

    Meditech Formula 4 Injection Recalled for Sterility Assurance Issues

    Meditech Laboratories is recalling Formula 4 Injection vials due to incomplete data regarding production sterility.

    Product
    Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102. .
    Category
    Drug
    Distribution
    Distributed nationwide