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.

1251–1275 of 1691

  • SevereFDA (Drugs)·D-1652-2015·2015-09-23

    Testosterone Pellets Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Testosterone 62.5 mg Pellets because an FDA inspection found GMP violations that may affect sterility.

    Product
    Testosterone 62.5 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1609-2015·2015-09-23

    Morphine and Clonidine Solution Recalled for Sterility Concerns

    The Compounding Pharmacy of America is recalling Morphine and Clonidine solution due to FDA inspection findings regarding sterility assurance.

    Product
    Morphine 50 mg/ml + Clonidine 100 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1728-2015·2015-09-23

    Fentanyl and Bupivacaine Intrathecal Solution Recalled for Sterility Concerns

    The Compounding Pharmacy of America is recalling Fentanyl and Bupivacaine Intrathecal Solution due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Fentanyl 5,000 mcg/ml + Bupivacaine 40 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1499-2015·2015-09-23

    Fentanyl Intrathecal Solution Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Fentanyl 500 mcg/ml Intrathecal Solution due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Fentanyl 500 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1687-2015·2015-09-23

    Compounding Pharmacy Recalls LIPO-Tropic Injectable Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling LIPO-Tropic Injectable vials because FDA inspections found violations that may affect sterility.

    Product
    LIPO-Tropic Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1468-2015·2015-09-23

    Estradiol Pellets Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Estradiol 18 mg sterile pellets due to GMP violations that may impact sterility.

    Product
    Estradiol 18 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1465-2015·2015-09-23

    FDA Recalls Estradiol Pellets Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Estradiol 100 mg sterile pellets nationwide because FDA inspections found GMP violations that may impact sterility.

    Product
    Estradiol 100 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1651-2015·2015-09-23

    Testosterone Pellets Recalled for Potential Sterility Assurance Issues

    The Compounding Pharmacy of America is recalling Testosterone 50 mg Pellets because FDA inspections found GMP violations that may impact sterility.

    Product
    Testosterone 50 mg Pellet, Sterile, The Compounding Pharmacy of America, Inc., Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1478-2015·2015-09-23

    Estradiol Valerate Injectable Vials Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Estradiol Valerate 20 mg/ml injectable vials due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Estradiol Valerate 20 mg/ml Injectable ml Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1584-2015·2015-09-23

    Mitomycin Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Mitomycin Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Mitomycin 40 mg/50 ml Sodium Chloride 0.9% Injection, Single Dose Syringe, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1694-2015·2015-09-23

    Lipovicine Modified II Injectable Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Lipovicine Modified II Injectable due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Lipovicine Modified II Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1722-2015·2015-09-23

    Tri-Mix Injectable Recalled for Potential Sterility Issues

    The Compounding Pharmacy of America is recalling Tri-Mix injectable vials because FDA inspections found GMP violations that may affect sterility.

    Product
    Tri-Mix (15 mg/0.5 mg/20 mcg) Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1476-2015·2015-09-23

    Estradiol Pellets Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Estradiol 8 mg sterile pellets due to GMP violations that may impact sterility.

    Product
    Estradiol 8 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1497-2015·2015-09-23

    Fentanyl and Bupivacaine Intrathecal Solution Recalled for Sterility Concerns

    The Compounding Pharmacy of America is recalling Fentanyl and Bupivacaine intrathecal solution due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Fentanyl 5,000 mcg/ml, + Bupivacaine 15 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1474-2015·2015-09-23

    Estradiol Pellets Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Estradiol 50 mg sterile pellets because FDA inspections found GMP violations that may impact sterility.

    Product
    Estradiol 50 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1674-2015·2015-09-23

    FDA Recalls Intrathecal Solution Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling a specific intrathecal solution because an FDA inspection found GMP violations that may impact sterility.

    Product
    Hydromorphone 45 mg/ml + Fentanyl 10,000 mcg/ml + Bupivacaine 15 mg/ml + Baclofen 720 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1437-2015·2015-09-23

    Alprostadil Injection Recalled for Potential Sterility Issues

    The Compounding Pharmacy of America is recalling Alprostadil 100 mcg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Alprostadil 100 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1634-2015·2015-09-23

    Sodium Ascorbate Injection Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Sodium Ascorbate 500 mg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Sodium Ascorbate 500 mg/ml Injection, Preservative Free Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1551-2015·2015-09-23

    FDA Recalls Hydromorphone and Bupivacaine Solution Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Hydromorphone and Bupivacaine solution because FDA inspections found GMP violations that may affect sterility.

    Product
    Hydromorphone 40 mg/ml + Bupivacaine 40 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1450-2015·2015-09-23

    Cholecalciferol Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Cholecalciferol 50,000 IU/ml Injectable vials because FDA inspections identified GMP violations that may impact sterility.

    Product
    Cholecalciferol 50,000 IU/ml Injectable, Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1769-2015·2015-09-23

    Tri-Mix Injectable Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling Tri-Mix injectable products due to FDA inspection findings of GMP violations that impact sterility.

    Product
    Tri-Mix (20/1/10) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1628-2015·2015-09-23

    Selenium Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Selenium 200 mcg/ml Injectable due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Selenium 200 mcg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1641-2015·2015-09-23

    Testosterone Cypionate Injection Recalled Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Testosterone Cypionate 150 mg/ml Injection due to lack of assurance of sterility identified during an FDA inspection.

    Product
    Testosterone Cypionate 150 mg/ml Injection Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1562-2015·2015-09-23

    Lidocaine 1% Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Lidocaine 1% Injection because FDA inspections found GMP violations that may affect sterility.

    Product
    Lidocaine 1% Injection, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1561-2015·2015-09-23

    L-Arginine Injectable Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling L-Arginine 100 mg/ml Injectable due to FDA inspection findings of GMP violations that impact sterility.

    Product
    L-Arginine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide