The Recall Desk

Hazard

Sterility recalls

2,384 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,384
Critical
1
Severe
2,114
Most recent
2026-09-09

Of the 2,384 sterility recalls we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,114 (89%) 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 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.

1801–1825 of 2384

  • SevereFDA (Drugs)·D-1704-2015·2015-09-23

    FDA Recalls Morphine, Clonidine, and Bupivacaine Solution Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling a sterile solution containing morphine, clonidine, and bupivacaine because an FDA inspection found GMP violations that may impact sterility.

    Product
    Morphine 50 mg/ml + Clonidine 500 mcg/ml +Bupivacaine 2.5 mg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1751-2015·2015-09-23

    Testosterone Pellets Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Testosterone 87.5 mg Sterile Pellets because FDA inspections identified GMP violations that may impact sterility.

    Product
    Testosterone 87.5 mg Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1791-2015·2015-09-23

    Compounded Injectable Tri-Mix Recalled for Sterility Assurance Concerns

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

    Product
    Tri-Mix MEDIUM (15/0.5/5) (MFG) Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1479-2015·2015-09-23

    Estradiol Valerate Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Estradiol Valerate 40 mg/ml injectable vials because FDA inspections found GMP violations that may impact sterility.

    Product
    Estradiol Valerate 40 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1523-2015·2015-09-23

    HCG Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling HCG 1,250 IU/ml Injection vials because FDA inspections identified GMP violations that may impact sterility.

    Product
    HCG 1,250 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1678-2015·2015-09-23

    FDA Recalls Compounded Intrathecal Pain Medication Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling a compounded intrathecal pain medication because FDA inspections found GMP violations that may affect sterility.

    Product
    Hydromorphone 60 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 35 mg/ml + Clonidine 1,200 mcg/ml + Baclofen 90 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1732-2015·2015-09-23

    FDA Recalls Compounded Intrathecal Solution Due to Sterility Concerns

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

    Product
    Hydromorphone 80 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml + Baclofen 750 mcg/ml Intrathecal Solution, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1691-2015·2015-09-23

    Lipotropic B-12 Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Lipotropic B-12 Injection vials because an FDA inspection found GMP violations that may affect sterility.

    Product
    Lipotropic B-12 Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1755-2015·2015-09-23

    Testosterone Cypionate Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Testosterone Cypionate 250 mg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Testosterone Cypionate 250 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1779-2015·2015-09-23

    Tri-Mix Injectable Recalled for Potential Sterility Issues

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

    Product
    Tri-Mix (30/1/20) (MFG) Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1796-2015·2015-09-23

    Tri-Mix ST4 Injectable Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Tri-Mix ST4 Injectable due to GMP violations that may impact sterility. The recall covers lots distributed nationwide from November 2014 to May 2015.

    Product
    Tri-Mix ST4 (3 mg/1.5 mg/300 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1697-2015·2015-09-23

    FDA Recalls MEGA-BURN Injectable Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling MEGA-BURN Injectable ROCK CREEK because FDA inspections found GMP violations that may impact sterility.

    Product
    MEGA-BURN Injectable ROCK CREEK, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1582-2015·2015-09-23

    Mitomycin Ophthalmic Solution Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Mitomycin 0.03% Ophthalmic Solution due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Mitomycin 0.03% Ophthalmic Solution, ml single dose dropper, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1701-2015·2015-09-23

    FDA Recalls Morphine and Bupivacaine Compounded Solution Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Morphine, Bupivacaine, and Clonidine solution due to FDA inspection findings of GMP violations affecting sterility.

    Product
    Morphine 25 mg/ml + Bupivacaine 20 mg/ml + Clonidine 2,000 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1466-2015·2015-09-23

    Estradiol Pellets Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Estradiol 12.5 mg sterile pellets because FDA inspections found GMP violations that may affect sterility.

    Product
    Estradiol 12.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1762-2015·2015-09-23

    Tri-Mix Injectable Recalled Due to Sterility Assurance Concerns

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

    Product
    Tri-Mix (15 mg/0.5 mg/5 mcg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1524-2015·2015-09-23

    HCG Injection Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling HCG 11,000 IU/ml Injection vials because FDA inspections found GMP violations that may impact sterility.

    Product
    HCG 11,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1653-2015·2015-09-23

    FDA Recalls Testosterone Pellets Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Testosterone 70 mg Pellets because an FDA inspection found GMP violations that may affect sterility.

    Product
    Testosterone 70 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1480-2015·2015-09-23

    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 10,000 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-1801-2015·2015-09-23

    FDA Recalls Tri-Mix Injectable Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Tri-Mix ST9E injectable products because an FDA inspection found violations that may affect sterility.

    Product
    Tri-Mix ST9E (60 mg/4 mg/150 mcg) Injectable, Sterile Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1670-2015·2015-09-23

    FDA Recalls Hydromorphone and Clonidine Intrathecal Solution Due to Sterility Concerns

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

    Product
    Hydromorphone 20 mg/ml + Clonidine 1,000 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1726-2015·2015-09-23

    B-Complex Injection Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling B-Complex 100 mg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    B-Complex 100 mg/ml Injection, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1803-2015·2015-09-23

    FDA Recalls Tri-Mix Injectable Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Tri-Mix T-101 Injectable due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Tri-Mix T-101 (17.65 mg/0.59 mg/5.9 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1460-2015·2015-09-23

    Cyanocobalamin and B-Complex Injection Recalled for Sterility Concerns

    The Compounding Pharmacy of America is recalling Cyanocobalamin and B-Complex injections due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Cyanocobalamin 1,000 mcg/ml + B-Complex 500 mg/ml, ml, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1638-2015·2015-09-23

    FDA Recalls Sufentanil and Bupivacaine Solution Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Sufentanil and Bupivacaine solution because FDA inspections found violations that may have compromised sterility.

    Product
    Sufentanil 50 mcg/ml + Bupivacaine 0.25 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide