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.

1276–1300 of 1691

  • SevereFDA (Drugs)·D-1573-2015·2015-09-23

    Methylcobalamin Injection Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling Methylcobalamin 25,000 mcg/ml injections due to FDA inspection findings of GMP violations that impact sterility.

    Product
    Methylcobalamin 25,000 mcg/ml Intramuscular, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1747-2015·2015-09-23

    Testosterone Pellets Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Testosterone 30 mg sterile pellets nationwide because FDA inspections found GMP violations that may affect sterility.

    Product
    Testosterone 30 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1744-2015·2015-09-23

    Testosterone Pellets Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Testosterone 20 mg sterile pellets due to GMP violations that may impact sterility.

    Product
    Testosterone 20 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1682-2015·2015-09-23

    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 affect sterility.

    Product
    Hydromorphone 80 mg/ml + Bupivacaine 10 mg/ml + Clonidine 1,000 mcg/ml, Baclofen 500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1586-2015·2015-09-23

    Morphine Solution Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Morphine 12.5 mg/ml Solution due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Morphine 12.5 mg/ml Solution, Sterile-Preservative Free,The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1709-2015·2015-09-23

    FDA Recalls Compounded Morphine, Fentanyl, and Baclofen Injection for Sterility Concerns

    The FDA is recalling compounded morphine, fentanyl, and baclofen injections due to GMP violations that may compromise sterility. The recall covers lots distributed nationwide between November 2014 and May 2015.

    Product
    Morphine 50 mg/ml + Fentanyl 3,000 mcg/ml + Baclofen 450 mcg/ml, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1489-2015·2015-09-23

    Fentanyl Intrathecal Solution Recalled Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Fentanyl 1,000 mcg/ml Intrathecal Solution because FDA inspections found GMP violations that may affect sterility.

    Product
    Fentanyl 1,000 mcg/ml Intrathecal Solution, Sterile-Preservative Free,The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1475-2015·2015-09-23

    Estradiol Pellets Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Estradiol 6 mg sterile pellets nationwide because FDA inspections found GMP violations that may impact sterility.

    Product
    Estradiol 6 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1654-2015·2015-09-23

    Testosterone Pellets Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling Testosterone 72.5 mg Pellets due to FDA inspection findings of GMP violations that impact sterility.

    Product
    Testosterone 72.5 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1455-2015·2015-09-23

    Collagenase Recall Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Collagenase 250 units/ml vials because FDA inspections found GMP violations that may affect sterility.

    Product
    Collagenase 250 units/ml, Sterile, Multi-Dose Vial, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1535-2015·2015-09-23

    Hyaluronic Acid Injection Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Hyaluronic Acid Sodium and Lidocaine HCl Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Hyaluronic Acid Sodium 32 mg/ml + Lidocaine HCl 3 mg/ml Injection, ml Syringe, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1737-2015·2015-09-23

    Morphine and Bupivacaine Solution Recalled for Sterility Assurance Issues

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

    Product
    Morphine 40 mg/ml + Bupivacaine 8 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1509-2015·2015-09-23

    Compounded HCG and Methylcobalamin Injection Recalled for Sterility Concerns

    The Compounding Pharmacy of America is recalling HCG and Methylcobalamin injections due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    HCG 1,100 IU/ml + Methylcobalamin 0.5 mg/ml Injection, ml Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1759-2015·2015-09-23

    Testosterone Cypionate Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Testosterone Cypionate 40 mg/ml Injectable due to FDA inspection findings regarding sterility assurance.

    Product
    Testosterone Cypionate 40 mg/ml Injectable, 5 Sesame, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1602-2015·2015-09-23

    Morphine and Clonidine Solution Recalled for Sterility Assurance Issues

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

    Product
    Morphine 40 mg/ml + Clonidine 500 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1770-2015·2015-09-23

    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 (20/2.5/20) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1581-2015·2015-09-23

    Mitomycin Ophthalmic Solution Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Mitomycin 0.02% Ophthalmic Solution due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Mitomycin 0.02% Ophthalmic Solution, single dose dropper, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1549-2015·2015-09-23

    Hydromorphone Solution Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Hydromorphone 30 mg/ml Solution due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Hydromorphone 30 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1448-2015·2015-09-23

    FDA Recalls Bupivacaine and Baclofen Intrathecal Solution Due to Sterility Concerns

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

    Product
    Bupivacaine 40 mg/ml +Baclofen 130 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1749-2015·2015-09-23

    Testosterone Pellets Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Testosterone 60 mg sterile pellets nationwide due to FDA inspection findings regarding sterility assurance.

    Product
    Testosterone 60 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1613-2015·2015-09-23

    Morphine and Bupivacaine Solution Recalled for Sterility Concerns

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

    Product
    Morphine 64 mg/ml + Bupivacaine 10 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1470-2015·2015-09-23

    Estradiol Pellets Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Estradiol 22 mg sterile pellets nationwide because FDA inspections found GMP violations that may affect sterility.

    Product
    Estradiol 22 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1659-2015·2015-09-23

    FDA Recalls Testosterone and Anastrazole Pellets Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Testosterone 200 mg Anastrazole 9 mg Pellets because an FDA inspection found GMP violations that may affect sterility.

    Product
    Testosterone 200 mg Anastrazole 9 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1525-2015·2015-09-23

    HCG Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling HCG 5,000 IU/ml injections due to FDA inspection findings regarding sterility assurance and GMP violations.

    Product
    HCG 5,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1504-2015·2015-09-23

    FDA Recalls HCG and Hydroxocobalamin Injection Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling HCG and Hydroxocobalamin injections because an FDA inspection found violations that may affect sterility.

    Product
    HCG 1,000 IU/ml + Hydroxocobalamin 1,000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide