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.

1601–1625 of 2384

  • SevereFDA (Drugs)·D-1734-2015·2015-09-23

    Compounded Injectable Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling LIPOLEAN + Ascorbic Acid injectable vials due to FDA inspection findings of GMP violations that impact sterility.

    Product
    LIPOLEAN + Ascorbic Acid 50 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1567-2015·2015-09-23

    FDA Recalls Compounded Injectable Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Methionine, Inositol, and Choline injectable vials because FDA inspections found GMP violations that may impact sterility.

    Product
    Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 25 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1685-2015·2015-09-23

    Compounded Lipoderm Injection Recalled for Sterility Assurance Concerns

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

    Product
    LIPO-DEN MODIFIED Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1624-2015·2015-09-23

    Polidocanol Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Polidocanol 1% Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Polidocanol 1% Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1677-2015·2015-09-23

    FDA Recalls Compounded Intrathecal Solution Due to Sterility Concerns

    The FDA is recalling a compounded intrathecal solution from The Compounding Pharmacy of America due to GMP violations that may impact sterility.

    Product
    Hydromorphone 60 mg/ml + Fentanyl 20,000 mcg/ml + Bupivacaine 40 mg/ml + Clonidine 1,000 mcg/ml + Baclofen 300 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1482-2015·2015-09-23

    FDA Recalls Fentanyl and Bupivacaine Intrathecal Solution Due to Sterility Concerns

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

    Product
    Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml Clonidine 1,300 mcg/ml + Baclofen 300 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1668-2015·2015-09-23

    Calmme Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Calmme Injectable multi-dose vials because an FDA inspection identified GMP violations that may impact sterility.

    Product
    Calmme Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1548-2015·2015-09-23

    Hydromorphone and Bupivacaine Solution Recalled for Sterility Concerns

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

    Product
    Hydromorphone 20 mg/ml + Bupivacaine 0.25 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1645-2015·2015-09-23

    Testosterone Cypionate and Anastrazole Injection Recalled for Sterility Concerns

    The Compounding Pharmacy of America is recalling Testosterone Cypionate and Anastrazole Injection due to GMP violations that may affect sterility.

    Product
    Testosterone Cypionate 200 mg/ml Anastrazole 2 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1760-2015·2015-09-23

    Testosterone Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Testosterone Tri-Blend injections due to FDA inspection findings regarding sterility assurance and GMP violations.

    Product
    Testosterone Tri-Blend 200 mg/ml (10 ml Sesame Oil) Injection, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1657-2015·2015-09-23

    FDA Recalls Testosterone and Anastrazole Pellets Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Testosterone 60 mg Anastrazole 4 mg Pellets because an FDA inspection found GMP violations that may impact sterility.

    Product
    Testosterone 60 mg Anastrazole 4 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1533-2015·2015-09-23

    HCG Injection Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling HCG 500 IU/ml Injection vials because FDA inspections found GMP violations that may impact sterility.

    Product
    HCG 500 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1596-2015·2015-09-23

    Morphine Solution Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Morphine 33 mg/ml Solution due to FDA inspection findings regarding sterility assurance.

    Product
    Morphine 33 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1501-2015·2015-09-23

    Fentanyl and Bupivacaine Intrathecal Solution Recalled for Sterility Concerns

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

    Product
    Fentanyl 8,000 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-1611-2015·2015-09-23

    Morphine and Fentanyl Solution Recalled for Sterility Assurance Concerns

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

    Product
    Morphine 50 mg/ml +Fentanyl 1,000 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1506-2015·2015-09-23

    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 1,000 IU/ml + Methylcobalamin 0.5 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1731-2015·2015-09-23

    FDA Recalls Compounded Hydromorphone and Fentanyl Intrathecal Solution for Sterility Concerns

    The Compounding Pharmacy of America is recalling compounded intrathecal solutions due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Hydromorphone 80 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml Intrathecal Solution, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1453-2015·2015-09-23

    Cholecalciferol Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Cholecalciferol 600,000 IU/ml Injectable due to GMP violations that may impact sterility.

    Product
    Cholecalciferol 600,000 IU/ml Injectable, ml Vial, Sterile, Refrigerate, The Compounding Pharmac of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1519-2015·2015-09-23

    HCG Injection Recalled Due to Lack of Assurance of Sterility

    The Compounding Pharmacy of America is recalling HCG 1,100 IU/ml Injection vials because FDA inspections found GMP violations that may impact sterility.

    Product
    HCG 1,100 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1768-2015·2015-09-23

    FDA Recalls Tri-Mix Injectable Due to Sterility Assurance Concerns

    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 (18/0.6/5.88) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1692-2015·2015-09-23

    Lipotropic B-12 Injection Recalled for Sterility Assurance Issues

    The Compounding Pharmacy of America is recalling Lipotropic B-12 II + Lidocaine Injection due to FDA inspection findings of GMP violations that impact sterility.

    Product
    Lipotropic B-12 II* + Lidocaine Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1462-2015·2015-09-23

    Dexpanthenol Injectable Recalled for Sterility Assurance Concerns

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

    Product
    Dexpanthenol 250 mg/ml Injectable, ml Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1540-2015·2015-09-23

    FDA Recalls Hydromorphone Intrathecal Solution Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Hydromorphone 0.25 mg/ml Intrathecal Solution because an FDA inspection found GMP violations that may affect sterility.

    Product
    Hydromorphone 0.25 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1802-2015·2015-09-23

    Tri-Mix SUPER Injectable Recalled for Sterility Assurance Concerns

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

    Product
    Tri-Mix SUPER (28 mg/0.9 mg/37 mcg) Injectable, Sterile Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1544-2015·2015-09-23

    FDA Recalls Hydromorphone and Bupivacaine Solution Due to Sterility Concerns

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

    Product
    Hydromorphone 10 mg/ml + Bupivacaine 10 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide