The Recall Desk

Hazard

Gmp Violations recalls

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

What the numbers show

Total
58
Critical
0
Severe
57
Most recent
2015-09-23

Of the 58 gmp violations recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 57 (98%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all gmp violations 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.

26–50 of 58

  • SevereFDA (Drugs)·D-1618-2015·2015-09-23

    FDA Recalls Neomycin Ophthalmic Ointment Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Neomycin + Polymyxin B + Bacitracin Ophthalmic Ointment because FDA inspections found GMP violations that may affect sterility.

    Product
    Neomycin + Polymyxin B+ Bacitracin Ophthalmic Ointment, grams, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1740-2015·2015-09-23

    Alprostadil Injection Recalled for Potential Sterility Issues

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

    Product
    PGE 2 (Alprostadil) 100 mcg/ml, Sterile, Keep Frozen, 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-1805-2015·2015-09-23

    FDA Recalls Tri-Mix Injectable Due to Sterility Concerns

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

    Product
    Tri-Mix T-102/PGE 2/LIDO 2 0.06/0.3/0.2 Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1664-2015·2015-09-23

    Bi-Mix #1 Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Bi-Mix #1 Injectable due to FDA inspection findings of GMP violations that impact sterility assurance.

    Product
    Bi-Mix #1 (17.365 mg/0.59 mg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1575-2015·2015-09-23

    FDA Recalls Methylcobalamin and Hydroxocobalamin Injectable Due to Sterility Concerns

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

    Product
    Methylcobalamin 1,000 mcg/ml + Hydroxocobalamin 1,000 mcg/ml Injectable, Preservative Free, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1806-2015·2015-09-23

    FDA Recalls Tri-Mix Injectable Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Tri-Mix T-105 Injectable due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Tri-Mix T-105 (30 mg/1 mg/10 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1492-2015·2015-09-23

    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 2,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1463-2015·2015-09-23

    DMPS Injectable Recalled for Lack of Sterility Assurance

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

    Product
    DMPS (Sodium 2, 3 Dimercaptopropane Sulfonate) 50 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1444-2015·2015-09-23

    B-Complex Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling B-Complex Injection nationwide because FDA inspections found GMP violations that may affect sterility.

    Product
    B-Complex Injection, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1593-2015·2015-09-23

    Morphine and Baclofen Solution Recalled Due to Sterility Concerns

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

    Product
    Morphine 30 mg/ml + Baclofen 10 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1472-2015·2015-09-23

    Estradiol Pellets Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling Estradiol 3 mg sterile pellets due to GMP violations that may impact sterility.

    Product
    Estradiol 3 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., 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-1608-2015·2015-09-23

    Morphine and Bupivacaine Solution Recalled for Sterility Concerns

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

    Product
    Morphine 50 mg/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-1665-2015·2015-09-23

    Bi-Mix Injectable Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling Bi-Mix (20/1) Injectable due to FDA inspection findings of GMP violations that impact sterility.

    Product
    Bi-Mix (20/1) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1543-2015·2015-09-23

    FDA Recalls Hydromorphone and Baclofen Intrathecal Solution Due to Sterility Concerns

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

    Product
    Hydromorphone 10 mg/ml + Baclofen 2,500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1723-2015·2015-09-23

    Vitatrim Injection Recalled Due to Sterility Assurance Concerns

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

    Product
    Vitatrim Injection, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1505-2015·2015-09-23

    FDA Recalls HCG and Methylcobalamin Injection Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling HCG and Methylcobalamin injections nationwide because FDA inspections found violations that may have compromised product sterility.

    Product
    HCG 1,000 IU/ml + Methylcobalamin 0.05 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1550-2015·2015-09-23

    Hydromorphone and Bupivacaine Solution Recalled for Sterility Assurance Concerns

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

    Product
    Hydromorphone 40 mg/ml + Bupivacaine 20 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1703-2015·2015-09-23

    FDA Recalls Morphine and Bupivacaine Compounded Solution Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling a sterile morphine and bupivacaine solution because FDA inspections found violations that may affect sterility.

    Product
    Morphine 45 mg/ml + Bupivacaine 8 mg/ml + Baclofen 25 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-1698-2015·2015-09-23

    FDA Recalls MEGA-BURN IV Injectable Due to Sterility Concerns

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

    Product
    MEGA-BURN IV Injectable, 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-1746-2015·2015-09-23

    Testosterone Sterile Pellets Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Testosterone 25 mg sterile pellets due to GMP violations that may impact sterility.

    Product
    Testosterone 25 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1601-2015·2015-09-23

    FDA Recalls Morphine and Bupivacaine Solution Due to Sterility Concerns

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