The Recall Desk

Hazard

Gmp Violation recalls

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

What the numbers show

Total
823
Critical
49
Severe
376
Most recent
2026-03-04

Of the 823 gmp violation recalls we have scored against our rubric, 49 (6%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 376 (46%) 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 violation 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.

101–125 of 823

  • SevereFDA (Drugs)·D-1642-2015·2015-09-23

    Testosterone Cypionate Injection Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Testosterone Cypionate 200mg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Testosterone Cypionate 200mg/ml Injection Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1436-2015·2015-09-23

    Alprostadil Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Alprostadil 10 mcg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Alprostadil 10 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1777-2015·2015-09-23

    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 (30/1/10) (MFG) Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-1595-2015·2015-09-23

    Morphine and Clonidine Solution Recalled for Sterility Assurance Concerns

    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 30 mg/ml + Clonidine 250 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1655-2015·2015-09-23

    Testosterone Pellets Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling Testosterone 75 mg Pellets due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Testosterone 75 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1644-2015·2015-09-23

    FDA Recalls Testosterone Cypionate and Anastrazole Injection Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Testosterone Cypionate and Anastrazole Injection because FDA inspections found GMP violations that may affect sterility.

    Product
    Testosterone Cypionate 200 mg/ml Anastrazole 0.5 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1676-2015·2015-09-23

    FDA Recalls Compounded Hydromorphone Fentanyl Bupivacaine Intrathecal Solution

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

    Product
    Hydromorphone 60 mg/ml + Fentanyl 1,000 mcg/ml + Bupivacaine 10 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1810-2015·2015-09-23

    Tri-Mix Injectable Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Tri-Mix T-50/PGE 1 0.14/0.08 Injectable due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Tri-Mix T-50/PGE 1 0.14/0.08 Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1711-2015·2015-09-23

    FDA Recalls Morphine and Ropivacaine Compounded Solution Due to Sterility Concerns

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

    Product
    Morphine 50 mg/ml + Ropivacaine 5 mg/ml +Baclofen 20 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1477-2015·2015-09-23

    Estradiol Cypionate Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Estradiol Cypionate 5mg/ml injectable vials because FDA inspections identified GMP violations that may impact product sterility.

    Product
    Estradiol Cypionate 5mg/ml Injectable, ml Multi-Dose Vial, Sterile Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1552-2015·2015-09-23

    Hydromorphone Solution Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Hydromorphone 5 mg/ml Solution because FDA inspections found GMP violations that may affect sterility.

    Product
    Hydromorphone 5 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1604-2015·2015-09-23

    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 that may impact sterility.

    Product
    Morphine 42 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-1467-2015·2015-09-23

    Estradiol Pellets Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Estradiol 15 mg sterile pellets nationwide because FDA inspections identified GMP violations affecting sterility.

    Product
    Estradiol 15 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1658-2015·2015-09-23

    Testosterone and Anastrazole Pellets Recalled for Sterility Concerns

    The Compounding Pharmacy of America is recalling Testosterone 200 mg Anastrazole 1 mg Pellets due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Testosterone 200 mg Anastrazole 1 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1556-2015·2015-09-23

    Hydroxocobalamin Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Hydroxocobalamin 1,000 mcg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Hydroxocobalamin 1,000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1606-2015·2015-09-23

    Morphine and Bupivacaine Solution Recalled for Sterility Assurance Concerns

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

    Product
    Morphine 45 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-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-1800-2015·2015-09-23

    FDA Recalls Tri-Mix Injectable Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Tri-Mix ST9C Injectable nationwide due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Tri-Mix ST9C (30 mg/2 mg/120 mcg) Injectable, 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-1629-2015·2015-09-23

    Sermorelin Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Sermorelin 1000 mcg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Sermorelin 1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1590-2015·2015-09-23

    Morphine and Clonidine Solution Recalled for Sterility Assurance Concerns

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

    Product
    Morphine 20 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-1563-2015·2015-09-23

    Lidocaine and Epinephrine Vials Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Lidocaine 2% with Epinephrine 1:100,000 vials due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Lidocaine 2% with Epinephrine 1:100,000 (Buffered) Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1700-2015·2015-09-23

    Compounded MEGA-BURN Injection Recalled for Sterility Assurance Concerns

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

    Product
    MEGA-BURN* Injection, Multi-Dose Vial, Sterile, Room Temperature, 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