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.

326–350 of 823

  • SevereFDA (Drugs)·D-1673-2015·2015-09-23

    Hydromorphone and Bupivacaine Intrathecal Solution Recalled for Sterility Concerns

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

    Product
    Hydromorphone 35 mg/ml + Bupivacaine 4 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1614-2015·2015-09-23

    FDA Recalls Morphine and Bupivacaine Solution Due to Sterility Concerns

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

    Product
    Morphine 70 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-1637-2015·2015-09-23

    Sufentanil Solution Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Sufentanil 50 mcg/ml Solution due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Sufentanil 50 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1736-2015·2015-09-23

    Morphine Solution Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Morphine 30 mg/ml Solution because an FDA inspection found GMP violations that may affect sterility.

    Product
    Morphine 30 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-1738-2015·2015-09-23

    FDA Recalls Morphine and Bupivacaine Solution Due to Sterility Concerns

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

    Product
    Morphine 40 mg/ml + Bupivacaine 16 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1728-2015·2015-09-23

    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 40 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1784-2015·2015-09-23

    Tri-Mix Injectable Recalled for Lack of Sterility Assurance

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

    Product
    Tri-Mix (37.5 mg/1.5 mg/50 mcg) Injectable, 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-1706-2015·2015-09-23

    FDA Recalls Compounded Morphine and Fentanyl Solution Due to Sterility Concerns

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

    Product
    Morphine 50 mg/ml + Fentanyl 1,500 mcg/ml + Baclofen 800 mcg/ml +Clonidine 200 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1748-2015·2015-09-23

    Testosterone Sterile Pellets Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling Testosterone 37.5 mg sterile pellets due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Testosterone 37.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-1729-2015·2015-09-23

    FDA Recalls Compounded Intrathecal Pain Solution Due to Sterility Concerns

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

    Product
    Hydromorphone 70 mg/ml+Fentanyl 16,000 mcg/ml+Bupivacaine 15 mg/ml+Clonidine 1,000 mcg/ml+Baclofen 900 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1714-2015·2015-09-23

    Myers Cocktail Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Myers Cocktail Injection due to FDA inspection findings regarding GMP violations and lack of sterility assurance.

    Product
    Myers Cocktail Injection, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1793-2015·2015-09-23

    FDA Recalls Tri-Mix ST2 Injectable Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Tri-Mix ST2 Injectable nationwide due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Tri-Mix ST2 (30 mg/3 mg/100 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1487-2015·2015-09-23

    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 8,000 mcg/ml + Bupivacaine 30 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1469-2015·2015-09-23

    Estradiol Pellets Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Estradiol 20 mg sterile pellets nationwide because FDA inspections identified GMP violations that may impact sterility.

    Product
    Estradiol 20 mg, Sterile Pellet, 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-1622-2015·2015-09-23

    Alprostadil Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling PGE 80 (Alprostadil) 80 mcg/ml Injection because an FDA inspection identified GMP violations that may impact sterility.

    Product
    PGE 80 (Alprostadil) 80 mcg/ml Injection, Multi-Dose Vial, Sterile, Keep Frozen, 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-1546-2015·2015-09-23

    FDA Recalls Hydromorphone Solution Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Hydromorphone 15 mg/ml Solution because FDA inspections found violations that may affect sterility.

    Product
    Hydromorphone 15 mg/ml 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-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-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-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