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
377
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 377 (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-1514-2015·2015-09-23

    Compounded HCG Injection Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling HCG 625 IU/ml Injection kits due to FDA inspection findings regarding GMP violations and lack of sterility assurance.

    Product
    HCG 625 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 40 DAY KIT, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1464-2015·2015-09-23

    Estradiol Pellets Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling Estradiol 10 mg Sterile Pellets nationwide due to FDA inspection findings of GMP violations impacting sterility.

    Product
    Estradiol 10 mg Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1772-2015·2015-09-23

    Tri-Mix Injectable Recalled 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 (25/2.5/10) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1627-2015·2015-09-23

    Pyridoxine Hydrochloride Injectable Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Pyridoxine Hydrochloride 100 mg/ml Injectable due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Pyridoxine Hydrochloride 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, Protect from Light, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1597-2015·2015-09-23

    Morphine Solution Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Morphine 35 mg/ml Solution due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Morphine 35 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1607-2015·2015-09-23

    Morphine Solution Recalled Due to Sterility Assurance Concerns

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

    Product
    Morphine 50 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1495-2015·2015-09-23

    Fentanyl Intrathecal Solution Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Fentanyl 5,000 mcg/ml Intrathecal Solution due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Fentanyl 5,000 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1808-2015·2015-09-23

    FDA Recalls Tri-Mix Injectable Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Tri-Mix T-106/PGE 2 0.1/0.14 Injectable because an FDA inspection found GMP violations that may impact sterility.

    Product
    Tri-Mix T-106/PGE 2 0.1/0.14 Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1547-2015·2015-09-23

    Hydromorphone Solution Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Hydromorphone 20 mg/ml Solution due to FDA inspection findings regarding GMP violations and sterility assurance.

    Product
    Hydromorphone 20 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-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-1457-2015·2015-09-23

    Cyanocobalamin Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Cyanocobalamin 1,000 mcg/ml multi-dose vials because an FDA inspection identified GMP violations that may impact sterility.

    Product
    Cyanocobalamin 1,000 mcg/ml, Multi-Dose vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1461-2015·2015-09-23

    Dexpanthenol Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Dexpanthenol 215 mg/ml Injectable due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Dexpanthenol 215 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1479-2015·2015-09-23

    Estradiol Valerate Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Estradiol Valerate 40 mg/ml injectable vials because FDA inspections found GMP violations that may impact sterility.

    Product
    Estradiol Valerate 40 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, 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-1753-2015·2015-09-23

    FDA Recalls Testosterone and Estradiol Injectable Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Testosterone Bi-Blend and Estradiol Valerate injectable due to FDA inspection findings of GMP violations impacting sterility.

    Product
    Testosterone Bi-Blend 50 mg/ml + Estradiol Valerate 2.5 mg/ml Injectable, 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-1671-2015·2015-09-23

    FDA Recalls Hydromorphone and Baclofen Intrathecal Solution Due to Sterility Concerns

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

    Product
    Hydromorphone 3 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-1705-2015·2015-09-23

    FDA Recalls Morphine, Clonidine, and Baclofen Solution Due to Sterility Concerns

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

    Product
    Morphine 50 mg/ml + Clonidine 750 mcg/ml + Baclofen 15 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1523-2015·2015-09-23

    HCG Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling HCG 1,250 IU/ml Injection vials because FDA inspections identified GMP violations that may impact sterility.

    Product
    HCG 1,250 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy 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-1528-2015·2015-09-23

    HCG Injection Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling HCG 2,500 IU/ml Injection vials due to GMP violations that may impact sterility.

    Product
    HCG 2,500 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1779-2015·2015-09-23

    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 (30/1/20) (MFG) Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1605-2015·2015-09-23

    Morphine Solution Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Morphine 45 mg/ml Solution due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Morphine 45 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