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.

151–175 of 823

  • SevereFDA (Drugs)·D-1755-2015·2015-09-23

    Testosterone Cypionate Injection Recalled Due to Sterility Assurance Concerns

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

    Product
    Testosterone Cypionate 250 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1589-2015·2015-09-23

    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 regarding GMP violations and lack of sterility assurance.

    Product
    Morphine 20 mg/ml + Clonidine 400 mcg/ml 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-1780-2015·2015-09-23

    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 (30/1/22) Injectable, 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-1612-2015·2015-09-23

    Morphine Solution Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Morphine 60 mg/ml Solution due to FDA inspection findings regarding sterility and GMP violations.

    Product
    Morphine 60 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1468-2015·2015-09-23

    Estradiol Pellets Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Estradiol 18 mg sterile pellets due to GMP violations that may impact sterility.

    Product
    Estradiol 18 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1795-2015·2015-09-23

    FDA Recalls Tri-Mix Injectable Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Tri-Mix Injectable nationwide because an FDA inspection found GMP violations that may affect sterility.

    Product
    Tri-Mix ST3/PGE 2/LIDO 2 0.06/0.2/0.02 Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1758-2015·2015-09-23

    Testosterone Cypionate Injection Recalled Due to Sterility Concerns

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

    Product
    Testosterone Cypionate 250 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1630-2015·2015-09-23

    Sermorelin/GHRP2 Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Sermorelin/GHRP2 Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Sermorelin/GHRP2 1000/1000 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-1812-2015·2015-09-23

    FDA Recalls Tri-Mix Injectable Due to Sterility Concerns

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

    Product
    Tri-Mix T-50/PGE 2/LIDO 2 0.09/0.32/0.04 Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1722-2015·2015-09-23

    Tri-Mix Injectable Recalled for Potential Sterility Issues

    The Compounding Pharmacy of America is recalling Tri-Mix injectable vials because FDA inspections found GMP violations that may affect sterility.

    Product
    Tri-Mix (15 mg/0.5 mg/20 mcg) Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1434-2015·2015-09-23

    Acetyl-L-Carnitine Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Acetyl-L-Carnitine 500 mg/ml injectable vials because an FDA inspection identified GMP violations that may impact sterility.

    Product
    Acetyl-L-Carnitine 500 mg/ml, Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1509-2015·2015-09-23

    Compounded 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 1,100 IU/ml + Methylcobalamin 0.5 mg/ml Injection, ml Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1733-2015·2015-09-23

    LipoLean Injectable Recalled Due to Sterility Assurance Concerns

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

    Product
    LIPOLEAN Injectable, Multi-Dose Vial, Sterile, Room Temperature, 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-1623-2015·2015-09-23

    Phosphatidylcholine Injection Recalled for Sterility Assurance Concerns

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

    Product
    Phosphatidylcholine 0.1% Sodium Deoxycholate 0.089% Injection, Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1526-2015·2015-09-23

    HCG Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling HCG 1,500 IU/ml Injection vials because an FDA inspection found GMP violations that may impact sterility.

    Product
    HCG 1,500 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate 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-1502-2015·2015-09-23

    Folic Acid Injection Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Folic Acid 5 mg/ml Injection due to FDA inspection findings of GMP violations impacting sterility.

    Product
    Folic Acid 5 mg/ml 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-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-1646-2015·2015-09-23

    FDA Recalls Compounded Injectable Testosterone and Anastrazole Vials for Sterility Concerns

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

    Product
    Testosterone Cypionate 200 mg/ml Anastrazole 0.25 mg/ml Cholecalciferol 50,000 U/ml, Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1674-2015·2015-09-23

    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 impact sterility.

    Product
    Hydromorphone 45 mg/ml + Fentanyl 10,000 mcg/ml + Bupivacaine 15 mg/ml + Baclofen 720 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1666-2015·2015-09-23

    Bi-Mix Medium Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Bi-Mix Medium (30/1) Injectable due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Bi-Mix Medium (30/1) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide