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.

126–150 of 823

  • SevereFDA (Drugs)·D-1744-2015·2015-09-23

    Testosterone Pellets Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Testosterone 20 mg sterile pellets due to GMP violations that may impact sterility.

    Product
    Testosterone 20 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1653-2015·2015-09-23

    FDA Recalls Testosterone Pellets Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Testosterone 70 mg Pellets because an FDA inspection found GMP violations that may affect sterility.

    Product
    Testosterone 70 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1749-2015·2015-09-23

    Testosterone Pellets Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Testosterone 60 mg sterile pellets nationwide due to FDA inspection findings regarding sterility assurance.

    Product
    Testosterone 60 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1690-2015·2015-09-23

    Lipotropic Injection Recalled for Sterility Assurance Concerns

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

    Product
    Lipotropic (w/Cyanocobalamin 4000 mcg/ml) Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1807-2015·2015-09-23

    Tri-Mix Injectable Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling Tri-Mix T-106 Injectable due to FDA inspection findings of GMP violations that impact sterility.

    Product
    Tri-Mix T-106 (30 mg/1 mg/25 mcg) Injectable,The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1571-2015·2015-09-23

    Methylcobalamin Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Methylcobalamin 4,000 mcg/ml Injectable vials because FDA inspections found GMP violations that may impact sterility.

    Product
    Methylcobalamin 4,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1656-2015·2015-09-23

    Testosterone Pellets Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Testosterone 80 mg Pellets because FDA inspections found GMP violations that may impact sterility.

    Product
    Testosterone 80 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1535-2015·2015-09-23

    Hyaluronic Acid Injection Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Hyaluronic Acid Sodium and Lidocaine HCl Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Hyaluronic Acid Sodium 32 mg/ml + Lidocaine HCl 3 mg/ml Injection, ml Syringe, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1617-2015·2015-09-23

    Nandrolone Decanoate Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Nandrolone Decanoate 250 mg/ml injections due to FDA-identified GMP violations that may impact sterility.

    Product
    Nandrolone Decanoate 250 mg/ml Injection, ml Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1649-2015·2015-09-23

    Testosterone Propionate Injection Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Testosterone Propionate 100 mg/ml Injection due to FDA inspection findings regarding sterility assurance.

    Product
    Testosterone Propionate 100 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1570-2015·2015-09-23

    Methylcobalamin Injectable Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling Methylcobalamin 10,000 mcg/ml Injectable due to GMP violations that may impact sterility.

    Product
    Methylcobalamin 10,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, 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-1766-2015·2015-09-23

    Compounded Tri-Mix Injectable Recalled for Sterility Assurance Concerns

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

    Product
    Tri-Mix (17.7/0.59/6) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1773-2015·2015-09-23

    FDA Recalls Tri-Mix Injectable Due to Sterility Concerns

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

    Product
    Tri-Mix (25/2.5/10) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1702-2015·2015-09-23

    FDA Recalls Morphine and Bupivacaine Compounded Solution Due to Sterility Concerns

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

    Product
    Morphine 25 mg/ml + Bupivacaine 30 mg/ml + Clonidine 200 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1707-2015·2015-09-23

    FDA Recalls Compounded Sterile Morphine, Fentanyl, and Bupivacaine Solution

    The Compounding Pharmacy of America is recalling a sterile compounded solution of morphine, fentanyl, and bupivacaine due to GMP violations that compromise sterility assurance.

    Product
    Morphine 50 mg/ml + Fentanyl 10,000 mcg/ml + Bupivacaine 25 mg/ml, Solution, Sterile, Preservative Free, 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-1557-2015·2015-09-23

    Hydroxocobalamin Injection Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Hydroxocobalamin 10,000 mcg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Hydroxocobalamin 10,000 mcg/ml Injection, Multi-Dose Vial, sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1752-2015·2015-09-23

    Compounded Testosterone and Estradiol Injection Recalled for Sterility Concerns

    The Compounding Pharmacy of America is recalling Testosterone Bi-Blend and Estradiol Valerate injections due to FDA inspection findings regarding sterility assurance.

    Product
    Testosterone Bi-Blend 15 mg/ml +Estradiol Valerate 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-1695-2015·2015-09-23

    Compounded Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Lipovicine-Choline and Ascorbic Acid injectable vials because an FDA inspection identified GMP violations that may impact sterility.

    Product
    Lipovicine-Choline 100 mg/ml-Acorbic Acid 45 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1783-2015·2015-09-23

    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 (30/2/20) (MFG) Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1486-2015·2015-09-23

    FDA Recalls Fentanyl Intrathecal Solution Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Fentanyl 7,000 mcg/ml + Bupivacaine 6 mg/ml + Clonidine 40 mcg/ml Intrathecal Solution due to GMP violations affecting sterility.

    Product
    Fentanyl 7,000 mcg/ml + Bupivacaine 6 mg/ml + Clonidine 40 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1569-2015·2015-09-23

    Methylcobalamin Injectable Recalled for Sterility Assurance Concerns

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

    Product
    Methylcobalamin 1,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1581-2015·2015-09-23

    Mitomycin Ophthalmic Solution Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Mitomycin 0.02% Ophthalmic Solution due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Mitomycin 0.02% Ophthalmic Solution, single dose dropper, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1433-2015·2015-09-23

    FDA Recalls Acetyl-L-Carnitine Injectable Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Acetyl-L-Carnitine 250 mg/ml Injectable vials because FDA inspections identified GMP violations that may impact sterility.

    Product
    Acetyl-L-Carnitine 250 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide