The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

21851–21875 of 32121

  • 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-1632-2015·2015-09-23

    Sermorelin Injection Recalled for Lack of Sterility Assurance

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

    Product
    Sermorelin 1000mcg/GHRP6 1000/GHRP2 1000 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-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
  • 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-1538-2015·2015-09-23

    Hyaluronidase Injection Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling Hyaluronidase 150 units/ml Injection due to FDA inspection findings of GMP violations that impact sterility.

    Product
    Hyaluronidase 150 units/ml Injection, ml, Sterile, Preserved, Refrigerate, 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