The Recall Desk

Hazard

Sterility recalls

2,384 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,384
Critical
1
Severe
2,114
Most recent
2026-09-09

Of the 2,384 sterility recalls we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,114 (89%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterility 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.

1651–1675 of 2384

  • SevereFDA (Drugs)·D-1775-2015·2015-09-23

    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 (30/0.5/10) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1757-2015·2015-09-23

    Testosterone Cypionate Injection Recalled Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Testosterone Cypionate 40 mg/ml injections due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Testosterone Cypionate 40 mg/ml (10 ml Sesame Oil), Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1485-2015·2015-09-23

    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 4,000 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-1599-2015·2015-09-23

    Morphine Solution Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Morphine 40 mg/ml Solution due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Morphine 40 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1534-2015·2015-09-23

    FDA Recalls Compounded Hyaluronic Acid Injection Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Hyaluronic Acid Sodium and Lidocaine HCl Injection because an FDA inspection found GMP violations that may affect sterility.

    Product
    Hyaluronic Acid Sodium 28 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-1675-2015·2015-09-23

    FDA Recalls Hydromorphone and Fentanyl Intrathecal Solution Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Hydromorphone, Fentanyl, and Bupivacaine Intrathecal Solution because FDA inspections found GMP violations that may affect sterility.

    Product
    Hydromorphone 50 mg/ml + Fentanyl 3,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1778-2015·2015-09-23

    Tri-Mix Injectable Recalled for 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 (30/1/20) Injectable, 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-1718-2015·2015-09-23

    Quad-Mix 4 Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Quad-Mix 4 Injectable vials because FDA inspections found GMP violations that may affect sterility.

    Product
    Quad-Mix 4 Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1811-2015·2015-09-23

    FDA Recalls Tri-Mix Injectable Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Tri-Mix T-50/PGE 2/LIDO 2 0.03/0.18/0.09 Injectable because an FDA inspection identified GMP violations that may impact sterility.

    Product
    Tri-Mix T-50/PGE 2/LIDO 2 0.03/0.18/0.09 Injectable, 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-1580-2015·2015-09-23

    Carnitine Injectable Recalled Due to Sterility Assurance Concerns

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

    Product
    MIC-PLUS Carnitine Injectable, Multi-Dose Vial, Sterile, Room Temperature, 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-1610-2015·2015-09-23

    FDA Recalls Morphine and Clonidine Solution Due to Sterility Concerns

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

    Product
    Morphine 50 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-1449-2015·2015-09-23

    Bupivacaine Intrathecal Solution Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Bupivacaine 15 mg/ml Intrathecal Solution due to FDA inspection findings regarding GMP violations and lack of sterility assurance.

    Product
    Bupivacaine 15 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1512-2015·2015-09-23

    HCG Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling HCG 1,000 IU/ml Injection kits because an FDA inspection identified GMP violations that may impact sterility.

    Product
    HCG 1,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 23 DAY KIT, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1764-2015·2015-09-23

    Tri-Mix Injectable Recalled for Potential Sterility Assurance Issues

    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 mg/0.59 mg/6 mcg) Injectable, Sterile, Keep Frozen, 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-1536-2015·2015-09-23

    FDA Recalls Hyaluronic Acid Injection Due to Sterility Concerns

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

    Product
    Hyaluronic Acid Sodium 35 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-1799-2015·2015-09-23

    Tri-Mix ST9A Injectable Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Tri-Mix ST9A Injectable due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Tri-Mix ST9A (30 mg/2 mg/80 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1716-2015·2015-09-23

    Quad-Mix 1 Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Quad-Mix 1 Injectable due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Quad-Mix 1 Injectable, Multi-Dose Vial, Sterile, Keep Frozen, 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-1664-2015·2015-09-23

    Bi-Mix #1 Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Bi-Mix #1 Injectable due to FDA inspection findings of GMP violations that impact sterility assurance.

    Product
    Bi-Mix #1 (17.365 mg/0.59 mg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1558-2015·2015-09-23

    Hydroxocobalamin Injection Recalled Due to Sterility Assurance Concerns

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

    Product
    Hydroxocobalamin 5,000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1591-2015·2015-09-23

    FDA Recalls Morphine and Baclofen Solution Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Morphine and Baclofen solution because an FDA inspection found violations that may affect sterility.

    Product
    Morphine 25 mg/ml + Baclofen 100 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide