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.

1676–1700 of 2384

  • SevereFDA (Drugs)·D-1500-2015·2015-09-23

    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 7,500 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-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-1518-2015·2015-09-23

    HCG Injection Recalled for Potential Sterility Issues

    The Compounding Pharmacy of America is recalling HCG 1,000 IU/ml Injection vials due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    HCG 1,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1458-2015·2015-09-23

    Cyanocobalamin Pellets Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Cyanocobalamin 10 mg Pellets because an FDA inspection found GMP violations that may impact sterility.

    Product
    Cyanocobalamin 10 mg Pellet, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1503-2015·2015-09-23

    Glutathione Injection Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling Glutathione 200 mg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Glutathione 200 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1511-2015·2015-09-23

    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 2,500 IU/ml + Methylcobalamin 500 mcg/ml, Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1587-2015·2015-09-23

    Morphine Solution Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling Morphine 15 mg/ml Solution due to FDA inspection findings of GMP violations that impact sterility.

    Product
    Morphine 15 mg/ml Solution, Sterile-Preservative Free, 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-1600-2015·2015-09-23

    FDA Recalls Morphine and Bupivacaine Solution Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Morphine and Bupivacaine solution because FDA inspections found violations that may affect sterility.

    Product
    Morphine 40 mg/ml + Bupivacaine 16 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1724-2015·2015-09-23

    Vitatrim Active Injectable Recalled for Sterility Assurance Concerns

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

    Product
    Vitatrim Active Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1792-2015·2015-09-23

    Tri-Mix ST1 Injectable Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Tri-Mix ST1 Injectable due to GMP violations identified by FDA that may impact sterility.

    Product
    Tri-Mix ST1 (30 mg/1.5 mg/50 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1456-2015·2015-09-23

    Copper Sulfate Injectable Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Copper Sulfate 2 mg/ml Injectable due to GMP violations that may impact sterility.

    Product
    Copper (Cupric)Sulfate 2 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1447-2015·2015-09-23

    Brompheniramine Maleate Injectable Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Brompheniramine Maleate 20 mg/ml Injectable due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Brompheniramine Maleate 20 mg/ml Injectable, Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1708-2015·2015-09-23

    FDA Recalls Compounded Sterile Pain Medication Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling a compounded sterile solution containing morphine, fentanyl, bupivacaine, and clonidine due to GMP violations affecting sterility.

    Product
    Morphine 50 mg/ml + Fentanyl 2,000 mcg/ml + Bupivacaine 10 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-1714-2015·2015-09-23

    Myers Cocktail Injection Recalled Due to Sterility Assurance Concerns

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

    Product
    Myers Cocktail Injection, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1715-2015·2015-09-23

    MYO-DEN Injection Recalled Due to Sterility Assurance Concerns

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

    Product
    MYO-DEN Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1588-2015·2015-09-23

    Morphine Solution Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Morphine 20 mg/ml Solution because FDA inspections found GMP violations that may impact sterility.

    Product
    Morphine 20 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1493-2015·2015-09-23

    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 2,000 mcg/ml + Bupivacaine 30 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1620-2015·2015-09-23

    Compounded Alprostadil Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling PGE 150 (Alprostadil) due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    PGE 150 (Alprostadil) 150 mcg/ml, ml, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1431-2015·2015-09-23

    5-MTHF Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling 5-MTHF injectable vials because FDA inspections found GMP violations that may affect sterility.

    Product
    5-Methyl Tetrahydrofolate (5-MTHF) 1 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1689-2015·2015-09-23

    Compounding Pharmacy Recalls LIPO-VITE III Injection Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling LIPO-VITE III Injection because an FDA inspection found GMP violations that may impact sterility.

    Product
    LIPO-VITE III, Injection Multi-Dose Vial, Sterile, Room Temperature, 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
  • SevereFDA (Drugs)·D-1575-2015·2015-09-23

    FDA Recalls Methylcobalamin and Hydroxocobalamin Injectable Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Methylcobalamin and Hydroxocobalamin Injectable due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Methylcobalamin 1,000 mcg/ml + Hydroxocobalamin 1,000 mcg/ml Injectable, Preservative Free, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1618-2015·2015-09-23

    FDA Recalls Neomycin Ophthalmic Ointment Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Neomycin + Polymyxin B + Bacitracin Ophthalmic Ointment because FDA inspections found GMP violations that may affect sterility.

    Product
    Neomycin + Polymyxin B+ Bacitracin Ophthalmic Ointment, grams, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1789-2015·2015-09-23

    Tri-Mix Injectable Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Tri-Mix AT-6 Injectable due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Tri-Mix AT-6 (60 mg/4 mg/0.3 mg) Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide