The Recall Desk

Hazard

Sterility Failure recalls

1,691 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,691
Critical
12
Severe
931
Most recent
2026-07-29

Of the 1,691 sterility failure recalls we have scored against our rubric, 12 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 931 (55%) 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 failure 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.

1551–1575 of 1691

  • SevereFDA (Drugs)·D-581-2013·2013-06-12

    Pentec Health Recalls Proplete 34-39 KG Intradialytic Nutrition Bags

    Pentec Health is recalling Proplete 34-39 KG intradialytic parenteral nutrition bags because sterility could not be assured for the compounded sterile renal nutritional prescriptions.

    Product
    Proplete 34 - 39 KG (Intradialytic Parenteral Nutrition composed of amino acids, dextrose and sterile water), in 330mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-13132
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-595-2013·2013-06-12

    Pentec Health Recalls Baxter LL Bag 2% Amino Acids Due to Sterility Concerns

    Pentec Health is recalling Baxter LL bag 2% Amino Acids because sterility could not be assured for the compounded sterile renal nutritional prescriptions.

    Product
    Baxter LL bag 2% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 2500mL bag and b) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-585-2013·2013-06-12

    Pentec Health Recalls Intradialytic Parenteral Nutrition Bags Due to Sterility Concerns

    Pentec Health is recalling specific lots of IDPN dialysate solution bags because sterility could not be assured. The products were distributed to dialysis centers and directly to patients.

    Product
    IDPN (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), a) 490mL bag, b) 500mL bag, and c) 590mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-1505-2013·2013-06-12

    American Optisurgical Recalls ChloraPrep Applicators Due to Seal Defect

    American Optisurgical is recalling ChloraPrep Hi-Lite Orange 3mL Applicators because an incomplete seal on the packaging may have compromised sterility assurance.

    Product
    FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-481-2013·2013-06-05

    Nora Apothecary Recalls Hydroxycobalamin Injections Due to Sterility Concerns

    Nora Apothecary is recalling Hydroxycobalamin Injections because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Hydroxycobalamin Inj 1 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-479-2013·2013-06-05

    Nora Apothecary Recalls HCG Injections Due to Sterility Concerns

    Nora Apothecary and Alternative Therapies, Inc. is recalling HCG Inj 500un/ml MDV, 5 ml Subcutaneous due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    HCG Inj 500un/ml MDV, 5 ml Subcutaneous, 30 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-474-2013·2013-06-05

    Nora Apothecary Recalls PHMB Ophthalmic Solution Due to Sterility Concerns

    Nora Apothecary is recalling PHMB Ophthalmic Solution 0.02% because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    PHMB Opth Soln 0.02%, 10 ml Opthalmic Soln, 30 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-345-2013·2013-05-22

    Green Valley Drugs Recalls B-Complex Injections Due to Sterility Concerns

    Green Valley Drugs is recalling 679 vials of B-Complex Injection products nationwide due to a lack of assurance of sterility and quality control concerns.

    Product
    B-Complex Injection, all strengths and all presentations including a) B-Complex Injection 30 mL; b) B-Complex PF 2 mL; c) B-Complex Plus-100; d) B-Complex_B12_30 mL; e) B-Complex-50-Methyl-30-Lido 30 mL; f) B-CompSuper-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-339-2013·2013-05-22

    FDA Recalls Acetylcysteine Injection Due to Sterility Assurance Concerns

    Green Valley Drugs is recalling Acetylcysteine Injection vials because the pharmacy could not ensure the products were sterile.

    Product
    Acetylcysteine Injection, all strengths and all presentations including 100 mg/mL in 30 mL vials and 200 mg/mL in 30 mL and 50 mL vials, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-343-2013·2013-05-22

    Green Valley Drugs Recalls Betamethasone Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Betamethasone Acetate and Betamethasone Sodium Injection because the pharmacy lacked assurance of sterility in its quality control processes.

    Product
    Betamethasone Acetate and Betamethasone Sodium Injection, all strengths and all presentations including 6 mg/mL preservative free, 2 ml; 106 mg/mL 10 mL, and 6 mg/mL 5 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-351-2013·2013-05-22

    Green Valley Drugs Recalls Bupivacaine and Dexamethasone Injection for Sterility Concerns

    Green Valley Drugs is recalling Bupivacaine and Dexamethasone Injection due to a lack of assurance of sterility in its compounding and quality control processes.

    Product
    Bupivacaine and Dexamethasone Injection, all strengths and all presentations including Bupiv_Dexameth-0.25-10.5; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-357-2013·2013-05-22

    Green Valley Drugs Recalls Dexamethasone Sodium Phosphate Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Dexamethasone Sodium Phosphate Injection because the compounding pharmacy could not ensure the sterility of the products.

    Product
    Dexamethasone Sodium Phosphate Injection, all strengths and all presentations including a) Dexamethasone Sodium Phosphate 10 mg/1 mL, b) Dexamethasone Sodium Phosphate 10 mg/mL PF 1 mL, c) Dexamethasone Sodium Phosphate 4 mg/30 mL, d) Dexamethasone-4 mg/5 mL P.F., Rx only, Green
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-373-2013·2013-05-22

    Green Valley Drugs Recalls Hydrogen Peroxide Injection Due to Sterility Concerns

    FVS Holdings, Inc. dba. Green Valley Drugs is recalling Hydrogen Peroxide Injection due to a lack of assurance of sterility in compounded and repackaged products.

    Product
    Hydrogen Peroxide Injection, all strengths and all presentations including Hydrogen Peroxide 3% 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-342-2013·2013-05-22

    Green Valley Drugs Recalls Ascorbic Acid Injection Due to Sterility Concerns

    Green Valley Drugs is recalling 2,682 vials of Ascorbic Acid Injection nationwide due to a lack of assurance of sterility and quality control concerns.

    Product
    Ascorbic Acid Injection, all strengths and all presentations including a) 500 mg/mL, b) corn source 500 mg/mL, c) tapioca 500 mg/mL, d) cassave 500; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-395-2013·2013-05-22

    Green Valley Drugs Recalls MIC Vitamin Injections Due to Sterility Concerns

    Green Valley Drugs is recalling 588 vials and syringes of MIC Vitamin Injection nationwide due to a lack of assurance of sterility in its compounding and quality control processes.

    Product
    MIC Vitamin Injection, all strengths and all presentations including a) MIC 25-50-25-30 mL, b) MIC_B_COMP-B12-25-50-50-1000-30 mL, c) MIC_B12-25-50-25-400-30 mL, d) MIC_B6_B12-30 mL, e) MIC_METH_VIT-#3-30 m, f) MIC_METH-25-50-50-1000 mcg 30 mL, g) MIC_ULTRA-30 mL, h) MIC_VIT_METH
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-375-2013·2013-05-22

    Green Valley Drugs Recalls Hydroxyprogesterone Caproate Injection Due to Sterility Concerns

    FVS Holdings, Inc. dba. Green Valley Drugs is recalling 229 vials of Hydroxyprogesterone Caproate Injection nationwide due to lack of assurance of sterility.

    Product
    Hydroxyprogesterone Caproate Injection, all strengths and all presentations including Hydroxyprogesterone Caproate 250 mg/mL 1 mL, 4 mL, 5 mL, 10 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-402-2013·2013-05-22

    FDA Recalls Green Valley Drugs Progesterone Injection for Sterility Concerns

    Green Valley Drugs is recalling all Progesterone Injection products due to a lack of assurance of sterility and quality control concerns.

    Product
    Progesterone Injection, all strengths and all presentations including a) Progesterone 100 mg/mL 10 mL, 30 mL b) Progesterone 50 mg/mL 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-344-2013·2013-05-22

    Green Valley Drugs Recalls Bacteriostatic Water for Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Bacteriostatic Water for Injection because the company cannot ensure the products are sterile.

    Product
    Bacteriostatic Water for Injection, all presentations including 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-380-2013·2013-05-22

    Green Valley Drugs Recalls Lipotropic Injections Due to Sterility Concerns

    FVS Holdings, Inc. dba. Green Valley Drugs is recalling 209 vials of Lipotropic With Vitamin Injections nationwide due to a lack of assurance of sterility.

    Product
    Lipotropic With Vitamin Injections, all strengths and all presentations including a) Lipo W/ Vitamin 100 mL, b) Lipo W/ Vitamins 30 mL, c) Lipo W/Vitamin, d) Lipo w/Vitamins #5 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-393-2013·2013-05-22

    Green Valley Drugs Recalls Methylprednisolone Acetate Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Methylprednisolone Acetate Injection products because the company could not ensure the sterility of the compounded and repackaged items.

    Product
    Methylprednisolone Acetate Injection, all strengths and all presentations including a) Methylprednisolone Acetate 40 mg/mL, b) Methylprednisolone Acetate (PF) 40 mg/mL, c) Methylprednisolone Acetate (PF) 80 mg/mL, d) Methylpred Acetate 40 mg/mL 1 mL, e) Methylprednisolone 80 mg/5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-361-2013·2013-05-22

    Green Valley Drugs Recalls Edetate Disodium Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Edetate Disodium Injection because the pharmacy could not ensure the sterility of the compounded products.

    Product
    Edetate Disodium Injection, all strengths and all presentations including a) Edetate Disodium 150/30 mL and b) Edetate Disodium 150/100 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-374-2013·2013-05-22

    Green Valley Drugs Recalls Hydroxocobalamin Injection Due to Sterility Concerns

    Green Valley Drugs is recalling 135 vials of Hydroxocobalamin Injection nationwide due to a lack of assurance of sterility in its compounding and quality control processes.

    Product
    Hydroxocobalamin Injection, all strengths and all presentations including a) Hydroxocobalamin 1000 mcg/mL 30mL and b) Hydroxocobalamin 1000 mcg/mL 10 mL P.F., Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-398-2013·2013-05-22

    Green Valley Drugs Recalls Phenylephrine Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Phenylephrine Injection vials because the pharmacy could not ensure the products were sterile.

    Product
    Phenylephrine Injection, all strengths and all presentations including Phenylephrine 1% 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-364-2013·2013-05-22

    Green Valley Drugs Recalls Estradiol Cypionate Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Estradiol Cypionate Injection because the pharmacy could not ensure the products were sterile. The recall covers all strengths and presentations distributed nationwide.

    Product
    Estradiol Cypionate Injection, all strengths and all presentations including a) Estradiol Cypionate 5 mg/mL 10 mL and b) Estradiol Cypionate 10 mg/mL 10 ml, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-396-2013·2013-05-22

    Green Valley Drugs Recalls Modified Myers Cocktail Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Modified Myers Cocktail Injection vials because the pharmacy could not ensure the products were sterile.

    Product
    Modified Myers Cocktail Injection, all strengths and all presentations including a) Mod Meyer's Cocktail 37 mL and b) Modified Myers Cocktail 37 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide