The Recall Desk

Hazard

Lack Of Sterility recalls

1,423 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,423
Critical
3
Severe
1,055
Most recent
2026-10-14

Of the 1,423 lack of sterility recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,055 (74%) 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 lack of 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.

776–800 of 1423

  • SevereFDA (Drugs)·D-1188-2019·2019-04-24

    Lidocaine Injection Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Lidocaine 1%/Dextrose 12.5% Injection vials due to a lack of sterility assurance.

    Product
    Lidocaine 1%/Dextrose 12.5% (PF) Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1144-2019·2019-04-24

    Gentamicin Irrigation Syringes Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Gentamicin irrigation syringes due to a lack of sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Gentamicin 120 mg/250 mL 0.9% Sodium Chloride for Irrigation, 30 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1166-2019·2019-04-24

    Phenylephrine Injection Recalled Due to Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Phenylephrine 1 mg/mL Injection vials nationwide because the product lacks sterility assurance.

    Product
    Phenylephrine 1 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1200-2019·2019-04-24

    Prostaglandin Tri-Mix Injection Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Prostaglandin Tri-Mix Injection due to lack of sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Prostaglandin Tri-Mix 5:15:0.5 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1156-2019·2019-04-24

    Heparin and Lidocaine Syringes Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Heparin and Lidocaine syringes due to a lack of sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Heparin 20,000 U/Lidocaine 2% 10 mL/Sodium Bicarbonate 8.4% 10 mL/Sterile Water 5 mL, 27 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1151-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls HCG Vials Due to Sterility Concerns

    Anderson Compounding Pharmacy is recalling 99 vials of HCG 20 Day Extra Strength nationwide due to a lack of sterility assurance.

    Product
    HCG 20 Day Extra Strength, 3500 Units/4 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1162-2019·2019-04-24

    Methylcobalamin Injection Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Methylcobalamin 1 mg/mL Injection vials due to a lack of sterility assurance.

    Product
    Methylcobalamin 1 mg/mL Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1163-2019·2019-04-24

    Methylprednisolone Ophthalmic Drops Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Methylprednisolone 1% PF Ophthalmic drops due to a lack of sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Methylprednisolone 1% PF Ophthalmic, 3 mL Droppers, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1025-2019·2019-03-27

    Advanced Pharma Recalls Glycopyrrolate Injectable Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 140 syringes of Glycopyrrolate 0.6 mg/3 mL Injectable Solution because the company cannot ensure the product is sterile.

    Product
    Glycopyrrolate 0.6 mg/3 mL (0.2 mg per mL) Injectable Solution, 3 mL Sterile single use syringe, For IV or IM use, NDC: 42852-828-22 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1033-2019·2019-03-27

    Advanced Pharma Recalls Morphine Sulfate Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 2,325 syringes of Morphine Sulfate 30 mg/30 mL Injectable Solution nationwide due to a lack of assurance of sterility.

    Product
    Morphine Sulfate 30 mg/30 mL (1 mg/mL) Injectable Solution Morphine Sulfate 30 mg 0.9% Sodium Chloride QS 30 mL Sterile singe use syringe, NDC: 42852-241-63 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1024-2019·2019-03-27

    Advanced Pharma Recalls Neostigmine Methylsulfate Injection Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 5,700 syringes of Neostigmine Methylsulfate Injection Solution because there is a lack of assurance of sterility.

    Product
    Neostigmine Methylsulfate Injection Solution 5 mg/5mL (1 mg per mL), 5mL Sterile single use syringe, For IV use only, NDC: 42852-829-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1023-2019·2019-03-27

    Advanced Pharma Recalls Phenylephrine Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 22,900 syringes of Phenylephrine HCl injectable solution nationwide due to a lack of assurance of sterility.

    Product
    Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL), Sterile single use syringe, NDC: 42852-830-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1030-2019·2019-03-27

    Advanced Pharma Recalls Heparin Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 500 syringes of Heparin 10 Units/10 mL due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Heparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride, QS 10 mL, Injectable Solution, Dwell, 10mL Sterile single use syringe, NDC: 42852-725-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1022-2019·2019-03-27

    Advanced Pharma Recalls Phenylephrine Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 1,575 syringes of Phenylephrine HCl injectable solution because the company cannot guarantee the product is sterile.

    Product
    Phenylephrine HCl, 400 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 400 mcg/10 mL (40 mcg per mL), Sterile single use syringe, NDC: 42852-876-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1021-2019·2019-03-27

    Advanced Pharma Recalls Glycopyrrolate Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 2,580 syringes of Glycopyrrolate Injectable Solution nationwide due to a lack of assurance of sterility.

    Product
    Glycopyrrolate Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe, NDC: 42852-828-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0466-2019·2019-02-20

    Promise Pharmacy Recalls ICB-Complex Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 846 vials of ICB-Complex injection nationwide due to a lack of sterility assurance.

    Product
    ICB-Complex, injection,Inositol/Choline/B1/B2/B3/B5/B6/B12/Leucine/Carnitine/Chromium/Lidocaine: 25mg/25mg/5mg/2.5mg/25mg/5mg/5mg/0.1mg/1.5mg/25mg/25mg/10mg/ML, 10ml, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0463-2019·2019-02-20

    Promise Pharmacy Recalls Sermorelin Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 266 vials of Sermorelin 15mg injections because they lack sterility assurance. The products were distributed nationwide.

    Product
    Sermorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0476-2019·2019-02-20

    Promise Pharmacy Recalls Leucine/Isoleucine/Valine Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling Leucine/Isoleucine/Valine injection vials due to a lack of sterility assurance. The affected products were distributed nationwide.

    Product
    Leucine/Isoleucine/Valine injection, 10mg/10mg/5mg/mL/mL, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0461-2019·2019-02-20

    Promise Pharmacy Recalls HCG Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 2,595 vials of HCG injections nationwide due to a lack of sterility assurance.

    Product
    HCG, Human chorionic gonadotropin 5,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0432-2019·2019-02-20

    Promise Pharmacy Recalls Prednisolone and Moxifloxacin Eye Drops for Sterility Concerns

    Promise Pharmacy is recalling 43 bottles of compounded Prednisolone and Moxifloxacin ophthalmic solution due to a lack of sterility assurance.

    Product
    Prednisolone and Moxifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0439-2019·2019-02-20

    Promise Pharmacy Recalls Multi Trace Injection Due to Sterility Concerns

    Promise Pharmacy is recalling Multi Trace injection vials because they may lack sterility assurance. The recall covers 30 mL vials distributed nationwide.

    Product
    Multi Trace, Zinc/Copper/Manganese/Selenium 5mg/1mg/0.5mg/60mcg/ml, injection 30 mL, Rx Only, Compounded Prescription, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0448-2019·2019-02-20

    Promise Pharmacy Recalls Sermorelin Theanine/GHRP2 Injection Due to Sterility Concerns

    Promise Pharmacy is recalling Sermorelin Theanine/GHRP2 injections due to a lack of sterility assurance. The affected lot was distributed nationwide.

    Product
    Sermorelin Theanine/GHRP2, 15 mg/75 mg/5.4 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0447-2019·2019-02-20

    Promise Pharmacy Recalls Thymosin Beta-4 Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 94 vials of Thymosin Beta-4, 15 mg Injection due to a lack of sterility assurance. The product was distributed nationwide in the USA.

    Product
    Thymosin Beta-4, 15 mg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0449-2019·2019-02-20

    Promise Pharmacy Recalls Sermorelin Injections Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling 255 vials of Sermorelin 9 mg injection nationwide due to a lack of sterility assurance.

    Product
    Sermorelin 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide