The Recall Desk

Hazard

Lack Of Sterility recalls

1,417 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,417
Critical
3
Severe
1,048
Most recent
2026-07-29

Of the 1,417 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 1,048 (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.

1326–1350 of 1417

  • SevereFDA (Drugs)·D-0265-2015·2014-12-03

    Perry Drug Recalls HCG Vials Due to Sterility Assurance Concerns

    Perry Drug Inc. is recalling HCG Low Dose vials in Kansas and Missouri due to quality control issues affecting sterility assurance.

    Product
    HCG Low Dose 30 IU/0.1 mL, 5 Ml vial, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0231-54
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0274-2015·2014-12-03

    Perry Drug Recalls Compounded HCG Injections Due to Sterility Concerns

    Perry Drug Inc. is recalling compounded HCG injections in Kansas and Missouri due to potential sterility assurance issues identified during an FDA inspection.

    Product
    HCG - 10,000 Unit PF Inject, 1mL Syringe, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS NDC 88888-0216-49
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0259-2015·2014-12-03

    Perry Drug Recalls Compounded Testosterone Syringes Due to Sterility Concerns

    Perry Drug Inc. is recalling compounded Testosterone CYP-250/PROP-20 mg syringes in Kansas and Missouri due to quality control issues affecting sterility assurance.

    Product
    Testosterone CYP-250/PROP-20 mg, 10 Ml Syringe, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0326-44
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0270-2015·2014-12-03

    Perry Drug Recalls Human Chorionic Gonadotropin Injections for Sterility Concerns

    Perry Drug Inc. is recalling HCG injections due to quality control issues that may compromise sterility assurance.

    Product
    2Ml HCG 10,000 U/ MB12 - 12,000 MCG/10 Ml Inj, 0.25ML (250IU), Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-7945-17
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0176-2015·2014-11-12

    FDA Recalls Injectable Ascorbic Acid Vials Due to Sterility Concerns

    Oregon Compounding Centers is recalling injectable ascorbic acid vials because quality control issues observed during an FDA inspection present a potential risk to sterility assurance.

    Product
    ASCORBIC ACID (with Preservative), 500 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0178-2015·2014-11-12

    FDA Recalls Bevacizumab/Dexamethasone Injectable Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Bevacizumab/Dexamethasone injectable syringes due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    BEVACIZUMAB/DEXAMETHASONE, 1.25/0.5 mL, Injectable, 0.05 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0231-2015·2014-11-05

    Specialty Compounding Recalls All Prescription Products Due to Sterility Concerns

    Specialty Compounding, LLC is recalling all prescription products manufactured by the company due to a lack of assurance of sterility.

    Product
    All products, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0163-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Tri-mix T105 Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Tri-mix T105 injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    Tri-mix T105, 30 mg/1 mg/10 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2076-2014·2014-07-23

    Pioneer Surgical Technology Recalls Tritium Sternal Plate System Due to Sterility Concerns

    Pioneer Surgical Technology is recalling 5 units of the Tritium Sternal Plate System in Texas and Florida due to a lack of sterility assurance.

    Product
    Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. The Pioneer Surgical Cable Plate System is used in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgica
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1404-2014·2014-06-25

    John W Hollis Inc Recalls Lipotropic Gold Injectable Due to Sterility Concerns

    John W Hollis Inc is recalling 80 mL vials of Lipotropic Gold injectable products because they may lack sterility assurance.

    Product
    LIPOTROPIC GOLD, Each mL contains: Levocarnitine 5 mg, Thiamine 50 mg, Riboflavin-5 phosphate 5mg, Niacinimide 50mg, Calcium Pantothenate 5 mg, Cyanocobalamin 1mg, Methionine 12.5mg, Choline 25mg, Inositol 25 mg, Sterile Water For injection, JOHN HOLLIS Pharmacist, Inc,110 20th A
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1395-2014·2014-06-25

    John W Hollis Recalls Levocarnitine Injection Due to Sterility Concerns

    John W Hollis Inc. is recalling Levocarnitine Solution for injection because the company cannot ensure the product is sterile. The recall covers specific lots distributed nationwide.

    Product
    Levocarnitine Solution for injection, l-Carnitine 50 mg, Also Contains Sterile Water for Injection and Benzyl Alcohol pH adjusted with HCl, 50 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1396-2014·2014-06-25

    John W Hollis Inc Recalls Methylcobalamin Injectable Due to Sterility Concerns

    John W Hollis Inc is recalling Methylcobalamin 1000 mcg injectable products because they lack assurance of sterility. The recall covers Lot # 1862 distributed nationwide.

    Product
    METHYLCOBALAMIN FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY, Methylcobalamin 1000 mcg, Also Contains: Benzyl Alcohol, Sodium Chloride, Water, Hydrochloric Acid, and/or Sodium Hydroxide, 30 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1406-2014·2014-06-25

    John W Hollis Recalls Polidocanol 1% Injection Due to Sterility Concerns

    John W Hollis Inc. is recalling Lot 2868 of Polidocanol 1% Solution for Injection because the company cannot ensure the product is sterile.

    Product
    Polidocanol 1% Solution for Injection, each mL contains Polidocanol (Laureth 9) 10 mg, also contains Sterile Water for Injection, Ethyl Alcohol, Anhydrous Chlorobutanol, 50 mL, JOHN HOLLIS Pharmacist, Inc. 110 B2 Avenue N, Nashville, TN 37203, 615-327-3234
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1101-2014·2014-03-12

    Bladder Instillation Recalled for Lack of Sterility Assurance

    Natures Pharmacy & Compounding Center is recalling all lots of Bladder Instillation due to quality control concerns affecting sterility assurance.

    Product
    Bladder Instillation
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1126-2014·2014-03-12

    Papaverine Injection Recalled for Lack of Sterility Assurance

    Natures Pharmacy & Compounding Center is recalling Papaverine 1nj 30mg/ml due to quality control concerns that present a potential risk to sterility assurance.

    Product
    Papaverine 1nj 30mg/ml
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1109-2014·2014-03-12

    FDA Recalls Estradiol and Testosterone Compounds for Sterility Concerns

    Natures Pharmacy & Compounding Center is recalling all lots of Estradiol Cypionate and Testosterone Cypionate due to sterility assurance concerns identified during an FDA inspection.

    Product
    Estradiol Cypionate 2mg/cc testosterone cypionoate 50mg
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1105-2014·2014-03-12

    Natures Pharmacy Recalls Cyano B-12 Due to Sterility Concerns

    Natures Pharmacy & Compounding Center is recalling Cyano B-12 (Cmpd) 1000mcg/ml due to quality control issues affecting sterility assurance.

    Product
    Cyano B-12 (Cmpd) 1000mcg/ml
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1140-2014·2014-03-12

    Vancomycin Eye Drops Recalled for Sterility Assurance Concerns

    Natures Pharmacy & Compounding Center is recalling all lots of Vancomycin (fortified) 25mg/ml ophthalmic solution due to quality control issues affecting sterility assurance.

    Product
    Vancomycin (fortified) 25mg/ml opth
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-438-2014·2014-01-22

    Phenol Injectable Recalled Due to Lack of Sterility Assurance

    Specialty Medicine Compounding Pharmacy is recalling Phenol, 6%, Injectable, because sterility cannot be assured after a related product was found non-sterile.

    Product
    Phenol, 6%, Injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-422-2014·2014-01-22

    Gatifloxacin Ophthalmic Drops Recalled for Lack of Sterility Assurance

    Specialty Medicine Compounding Pharmacy is recalling repackaged Gatifloxacin ophthalmic drops because sterility cannot be assured due to shared compounding practices with a non-sterile product.

    Product
    Gatifloxacin, 0.2ml 0.5% (ophthalmic) (repackaged), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-416-2014·2014-01-22

    Cyclopentolate HCL Ophthalmic Recall Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Cyclopentolate HCL ophthalmic products because sterility cannot be assured after a related product was found non-sterile.

    Product
    CYCLOPENTOLATE HCL* (FOR COMPOUNDING) 2% OPHTHALMIC, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-447-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Hydroxyprogesterone Injectable Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Hydroxyprogesterone 17alpha-PF 250 mg/mL injectable because sterility cannot be assured after a related product was found non-sterile.

    Product
    HYDROXYPROGEST*-17ALPHA -PF 250 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-448-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Quad Mix Injectable Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Quad Mix injectable products because sterility cannot be assured after a related product was found non-sterile.

    Product
    QUAD MIX* IN NACL (1.8/0.2/0.02)mg/18 mcg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state