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.

1526–1550 of 1691

  • SevereFDA (Drugs)·D-725-2013·2013-07-17

    Olympia Pharmacy Recalls Doxapram Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Doxapram 20 mg/ml Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Doxapram 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-703-2013·2013-07-17

    Olympia Pharmacy Recalls Beta Alanine Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Beta Alanine and L-Carnosine injections because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Beta Alanine 100 mg/ml / l-carnosine 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-726-2013·2013-07-17

    Olympia Pharmacy Recalls Enrofloxacin Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Enrofloxacin 20 mg/ml Injection because FDA inspection findings raised concerns about quality control and assurance of sterility.

    Product
    Enrofloxacin 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-695-2013·2013-07-17

    Olympia Pharmacy Recalls Alprostadil Due to Sterility Concerns

    Olympia Pharmacy is recalling Alprostadil 2000 mcg/ml because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Alprostadil 2000 mcg/ml, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-720-2013·2013-07-17

    Dexpanthenol Injection Recalled for Lack of Sterility Assurance

    Olympia Pharmacy is recalling Dexpanthenol 250 mg/ml Injection due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Dexpanthenol 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-750-2013·2013-07-17

    Olympia Pharmacy Recalls Medetomidine Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Medetomidine 2 mg/ml Injection because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Medetomidine 2 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-768-2013·2013-07-17

    Olympia Pharmacy Recalls Pentosan Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling three vials of compounded Pentosan 250 mg/ml Injection because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Pentosan 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-692-2013·2013-07-17

    Olympia Pharmacy Recalls Acetyl-D-Glucosamine Due to Sterility Concerns

    Olympia Pharmacy is recalling Acetyl-D-Glucosamine w/Chondroitin 200 mg/ml because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Acetyl-D-Glucosamine w/Chondroitin 200 mg/ml, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-715-2013·2013-07-17

    Cre-O-Pan Injection Recalled Due to Sterility Concerns

    Olympia Pharmacy is recalling Cre-O-Pan Injection because FDA inspection findings raised concerns about quality control processes and assurance of sterility.

    Product
    Cre-O-Pan Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-778-2013·2013-07-17

    Olympia Pharmacy Recalls Quadmix Due to Sterility Concerns

    Olympia Pharmacy is recalling three lots of Quadmix because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Quadmix, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-633-2013·2013-07-10

    Acetylcysteine 20% Solution Recalled Due to Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling Acetylcysteine 20% solution due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Acetylcysteine 20 % solution, 100 ml bottle, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-663-2013·2013-07-10

    Sodium Chloride Recall Due to Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling Sodium Chloride (23.4%) due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Sodium Chloride (23.4%), Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-637-2013·2013-07-10

    Cyclosporine 2% Ophthalmic Recalled Due to Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling Cyclosporine 2% ophthalmic due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Cyclosporine 2% ophthalmic, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-658-2013·2013-07-10

    Clinical Specialties Compounding Pharmacy Recalls Ophthalmic Dilation Gel

    Clinical Specialties Compounding Pharmacy is recalling ophthalmic dilation gel due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Ophthalmic dilation gel, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-680-2013·2013-07-10

    Vancomycin Recall Due to Sterility Concerns at Compounding Pharmacy

    Clinical Specialties Compounding Pharmacy is recalling Vancomycin 50 mg/ml due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Vancomycin 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-660-2013·2013-07-10

    Clinical Specialties Compounding Pharmacy Recalls Pap 300 mg-phent 10 mg-prost 100 mcg

    Clinical Specialties Compounding Pharmacy is recalling specific lots of Pap 300 mg-phent 10 mg-prost 100 mcg due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Pap 300 mg-phent 10 mg-prost 100 mcg, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-639-2013·2013-07-10

    Estradiol Cypionate Injection Recalled Due to Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling Estradiol Cypionate 5 mg/ml injections due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Estradiol Cypionate 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Drugs)·D-624-2013·2013-07-10

    Baxter Recalls Sodium Chloride Injection Due to Sterility Concerns

    Baxter Healthcare is recalling specific lots of 0.9% Sodium Chloride Injection due to a manufacturing defect that may compromise sterility.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-590-2013·2013-06-12

    Pentec Health Recalls Proplete 80+ KG Due to Sterility Concerns

    Pentec Health is recalling Proplete 80+ KG renal nutritional prescriptions because sterility could not be assured for the compounded sterile products.

    Product
    Proplete 80+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 710mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-582-2013·2013-06-12

    Pentec Health Recalls Baxter Ultrabag Amino Acids Due to Sterility Concerns

    Pentec Health is recalling Baxter Ultrabag 1.5% Amino Acids because sterility could not be assured for compounded sterile renal nutritional prescriptions.

    Product
    Baxter Ultrabag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1500mL and b) 3000mL bags. Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-593-2013·2013-06-12

    Pentec Health Recalls Baxter LL Bag 1% Amino Acids Due to Sterility Concerns

    Pentec Health is recalling Baxter LL bag 1% Amino Acids w/KCL because sterility could not be assured for these compounded sterile renal nutritional prescriptions.

    Product
    Baxter LL bag 1% Amino Acids w/KCL (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids and KCL), in 3000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
    Category
    Drug
    Distribution
    0 states