The Recall Desk

Hazard

Non Sterility recalls

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

What the numbers show

Total
145
Critical
85
Severe
55
Most recent
2026-07-01

Of the 145 non sterility recalls we have scored against our rubric, 85 (59%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 55 (38%) 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 non 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.

76–100 of 145

  • SevereFDA (Drugs)·D-1175-2017·2017-09-27

    Genentech Recalls Activase Due to Cracked Sterile Water Vials

    Genentech is recalling 16,882 units of Activase (alteplase) because the included sterile water vials may have cracked or chipped glass.

    Product
    Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 single-dose 100ml vial of sterile water for Injection USP and one transfer device. Manufactured by: Genentech, Inc. 1 DNA Way, South San Francisco, CA 84080-4990. NDC: 50242-0085-27
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0917-2017·2017-06-21

    FDA Recalls Non-Sterile Human Chorionic Gonadotropin Syringes

    Complete Pharmacy and Medical Solutions LLC is recalling 1,890 syringes of Human Chorionic Gonadotropin (HCG) due to confirmed mold contamination.

    Product
    Human Chorionic Gonadotropin, 125 IU HCG, in 0.5 ml syringe, subcutaneous administration, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-0918-2017·2017-06-21

    Complete Pharmacy Recalls Non-Sterile Human Chorionic Gonadotropin Vials

    Complete Pharmacy and Medical Solutions LLC is recalling 49 vials of Human Chorionic Gonadotropin due to confirmed bacterial contamination.

    Product
    Human Chorionic Gonadotropin, 15,000 IU per vial, lyophilized for injection, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0496-2017·2017-03-08

    United Exchange Recalls Non-Sterile Eye Wash Bottles Nationwide

    United Exchange Corporation is recalling 46,080 bottles of Eye Wash due to direct evidence of non-sterility contamination in two lots.

    Product
    EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0904-6491-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0216-2017·2016-12-28

    Honeywell Eyesaline Eyewash Recalled for Klebsiella Pneumoniae Contamination

    Sperian Eye & Face Protection is recalling 9,744 bottles of Honeywell Eyesaline Eyewash Sterile Isotonic Solution due to non-sterility and contamination with Klebsiella pneumoniae.

    Product
    Honeywell eyesaline Eyewash Sterile Isotonic Solution, sterile water 99%, 32 fl. oz. (946 ml.), Sperian Eye & Face Protection, Inc. (a Honeywell Company), Platteville, WI 53818
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0228-2017·2016-12-28

    Sermorelin/GHRP-6 Injection Recalled for Non-Sterility and Microbial Contamination

    Town and Country Compounding and Consultation Services is recalling Sermorelin/GHRP-6 Injection due to non-sterility and Bacillus circulans contamination.

    Product
    Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I, 2 mL vial, Rx, Town and Country Compounding and Consultation Services, Ridgewood, NJ 074502
    Category
    Drug
    Distribution
    4 states
  • CriticalFDA (Drugs)·D-0211-2017·2016-12-28

    Guardian Pharmacy Recalls Lidocaine Syringes Due to Failed Sterility Test

    Guardian Pharmacy Services is recalling 180 pre-filled Lidocaine HCL/Sodium Bicarb syringes because a sterility test failed. The product was distributed to two medical facilities in Texas.

    Product
    Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-0094-2017·2016-10-19

    B. Braun Recalls 5% Dextrose Injection Due to Fungal Contamination

    B. Braun Medical Inc. is recalling 57,408 units of 5% Dextrose Injection USP due to non-sterility caused by fungal contamination from leaking containers.

    Product
    5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun Medical Inc. Irvine, CA 92614-5895 USA, NDC 00264-1510-32
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0870-2016·2016-06-01

    Avastin Syringes Recalled for Bacterial Contamination

    AmEx Pharmacy is recalling 836 Avastin syringes nationwide because testing revealed bacterial contamination.

    Product
    Avastin (Bevacizumab) 1.25 mg/0.05 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL 32901.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0869-2016·2016-06-01

    Avastin Syringes Recalled for Bacterial Contamination

    AmEx Pharmacy is recalling 45 Avastin syringes nationwide because testing revealed bacterial contamination.

    Product
    Avastin (Bevacizumab) 2 mg/0.08 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL 32901.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1830-2015·2015-10-07

    Hartley Medical Recalls Non-Sterile Prolotherapy with Phenol Vials

    Hartley Medical Center Pharmacy is recalling 10 vials of Prolotherapy with Phenol due to non-sterility concerns. The product was distributed in California and Nevada.

    Product
    Prolotherapy with Phenol (Dextrose 25%, Glycerin 25%, Phenol 2.5%, QS SWI), 100 mL vial, Rx Only, Hartley Medical, (888) 671-2888
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1829-2015·2015-10-07

    Hartley Medical Recalls Prolotherapy with Phenol Vials Due to Non-Sterility

    Hartley Medical Center Pharmacy is recalling 14 vials of Prolotherapy with Phenol due to non-sterility concerns. The product was distributed in California and Nevada.

    Product
    Prolotherapy with Phenol (Dextrose 25%, Glycerin 10%, Lidocaine HCl 10%, Bupivacaine HCl 0.625%, Phenol 1%, QS SWI), 5 mL vial, Rx Only, Hartley Medical, (888) 671-2888
    Category
    Drug
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-1108-2015·2015-06-03

    Hospira Recalls Lactated Ringer's Irrigation Bags Due to Mold Contamination

    Hospira is recalling 24,744 bags of Lactated Ringer's Irrigation due to confirmed mold contamination. The product was distributed nationwide.

    Product
    LACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7828-08.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0982-2015·2015-05-13

    Physician Preferred Medical Recalls Epel 18 mg Estradiol Pellets Due to Sterility Failure

    Physician Preferred Medical, LLC is recalling Epel 18 mg Estradiol Pellets because the specific lot failed sterility testing. The product was distributed in Arizona and Kansas.

    Product
    Epel 18 mg Estradiol Pellet, For In Office Use Only, For In Office Administration Only, Not for Resale or Dispensing to an Individual Patient, Rx Only, Preferred Physician Medical LLC, 405-551-8216
    Category
    Drug
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-451-2015·2015-04-15

    Central Admixture Pharmacy Services Recalls TPN Bags Due to Sterility Failure

    Central Admixture Pharmacy Services is recalling 5 bags of Total Parenteral Nutrition (TPN) compounded for Walter Reed National Military Medical Center because sterility tests failed.

    Product
    Walter Reed Natl Mil Med Ctr (MD) Stock TPN D10% without Ca, Trophamine 12g, Dextrose 20g, compound vol: 200 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-441-2015·2015-04-15

    CAPS Recalls Neonate Starter IV Infusion Bags Due to Sterility Failure

    Central Admixture Pharmacy Services is recalling two bags of Neonate Starter IV infusion bags because they failed sterility tests for microbial contamination.

    Product
    The Medical Center of Aurora (CO) Neonate Starter 2% AA/D10W, Trophamine 2% Dextrose 10%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-437-2015·2015-04-15

    CAPS Recalls 20 Bags of TPN Neonatal Starter Bag for Sterility Failure

    Central Admixture Pharmacy Services is recalling 20 bags of University of Alabama Birmingham TPN Neonatal Starter Bag due to out-of-specification sterility test results.

    Product
    University of Alabama Birmingham TPN Neonatal Starter Bag, compound vol: 100 ml, Trophamine 4% Dextrose 10%, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box. each container is lined with a polystyrene insert; CAPS, Allentown, PA
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-456-2015·2015-04-15

    CAPS Recalls Trophamine UAC Solution Due to Sterility Test Failures

    Central Admixture Pharmacy Services is recalling Trophamine UAC Solution because it failed sterility tests for microbial contamination.

    Product
    Truman Medical Center Lakewood (MO) Trophamine UAC Solution, Trophamine 3.2g, compound vol: 100 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-464-2015·2015-04-15

    CAPS Recalls Lankenau Hospital TPN Neonatal Starter Bags for Sterility Failure

    Central Admixture Pharmacy Services is recalling six Lankenau Hospital TPN Neonatal Starter Bags due to out-of-specification sterility test results.

    Product
    Lankenau Hospital (PA) TPN Neonatal Starter Bag, Trophamine 2.5%, Dextrose 10%, Additives: heparin PF 62.5 units, Calcium Gluconate 500mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined…
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-444-2015·2015-04-15

    FDA Recalls Compounded Neonatal IV Infusion Bags Due to Sterility Failure

    Central Admixture Pharmacy Services is recalling compounded neonatal IV infusion bags because they failed sterility tests for microbial contamination.

    Product
    Adventist Hinsdale Hospital (IL) Neonatal Starter: Troph 2% Dex10%, Trophamine 2% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a…
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-439-2015·2015-04-15

    Central Admixture Pharmacy Services Recalls Compounded IV Infusion Bags

    Central Admixture Pharmacy Services is recalling 8 bags of compounded IV infusion bags due to out-of-specification sterility test results.

    Product
    Rose Medical Center (CO) Neonate D10 Bridge, Trophamine 3% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 350 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert…
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-467-2015·2015-04-15

    CAPS Recalls Neonatal TPN Bags Due to Sterility Test Failures

    Central Admixture Pharmacy Services is recalling five bags of neonatal TPN due to out-of-specification sterility test results.

    Product
    Texas Health Presbyterian Dallas Neonatal Admit TPN 4 GM, Trophamine 4g/dL, Dextrose 10%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-446-2015·2015-04-15

    CAPS Recalls Compounded TPN Infusion Bags Due to Sterility Failure

    Central Admixture Pharmacy Services is recalling four bags of compounded TPN infusion bags because they failed sterility tests for microbial contamination.

    Product
    Advocate Good Samaritan Hospital (IL) TPN Dextrose 10% Trophamine 2%, Trophamine 2% Dextrose 10%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS…
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-452-2015·2015-04-15

    Recall of Compounded TPN Bags Due to Sterility Test Failures

    Central Admixture Pharmacy Services is recalling five bags of compounded Total Parenteral Nutrition (TPN) because they failed sterility tests for microbial contamination.

    Product
    Walter Reed Natl Mil Med Ctr (MD) Stock TPN D10% with Ca, Trophamine 12g, Dextrose 20g, Additives: Calcium Gluconate 8mEq, compound vol: 200 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene…
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-463-2015·2015-04-15

    FDA Recalls Six Bags of Neonatal TPN Due to Sterility Failure

    Central Admixture Pharmacy Services is recalling six bags of compounded neonatal TPN because sterility tests failed. The product was distributed nationwide.

    Product
    Abington Memorial Hospital (PA) TPN Neonatal Starter> 1Kg, Amino Acids, Neonate 12.5g, Dextrose 10%, 500 ml, Additives: heparin PF 250 units, Calcium Gluconate 1250mg, compound vol: 500 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated…
    Category
    Drug
    Distribution
    Distributed nationwide