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-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-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-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-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-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-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-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-442-2015·2015-04-15

    Central Admixture Pharmacy Services Recalls Non-Sterile Neonatal TPN Bags

    Central Admixture Pharmacy Services is recalling four bags of neonatal TPN solution due to failed sterility tests indicating microbial contamination.

    Product
    Bridgeport Hospital (CT)TPN Neonatal Standard Solution, Trophamine 6% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, Calcium Gluconate 4mEq/L, compound vol: 150 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is
    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-462-2015·2015-04-15

    Central Admixture Pharmacy Services Recalls TPN Neonatal Starter Bags

    Central Admixture Pharmacy Services is recalling TPN Neonatal Starter IV infusion bags due to out-of-specification sterility test results.

    Product
    Abington Memorial Hospital (PA) TPN Neonatal Starter 0.4-0.599 Kg, Amino Acids, Neonate 3g, Dextrose 5%, 150 ml, Additives: heparin PF 75 units, Calcium Gluconate 300mg, compound vol: 150 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-449-2015·2015-04-15

    FDA Recalls Non-Sterile Neonatal TPN Bags Due to Microbial Contamination

    Central Admixture Pharmacy Services is recalling 10 bags of neonatal TPN due to failed sterility tests indicating microbial contamination.

    Product
    Holy Cross Hospital (MD) AA3%TPN Neonatal Day 1 Bag, Trophamine 10%/3% Dextrose 70%/10%, Additives: Calcium Gluconate 0.46 mEq/mL, 5mEq, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-458-2015·2015-04-15

    CAPS Recalls Neonatal IV Infusion Bags Due to Sterility Test Failures

    Central Admixture Pharmacy Services is recalling 4 bags of compounded neonatal IV infusion bags because they failed sterility tests for microbial contamination.

    Product
    Robert Wood Johnson University (NJ) Neonatal Starter 10% Dextrose, Trophamine 5%, 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-445-2015·2015-04-15

    Central Admixture Pharmacy Services Recalls Compounded TPN Infusion Bags

    Central Admixture Pharmacy Services is recalling 4 bags of compounded TPN infusion bags due to non-sterility test failures.

    Product
    Advocate Good Samaritan Hospital (IL) TPN Dextrose 5% Trophamine 2%, Trophamine 5% Dextrose 2%, 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,
    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-448-2015·2015-04-15

    Central Admixture Pharmacy Services Recalls NICU TPN Starter Due to Sterility Failure

    Central Admixture Pharmacy Services is recalling a specific lot of NICU TPN Starter IV bags because sterility tests showed microbial contamination.

    Product
    Olathe Medical Center (KS) NICU TPN Starter: Ingredients per 80 ml, Trophamine 3g Dextrose 10%, Additives: Calcium Gluconate 250mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a pol
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-469-2015·2015-04-15

    FDA Recalls Two Bags of Neonatal TPN Due to Sterility Failure

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

    Product
    Spotsylvania Regional Med Ctr (VA) TPN Neonatal Starter Bag, Trophamine 5 gm , 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-465-2015·2015-04-15

    Central Admixture Pharmacy Services Recalls Non-Sterile TPN Infusion Bags

    Central Admixture Pharmacy Services is recalling 3 bags of compounded TPN infusion bags due to non-sterility test failures.

    Product
    Bayshore Medical Center (TX) 10% Dextrose Starter Neo TPN, Trophamine 2.4% , Dextrose 10%, Additives: heparin PF 1 unit(s)/ml, Calcium Gluconate 2.3mEq/dL, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each conta
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-450-2015·2015-04-15

    Central Admixture Pharmacy Services Recalls Non-Sterile Neonatal TPN Bags

    Central Admixture Pharmacy Services is recalling four bags of neonatal TPN due to non-sterility test failures. The product was distributed nationwide.

    Product
    Sinai Hospital (MD) TPN Neonatal Day 1 Bag, Trophamine 10 g, Dextrose 25 g, Additives: Calcium Gluconate 1500 mg, 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; C
    Category
    Drug
    Distribution
    Distributed nationwide