Hazard

Sterility Failure recalls

1,693 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 1,693
Critical: 12
Severe: 938
Most recent: 2026-09-30

Of the 1,693 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 938 (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.

951–975 of 1693

SevereFDA (Drugs)·D-0160-2018·2018-01-17
Smiths Medical Recalls Sterile Eyewash Due to Leaking Containers
Smiths Medical is recalling 96,828 bottles of sterile eyewash because leaking containers may compromise sterility and expose users to infectious agents.
Product
Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 32 oz. 12 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061. Model Number: 32-005587
Category
Medical Device
Distribution
2 states
SevereFDA (Drugs)·D-0144-2018·2018-01-03
SSM St. Clare Recalls Phenylephrine Syringes Due to Sterility Concerns
SSM St. Clare Health Center is recalling compounded phenylephrine syringes because microbial growth was detected during a routine manufacturing simulation. No distributed product has been confirmed to contain microorganisms.
Product
Phenylephrine 1000 mcg in 0.9% Sodium Chloride 10 mL, 10 mL syringe, Concentration: 100 mcg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0104-01
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0141-2018·2018-01-03
SSM St. Clare Recalls Neostigmine Methylsulfate Syringes Due to Sterility Concerns
SSM St. Clare Health Center is recalling compounded Neostigmine Methylsulfate syringes because microbial growth was detected during a routine manufacturing simulation. No distributed product has been confirmed to contain microorganisms.
Product
Neostigmine Methylsulfate 5 mg/5 mL, 5 mL Syringe, Concentration: 1 mg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0329-01
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0137-2018·2018-01-03
SSM St. Clare Recalls Amiodarone Injectable Due to Sterility Concerns
SSM St. Clare Health Center is recalling a specific lot of compounded Amiodarone injectable bags due to a lack of sterility assurance. No distributed product has been confirmed to contain microorganisms.
Product
Amiodarone 900 mg in dextrose 5% 500 mL, 500 mL bag, Concentration: 1.8 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88890-0333-01
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0065-2018·2017-11-08
SCA Pharmaceuticals Recalls Oxytocin Bags Due to Sterility Concerns
SCA Pharmaceuticals is recalling 450 bags of oxyTOCIN 30 units in Lactated Ringers due to a lack of assurance of sterility.
Product
oxyTOCIN 30 units added to Lactated Ringers 500 mL Bag, Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0086-44
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0059-2018·2017-11-08
SCA Pharmaceuticals Recalls Succinylcholine Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 1,248 syringes of Succinylcholine 20 mg/mL due to a lack of assurance of sterility. The product was distributed nationwide.
Product
SUCcinylcholine 20 mg per mL, Total Volume 10 mL in single-dose syringe, (SUCcinylcholine 200 mg / 10 ml) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0910-29
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0024-2018·2017-11-01
Banner Pharmacy Recalls Ropivacaine HCL Cassettes Due to Sterility Concerns
Banner Pharmacy Services is recalling Ropivacaine HCL cassettes because the FDA determined there is a lack of assurance of sterility.
Product
Ropivacaine HCL (PF) 0.2% (2mg/mL) 100 mL Cassette Rx Only Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226 NDC 7025006301
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1147-2017·2017-09-20
Bella Pharmaceuticals Recalls Methylcobalamin Vials Due to Sterility Concerns
Bella Pharmaceuticals is recalling Methylcobalamin 10mg vials because the company cannot ensure the product is sterile.
Product
Methylcobalamin 10mg, (1mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1149-2017·2017-09-20
Bella Pharmaceuticals Recalls G.A.C Vials Due to Sterility Concerns
Bella Pharmaceuticals is recalling G.A.C 25/100/250mg vials because the company cannot ensure the product is sterile.
Product
G.A.C 25/100/250mg, 30 mL Vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3064-2017·2017-08-30
FDA Recalls Tissu-Trans Filtron 2000 Due to Sterile Seal Integrity Concerns
Shippert Medical Technologies is recalling 5,188 units of Tissu-Trans Filtron 2000 because the sterile package seal integrity cannot be assured.
Product
Tissu-Trans Filtron 2000, 3-TT-FILTRON 2000. Product Usage: Intended for fat transfer and liposuction.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1062-2017·2017-08-16
Cantrell Drug Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns
Cantrell Drug Company is recalling Ephedrine Sulfate in 0.9% Sodium Chloride single-dose syringes because of a lack of sterility assurance.
Product
Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL, 25 mg/5 mL (5 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-019-15
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1003-2017·2017-08-02
SCA Pharmaceuticals Recalls Magnesium Sulfate Injection Bags Due to Sterility Concerns
SCA Pharmaceuticals is recalling 40 bags of Magnesium Sulfate 4 g in 0.9% Sodium Chloride because they were made with recalled saline bags that may leak, compromising sterility.
Product
MAGNESIUM Sulfate 4 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0737-32.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0991-2017·2017-07-26
PharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns
PharMEDium Services is recalling specific lots of Potassium Phosphate in 0.9% Sodium Chloride Injection due to a media fill failure that compromised sterility assurance.
Product
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5284 NDC# 61553-284-48
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0990-2017·2017-07-26
PharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns
PharMEDium Services is recalling specific lots of Potassium Phosphate in 0.9% Sodium Chloride Injection due to a media fill failure that compromised sterility assurance.
Product
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 40 mMol in 250 mL in 250 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5301 NDC# 61553-301-11
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2751-2017·2017-07-26
BD 3ml Syringes Recalled for Insufficient Sterilization Irradiation
Becton Dickinson is recalling 648,000 units of BD 3ml Syringes because several lots did not receive the specified dose of irradiation required to meet the Sterility Assurance Level.
Product
BD 3ml Syringe Luer-Lok" Tip Catalog 309657 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0995-2017·2017-07-26
PharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns
PharMEDium Services is recalling specific lots of Potassium Phosphate in 5% Dextrose Injection due to a media fill failure that compromised sterility assurance.
Product
Potassium PHOSphate in 5% Dextrose Injection, 9 mMol in 50 mL in 50 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5310 NDC# 61553-310-41
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0986-2017·2017-07-26
PharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns
PharMEDium Services is recalling specific lots of Potassium Phosphate in 0.9% Sodium Chloride Injection due to a media fill failure that compromised sterility assurance.
Product
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 10 mMol in a) 100 mL in 150 mL Intravia Bag (NDC 61553-288-48) Service Code: 2K5288, and b) 250 mL in 250 mL Intravia Bag (NDC 61553-281-11) Service Code: 2K5281, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0989-2017·2017-07-26
PharMedium Recalls Potassium Phosphate Injection Due to Sterility Concerns
PharMedium Services is recalling specific lots of Potassium Phosphate in 5% Dextrose Injection due to a media fill failure that compromised sterility assurance.
Product
Potassium PHOSphate in 5% Dextrose Injection, 30 mMol 500 mL in 500 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5283 NDC# 61553-283-03
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0994-2017·2017-07-26
PharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns
PharMEDium Services is recalling specific lots of Potassium Phosphate Injection due to a media fill failure that compromised sterility assurance.
Product
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 9 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5286 NDC# 61553-286-48
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0992-2017·2017-07-26
PharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns
PharMEDium Services is recalling specific lots of Potassium Phosphate in 0.9% Sodium Chloride Injection because of a media fill failure that compromised sterility assurance.
Product
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7.5 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5298 NDC# 61553-298-48NDC# 61553-298-48
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0996-2017·2017-07-26
PharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns
PharMEDium Services is recalling specific lots of Potassium Phosphate in 0.9% Sodium Chloride Injection due to a media fill failure at the manufacturer that raises concerns about sterility.
Product
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 30 mMol in a) 250 mL in 250 mL Intravia Bag Service Code 2K5290 NDC# 61553-290-11, b) 500 mL in 500 mL Intravia Bag Service Code 2K5285 NDC# 61553-285-03, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0985-2017·2017-07-26
PharMedium Recalls Succinylcholine Chloride Injection Due to Sterility Concerns
PharMedium Services is recalling specific lots of Succinylcholine Chloride Injection due to a media fill failure that compromised sterility assurance.
Product
Succinylcholine Chloride Injection (Preserved) 20 mg per mL, 200 mg per 10 mL, 10 mL Total Volume in BD Syringe, For IV Use, PharMedium Services, LLC, Cleveland, MS --- NDC 61553-364-65
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0993-2017·2017-07-26
PharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns
PharMEDium Services is recalling specific lots of Potassium Phosphate in 5% Dextrose Injection due to a media fill failure that compromised sterility assurance.
Product
Potassium PHOSphate in 5% Dextrose Injection, 7.5 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5299 NDC# 61553-299-48
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2750-2017·2017-07-26
BD 3ml Syringes Recalled for Insufficient Sterilization Irradiation
Becton Dickinson is recalling 340,000 units of BD 3ml Syringes because several lots did not receive the specified dose of irradiation required to meet Sterility Assurance Level standards.
Product
BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #309580 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2748-2017·2017-07-26
BD SafetyGlide Injection Needle Recall Due to Sterility Assurance Issues
Becton Dickinson is recalling 29,500 units of BD SafetyGlide Injection Needles because several lots did not receive the specified dose of irradiation required to meet Sterility Assurance Level (SAL) standards.
Product
BD SafetyGlide" Injection Needle Catalog #305917 The SafetyGlide " needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below the surface of the skin, injection into intravenous ports and tubings external to the patient. The…
Category
Medical Device
Distribution
Distributed nationwide