Independent register of U.S. FDA drug recalls · updated Oct 12, 2026
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Sterility & contamination

A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections.

6,317 FDA drug recalls with this cause, newest first.

This is the single biggest cause in the register by a wide margin. It covers products that had to be sterile - injectables, eye drops, certain ointments - but could not be verified sterile, or were found contaminated during testing. Most of these recalls come from compounding pharmacies and outsourcing facilities after an FDA inspection finds gaps in how sterile products were made. Sterility failures are treated seriously because the products involved have the least room for error, going straight into the bloodstream or the eye.

Class II · Moderate risk

Succinylcholine chloride 100 mg in 5 mL syringe

Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.

Terminated Sterility / contamination SSM Health Care St. Louis DBA SSM St. Clare Health Center D-0145-2018
Class II · Moderate risk

Phenylephrine 1000 mcg in 0.9% Sodium Chloride 10 mL

Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.

Terminated Sterility / contamination SSM Health Care St. Louis DBA SSM St. Clare Health Center D-0144-2018
Class II · Moderate risk

Oxytocin 30 units in 0.9% Sodium Chloride 500 mL

Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.

Terminated Sterility / contamination SSM Health Care St. Louis DBA SSM St. Clare Health Center D-0143-2018
Class II · Moderate risk

Norepinephrine 8 mg in dextrose 5% 250 mL

Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.

Terminated Sterility / contamination SSM Health Care St. Louis DBA SSM St. Clare Health Center D-0142-2018
Class II · Moderate risk

Neostigmine Methylsulfate 5 mg/5 mL

Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.

Terminated Sterility / contamination SSM Health Care St. Louis DBA SSM St. Clare Health Center D-0141-2018
Class II · Moderate risk

Morphine 50 mg in 0.9% Sodium Chloride 5 mL PCA

Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.

Terminated Sterility / contamination SSM Health Care St. Louis DBA SSM St. Clare Health Center D-0140-2018
Class II · Moderate risk

HYDROmorphone 10 mg in 0.9% Sodium Chloride 50 mL PCA

Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.

Terminated Sterility / contamination SSM Health Care St. Louis DBA SSM St. Clare Health Center D-0139-2018
Class II · Moderate risk

Amiodarone 900 mg in dextrose 5% 500 mL

Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.

Terminated Sterility / contamination SSM Health Care St. Louis DBA SSM St. Clare Health Center D-0137-2018
Class II · Moderate risk

Fentanyl 10 mcg in 0.9% Sodium Chloride 1 mL

Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.

Terminated Sterility / contamination SSM Health Care St. Louis DBA SSM St. Clare Health Center D-0136-2018