Independent register of U.S. FDA drug recalls · updated Oct 12, 2026
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FDA Drug Recalls

6,161 recalls · Class II, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
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

Recalls by year