Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

893 recalls · Class II, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2017 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
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
Class II · Moderate risk

Neostigmine Methylsulfate

Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds current stability data.

Terminated Stability / shelf life Premier Pharmacy Labs Inc NDC 69623-234-15 D-0129-2018
Class II · Moderate risk

Povidone Iodine

Labeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% , the outer box had the correct label.

Terminated Labeling / mix-up Degasa Sa De Cv NDC 68345-350-09 D-1129-2017
Class II · Moderate risk

Vitamin A&D Ointment

Labeling Mixup; the individual A&D ointment foil packets are incorrectly labeled as petroleum jelly. The boxes and outer case are correctly labeled as A&D ointment.

Terminated Labeling / mix-up Medline Industries INC D-1138-2017
Class II · Moderate risk

Rugby Aller-chlor

Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination

Terminated Microbial contamination The Harvard Drug Group D-1122-2017
Class II · Moderate risk

Rugby Diocto Syrup

Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination

Terminated Microbial contamination The Harvard Drug Group D-1120-2017
Class II · Moderate risk

Rugby Diocto Liquid

Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination

Terminated Microbial contamination The Harvard Drug Group D-1119-2017
Class II · Moderate risk

Famotidine USP 20 mg

Failed Tablet/Capsule Specification: out of specification for tablet weight.

Terminated Failed specification PD-Rx Pharmaceuticals, Inc. NDC 55289-765-30 D-1057-2017
Class II · Moderate risk

Famotidine Tablets USP

Failed Tablet/Capsule Specification; out of specification for tablet weight

Terminated Failed specification Teva Pharmaceuticals USA NDC 0172-5728-60 D-1056-2017
Class II · Moderate risk

Entecavir Tablets 0.5 mg

Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.

Terminated Impurity / degradation Hetero USA Inc NDC 31722-833-30 D-1095-2017

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