Class II · Moderate risk
PAROXETINE tablets
Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
FDA drug recalls in 2023
Every FDA drug recall initiated in 2023, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,122 recalls, newest first.
Class II · Moderate risk
PAROXETINE tablets
Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
Class II · Moderate risk
PAROXETINE tablets
Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
Class III · Low risk
Testosterone Gel
OOS for viscosity
Class III · Low risk
Tropicamide 1%
Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper
Class II · Moderate risk
VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection
Lack of Assurance of Sterility
Class II · Moderate risk
SUCcinylcholine Chloride 100 mg/5mL Injection
Lack of Assurance of Sterility
Class II · Moderate risk
SUCcinylcholine Chloride 200 mg/10mL Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Sodium Citrate 4% 3 mL
Lack of Assurance of Sterility
Class II · Moderate risk
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
neostigmine methylsulfate 5 mg/5 mL Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
labetalol HCl 20 mg/4mL Injection
Lack of Assurance of Sterility
Class II · Moderate risk
HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride
Lack of Assurance of Sterility