Class II · Moderate risk
fentaNYL 500 mcg/250 mL
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
FDA Drug Recalls
1,563 recalls, newest first
Class II · Moderate risk
fentaNYL 500 mcg/250 mL
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk
Albuterol 2.5mg / Ipratropium 0.75mg/ Triamcinolone 0.5 mg 3ML Vial
Lack of Processing Controls
Class II · Moderate risk
Albuterol 1.25mg / Ipratropium 0.5mg
Lack of Processing Controls
Class II · Moderate risk
Albuterol 1.25mg / Ipratropium 0.5mg/ Budesonide 0.25mg
Lack of Processing Controls
Class II · Moderate risk
Albuterol 2.5mg / Budesonide 0.5mg
Lack of Processing Controls
Class II · Moderate risk
Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.25mg
Lack of Processing Controls
Class II · Moderate risk
Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.5mg
Lack of Processing Controls
Class II · Moderate risk
Albuterol 2.5mg / Ipratropium 0.75mg
Lack of Processing Controls
Class II · Moderate risk
Albuterol 3.75mg / Ipratropium 0.75mg
Lack of Processing Controls
Class II · Moderate risk
Budesonide 0.4mg
Lack of Processing Controls
Class II · Moderate risk
Formoterol 12mcg / Budesonide 0.5mg
Lack of Processing Controls
Class II · Moderate risk
Lidocaine HCl Injection
Presence of Foreign Substance: Foreign material found inside the vial.
Class III · Low risk
Amiodarone Hydrochloride Injection
Crystallization: Presence of visible particulate matter.
Class III · Low risk
Amiodarone Hydrochloride Injection
Crystallization: Presence of visible particulate matter.
Class III · Low risk
Amiodarone Hydrochloride Injection
Crystallization: Presence of visible particulate matter.
Class I · High risk
Bow & Arrow
Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.
Class I · High risk
UP2, Dietary Supplement
Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.
Class II · Moderate risk
R2103
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
StellaLife VEGA Oral Gel Rinse
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Pareira (Brava)
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Silicea 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Natrum Sulphuricum 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Natrum Phosphoricum 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Natrum Muriaticum 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.