Class II · Moderate risk Terminated
fentaNYL 500 mcg/250 mL
Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
Albuterol 2.5mg / Ipratropium 0.75mg/ Triamcinolone 0.5 mg 3ML Vial
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Albuterol 1.25mg / Ipratropium 0.5mg
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Albuterol 1.25mg / Ipratropium 0.5mg/ Budesonide 0.25mg
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Albuterol 2.5mg / Budesonide 0.5mg
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.25mg
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.5mg
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Albuterol 2.5mg / Ipratropium 0.75mg
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Albuterol 3.75mg / Ipratropium 0.75mg
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Budesonide 0.4mg
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Formoterol 12mcg / Budesonide 0.5mg
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Lidocaine HCl Injection
Reason Presence of Foreign Substance: Foreign material found inside the vial.
Class III · Low risk Terminated
Amiodarone Hydrochloride Injection
Reason Crystallization: Presence of visible particulate matter.
Class III · Low risk Terminated
Amiodarone Hydrochloride Injection
Reason Crystallization: Presence of visible particulate matter.
Class III · Low risk Terminated
Amiodarone Hydrochloride Injection
Reason Crystallization: Presence of visible particulate matter.
Class I · High risk Terminated
Bow & Arrow
Reason Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.
Class I · High risk Terminated
UP2, Dietary Supplement
Reason Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.
Class II · Moderate risk Terminated
R2103
Reason CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk Terminated
StellaLife VEGA Oral Gel Rinse
Reason CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk Terminated
Pareira
Reason CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk Terminated
Silicea 6X Tablets
Reason CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk Terminated
Natrum Sulphuricum 6X Tablets
Reason CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk Terminated
Natrum Phosphoricum 6X Tablets
Reason CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk Terminated
Natrum Muriaticum 6X Tablets
Reason CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk Terminated
Magnesia Phosphorica 6X Tablets
Reason CGMP Deviations: products were not manufactured under current good manufacturing practices.