Class II · Moderate risk
Phenylephrine 0.8 mg/10 mL NS
Lack of sterility assurance.
FDA drug recalls in 2019
Every FDA drug recall initiated in 2019, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,788 recalls, newest first.
Class II · Moderate risk
Heparin Pork 30
Lack of sterility assurance.
Class II · Moderate risk
Chlorothiazide 100 mg
Lack of sterility assurance.
Class II · Moderate risk
CefTRIAXone 1 GM
Lack of sterility assurance.
Class II · Moderate risk
CeFAZolin 3 gm 100 mg/mL
Lack of sterility assurance.
Class II · Moderate risk
CeFAZolin 2 GM a) in NS 100 mL bag
Lack of sterility assurance.
Class II · Moderate risk
CeFAZolin 1 GM a) in NS 100 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Lidocaine 1% - Sodium Bicarbonate 8.4% 1:1
Lack of sterility assurance.
Class II · Moderate risk
Lidocaine 1% - Sodium Bicarb 8.4% 10:1
Lack of sterility assurance.
Class II · Moderate risk
Lidocaine Buffered with J-Tip 0.25 mL
Lack of sterility assurance.
Class II · Moderate risk
Alteplase 1 mg/mL 1 mL in 10 mL syringe
Lack of sterility assurance.
Class II · Moderate risk
Oxytocin 30 units in NS 500 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Norepinephrine 16 mg in NS 250 mL bag
Lack of sterility assurance.
Class II · Moderate risk
NICARdipine 25 mg in NS 250 mL EXCEL bag
Lack of sterility assurance.
Class II · Moderate risk
Magnesium Sulfate 6 GM in NS 50 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Magnesium Sulfate 4 GM in NS 50 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Magnesium Sulfate 2 GM in NS 50 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Magnesium Sulfate 1 GM in NS 50 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Labetalol 20 mg/4 mL
Lack of sterility assurance.
Class II · Moderate risk
Diltiazem 250 mg in NS 250 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Clindamycin 900 mg in NS 50 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Dexmedetomidine 400 mcg in NS 100 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Amoxicillin for Oral Suspension USP
Subpotent Product: assay results for Amoxicillin were below the specification limits.
Class II · Moderate risk
Divalproex Sodium Extended-Release Tablets
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Class III · Low risk
Morphine Sulfate Extended-Release Tablets
Failed Impurities/Degradation Specifications