Class II · Moderate risk
Phenylephrine HCl
Lack of Assurance of Sterility
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
Morphine Sulfate 30 mg/30 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl
Lack of Assurance of Sterility
Class II · Moderate risk
Heparin 5
Lack of Assurance of Sterility
Class II · Moderate risk
Heparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Esmolol HCl Injectable Solution 100 mg/10 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl
Lack of Assurance of Sterility
Class II · Moderate risk
2% Lidocaine HCl Injectable Solution
Lack of Assurance of Sterility
Class II · Moderate risk
2% Lidocaine HCl Injectable Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Glycopyrrolate 0.6 mg/3 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Neostigmine Methylsulfate Injection Solution 5 mg/5mL
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl
Lack of Assurance of Sterility
Class II · Moderate risk
Glycopyrrolate Injectable Solution 1 mg/5 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl
Lack of Assurance of Sterility
Class II · Moderate risk
Midazolam Benzodiazepine 50 mg/50 mL
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 2500 mcg/250 mL Injectable Solution
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class III · Low risk
Testosterone Topical Solution
Defective Container: Repetitive complaints received indicating pump not working.
Class II · Moderate risk
Dr. Berne's MSM DROPS 15% Solution
Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Class II · Moderate risk
Red Eye
Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Class II · Moderate risk
Dry Eye
Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Class II · Moderate risk
15% Msm
Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Class II · Moderate risk
Hydrocortisone and Acetic Acid Otic Solution
Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.