Class I · High risk Ongoing
Lubricant Eye Drops
Reason Non-Sterility
FDA Drug Recalls
17,898 recalls, newest first
Class I · High risk Ongoing
EQUATE brand Hydration PF Lubricant Eye Drops
Reason Non-Sterility
Class I · High risk Ongoing
Velocity Pharma brand Lubricating Eye Drop
Reason Non-Sterility
Class I · High risk Ongoing
Leader brand Lubricant Eye Drops
Reason Non-Sterility
Class I · High risk Ongoing
Target brand High Performance Lubricant Eye Drops
Reason Non-Sterility
Class I · High risk Ongoing
Leader brand Dry Eye Relief
Reason Non-Sterility
Class I · High risk Ongoing
CVS Health brand
Reason Non-Sterility
Class I · High risk Ongoing
Leader brand Eye Irritation Relief
Reason Non-Sterility
Class I · High risk Ongoing
CVS brand Multi Action Relief Drops
Reason Non-Sterility
Class I · High risk Ongoing
Leader brand Dry Eye Relief
Reason Non-Sterility
Class I · High risk Ongoing
CVS Health brand Lubricating Gel Drops
Reason Non-Sterility
Class I · High risk Ongoing
Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops
Reason Non-Sterility
Class I · High risk Ongoing
CVS Health brand Lubricant Eye Drops
Reason Non-Sterility
Class I · High risk Ongoing
Leader brand Lubricant Eye Drops
Reason Non-Sterility
Class I · High risk Ongoing
CVS Health brand Lubricant Eye Drops
Reason Non-Sterility
Class II · Moderate risk Ongoing
KinderMed INFANTS' PAIN & FEVER Acetaminophen
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Ongoing
KinderMed KIDS' PAIN & FEVER Acetaminophen
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
PAROXETINE tablets
Reason 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 Terminated
PAROXETINE tablets
Reason 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 Terminated
PAROXETINE tablets
Reason 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 Terminated
Testosterone Gel
Reason OOS for viscosity
Class III · Low risk Ongoing
Tropicamide 1%
Reason 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 Terminated
VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
SUCcinylcholine Chloride 100 mg/5mL Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
SUCcinylcholine Chloride 200 mg/10mL Injection
Reason Lack of Assurance of Sterility