Class III · Low risk Ongoing
Methotrexate Tablets
Reason Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.
FDA Drug Recalls
2,661 recalls, newest first
Class I · High risk Ongoing
SANDIMMUNE Oral Solution
Reason Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Class I · High risk Ongoing
TheraBreath for Kids! Oral Rinse
Reason Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
Class II · Moderate risk Ongoing
octiq Lubricating Eye Drops
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
MAJOR LubriFresh P.M. Nighttime Ointment
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes
Reason Lack of Assurance of Sterility
Class I · High risk Ongoing
Dr. Berne's MSM DROPS 5% Solution
Reason Non-Sterility
Class II · Moderate risk Ongoing
Dr. Berne's MSM DROPS 5% Solution
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Dr. Berne's Organic Castor Oil Eye Drops
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Dr. Berne's MSM MIST 15% Solution
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Dr. Berne's MSM DROPS 15% Solution
Reason CGMP Deviations