723 recalls, newest first
Reason Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified…
Reason cGMP deviations and lack of assurance of sterility.
Reason cGMP deviations and lack of assurance of sterility.
Reason cGMP deviations and lack of assurance of sterility.
Reason cGMP deviations and lack of assurance of sterility.
Reason cGMP deviations and lack of assurance of sterility.
Reason CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
Reason CGMP Deviations; potential temperature excursions due to transit delays
Reason CGMP Deviations; potential temperature excursions due to transit delays
Reason CGMP Deviations; potential temperature excursions due to transit delays
Reason Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Reason Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Reason Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Reason Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Reason Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Reason cGMP Deviations
Reason Presence of Particulate Matter
Reason Lack of Assurance of Sterility
Reason Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024…
Reason Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Reason Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Reason Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil…
Reason Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Reason Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Reason CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.