FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Ongoing Apr 18, 2025
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.
Class II · Moderate risk Ongoing Apr 18, 2025
Reason Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Class II · Moderate risk Ongoing Apr 18, 2025
Reason Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Class II · Moderate risk Ongoing Apr 18, 2025
Reason cGMP Deviations
Class I · High risk Ongoing Apr 17, 2025
Reason Presence of Particulate Matter
Class II · Moderate risk Ongoing Apr 15, 2025
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing Apr 15, 2025
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…
Class III · Low risk Terminated Apr 15, 2025
Reason Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
Class II · Moderate risk Terminated Apr 15, 2025
Reason cGMP deviations
Class II · Moderate risk Terminated Apr 15, 2025
Reason cGMP deviations
Class II · Moderate risk Terminated Apr 15, 2025
Reason cGMP deviations
Class II · Moderate risk Terminated Apr 15, 2025
Reason cGMP deviations
Class II · Moderate risk Terminated Apr 15, 2025
Reason cGMP deviations
Class II · Moderate risk Terminated Apr 15, 2025
Reason cGMP deviations
Class I · High risk Ongoing Apr 14, 2025
Reason Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Class I · High risk Ongoing Apr 14, 2025
Reason Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Class I · High risk Ongoing Apr 14, 2025
Reason Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil…
Class I · High risk Ongoing Apr 14, 2025
Reason Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Class I · High risk Ongoing Apr 14, 2025
Reason Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Class II · Moderate risk Ongoing Apr 14, 2025
Reason CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II · Moderate risk Ongoing Apr 14, 2025
Reason CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II · Moderate risk Ongoing Apr 14, 2025
Reason CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Class II · Moderate risk Ongoing Apr 10, 2025
Reason Subpotent
Class II · Moderate risk Ongoing Apr 10, 2025
Reason Subpotent
Class II · Moderate risk Ongoing Apr 10, 2025
Reason Subpotent