Every FDA drug recall initiated in 2024, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
557 recalls, newest first.
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
CGMP Deviations: Released product should have been rejected.
Labeling: Not Elsewhere Classified - Wrong NDC number
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
CGMP Deviations: lack of adequate release testing.
Presence of Particulate Matter: Potential for glass delamination from the vials.
Presence of Particulate Matter: Potential for glass delamination from the vials.
Presence of Particulate Matter: Potential for glass delamination from the vials.
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Subpotent drug
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Failed Impurity/Degradation Specifications
Failed Impurity/Degradation Specifications
cGMP Deviations: Out of specification results for micro in hand soap products.
cGMP Deviations: Out of specification results for micro in hand soap products.
cGMP Deviations: Out of specification results for micro in hand soap products.
cGMP Deviations: Out of specification results for micro in hand soap products.