Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

9 recalls · Class III, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2015 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class III · Low risk

Fenofibric Acid Tablets 105 mg

Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the drug product.

Terminated Chemical / undeclared Tribute Pharmaceuticals US Inc. NDC 13310-102-07 D-0017-2016
Class III · Low risk

Fenofibric Acid Tablets

Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the drug product.

Terminated Chemical / undeclared Tribute Pharmaceuticals US Inc. NDC 13310-101-07 D-0016-2016
Class III · Low risk

ClomiPHENE CITRATE Tablets

Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.

Terminated Chemical / undeclared EMD Serono, Inc. NDC 0093-0041-03 D-1813-2015
Class III · Low risk

Imipramine HCl Tablets

Chemical Contamination; benzophenone leached from the product label varnish

Terminated Chemical / undeclared Mutual Pharmaceutical Company, Inc. NDC 54738-914-01 D-1425-2015
Class III · Low risk

Imipramine HCl Tablets

Chemical Contamination; benzophenone leached from the product label varnish

Terminated Chemical / undeclared Mutual Pharmaceutical Company, Inc. NDC 54738-913-01 D-1424-2015
Class III · Low risk

Imipramine HCl Tablets

Chemical Contamination; benzophenone leached from the product label varnish

Terminated Chemical / undeclared Mutual Pharmaceutical Company, Inc. NDC 54738-912-01 D-1423-2015

Recalls by year