Independent register of U.S. FDA drug recalls · updated Oct 13, 2026
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Class II drug recalls - moderate risk

Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.

14,543 recalls, newest first.

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

All Nitro Paste

Lack of Processing Controls

Terminated cGMP deviation Reliable Rexall-A Compounding Pharmacy D-1130-2016
Class II · Moderate risk

All Arimidex

Lack of Processing Controls

Terminated cGMP deviation Reliable Rexall-A Compounding Pharmacy D-1114-2016
Class II · Moderate risk

All Midrin

Lack of Processing Controls

Terminated cGMP deviation Reliable Rexall-A Compounding Pharmacy D-1110-2016

Recalls by year