Independent register of U.S. FDA drug recalls · updated Oct 12, 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.

14,535 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

Aprepitant Capsule

cGMP deviations: Temperature abuse

Terminated Temperature excursion Mckesson Medical-Surgical Inc. Corporate Office NDC 0781-2321-06 D-1027-2022
Class II · Moderate risk

Amoxicillin Capsules

cGMP deviations: Temperature abuse

Terminated Temperature excursion Mckesson Medical-Surgical Inc. Corporate Office NDC 0781-2613-01 D-1025-2022
Class II · Moderate risk

GlucaGen (glucagon)

cGMP deviations: Temperature abuse

Terminated Temperature excursion Mckesson Medical-Surgical Inc. Corporate Office NDC 0597-0260-10 D-1017-2022
Class II · Moderate risk

EPI-Pen Jr

cGMP deviations: Temperature abuse

Terminated Temperature excursion Mckesson Medical-Surgical Inc. Corporate Office NDC 49502-501-02 D-1012-2022
Class II · Moderate risk

Epidural Tray

cGMP deviations: Temperature abuse

Terminated Temperature excursion Mckesson Medical-Surgical Inc. Corporate Office D-1010-2022
Class II · Moderate risk

Betadine 5%

cGMP deviations: Temperature abuse

Terminated Temperature excursion Mckesson Medical-Surgical Inc. Corporate Office NDC 0065-0411-30 D-1008-2022
Class II · Moderate risk

Lidocaine Patch

cGMP deviations: Temperature abuse

Terminated Temperature excursion Mckesson Medical-Surgical Inc. Corporate Office NDC 42858-0118-30 D-1004-2022

Recalls by year