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.

Class II · Moderate risk

Cold Relief

cGMP deviations

Terminated cGMP deviation Ultra Seal Corporation NDC 42961-112-03 D-0483-2022
Class II · Moderate risk

Back Pain-Off

cGMP deviations

Terminated cGMP deviation Ultra Seal Corporation NDC 47682-073-00 D-0476-2022
Class II · Moderate risk

Ephedrine Plus

cGMP deviations

Terminated cGMP deviation Ultra Seal Corporation NDC 65193-320-24 D-0473-2022
Class II · Moderate risk

Chloresin

cGMP deviations

Terminated cGMP deviation Ultra Seal Corporation NDC 51532-0107-2 D-0468-2022
Class II · Moderate risk

Proctofoam HC

cGMP deficiencies

Terminated cGMP deviation Mylan Pharmaceuticals Inc NDC 0037-6822-10 D-0452-2022
Class II · Moderate risk

Lexette (halobetasol propionate)

CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.

Ongoing cGMP deviation Mayne Pharma Inc NDC 51862-604-50 D-0387-2022

Recalls by year