Independent register of U.S. FDA drug recalls · updated Oct 14, 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.

Class II · Moderate risk

ZYFLO CR (zileuton)

Failed Dissolution Specifications: Out of specification result for dissolution.

Terminated Dissolution failure Chiesi USA, Inc. NDC 10122-902-12 D-1341-2019
Class II · Moderate risk

Sn-d

Lack of Processing Controls.

Terminated cGMP deviation Synthetopes Inc D-1403-2019
Class II · Moderate risk

Pentreotide

Lack of Processing Controls.

Terminated cGMP deviation Synthetopes Inc D-1399-2019

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