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.

Class II · Moderate risk

Zantac 75 mg

CGMP Deviations: Presence of NDMA impurity detected in product.

Ongoing Nitrosamine impurity Sanofi-Aventis U.S. LLC D-0545-2020
Class II · Moderate risk

Zantac 150 mg

CGMP Deviations: Presence of NDMA impurity detected in product.

Ongoing Nitrosamine impurity Sanofi-Aventis U.S. LLC D-0544-2020

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