fda/drug-recalls·Available

FDA Drug Recalls & Enforcement Actions

When a drug gets recalled, the FDA logs it here. You can see what was recalled, why (contamination, mislabeling, wrong dosage, etc.), how serious it was rated (Class I is most urgent), which company did the recalling, and where the bad product got shipped. This is useful if you're tracking supply chain disruptions, sudden price spikes for specific drugs, or safety patterns in a particular region.

Published by FDAView source Source and methodology

Source rows:: 18,048
Coverage:: 2012-06-20T00:00:00Z – 2026-10-21T00:00:00Z

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Source and methodology

Publisher

FDA

government

Type: government
Scope: us federal
Updates: scheduled
License: License not specified

How this data is collected

Covers all reported drug recalls: voluntary recalls from firms and FDA-mandated enforcement actions.
Classified as Class I (most serious), II, or III severity based on health risk assessment.
Updated as new enforcement actions are reported; dates include recall initiation and FDA center classification.
Source: FDA's official enforcement database; ~17,500 records total.

What to watch out for

Older records may lack complete geographic detail or product information.
Does not include international recalls of US-manufactured drugs unless reported to FDA.
Recall classification reflects FDA's initial assessment; outcomes or final determinations may differ.
Distribution pattern data may be incomplete for some recalls, especially older ones.
Dataset does not track actual market impact, shortages, or price changes resulting from recalls.

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