FDA Recall Statistics 2026
Comprehensive analysis of FDA drug and device recalls — total counts, severity classifications, top companies, geographic distribution, and trends. Sourced from official FDA enforcement databases, updated regularly.
Key Figures
| Metric | Value |
|---|---|
| Total FDA recalls tracked | 87,007 |
| Average recalls per year (last 10 years) | 5,054 |
| Recalls initiated in 2026 | 2,715 |
| Class I (most severe) share | 21.0% (18,231 recalls) |
| Company with most recalls | zimmer biomet (875) |
| Most common recall reason | Other (34,794) |
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Overview
A high-level snapshot of FDA drug and device recall activity across all classifications and product types.
Recalls by Classification
The FDA classifies recalls by health risk severity. Class I recalls are the most serious, involving products that could cause serious health consequences or death. Class II may cause temporary or medically reversible adverse effects. Class III are unlikely to cause adverse health consequences.
Recalls by Product Type
FDA recalls cover both pharmaceutical drugs and medical devices. Device recalls have historically outnumbered drug recalls significantly.
Top Companies by Recall Count
The 20 companies with the most FDA recalls across all product types and classifications.
| # | Company | Total Recalls |
|---|
Top Companies by Class I Recalls
Companies with the most Class I (most severe) recalls — products that could cause serious health consequences or death.
| # | Company | Class I Recalls |
|---|
Geographic Distribution
Top 10 U.S. states by number of recalls issued. Concentration tends to correlate with states that have large pharmaceutical and medical device manufacturing sectors.
Year-over-Year Trends
Annual recall counts over the last 10 years, showing the trend in FDA enforcement activity.
Monthly Trends (Last 24 Months)
Recent monthly recall activity, useful for identifying seasonal patterns or enforcement surges.
Common Recall Reasons
The most frequently cited reasons for FDA recalls, categorized from free-text descriptions in enforcement reports.
Frequently Asked Questions
How many FDA recalls are there per year?
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What is a Class I recall?
A Class I recall is the most serious type of FDA recall. It involves a situation where there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. Examples include contaminated blood products, mislabeled drugs with potentially lethal dosing errors, or defective life-sustaining medical devices.
Which company has the most FDA recalls?
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What percentage of FDA recalls are Class I?
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Explore FDA Recall Data Further
- Browse Class I FDA recalls — the most serious recall classification
- Browse all FDA recalls by date, or by year via the 2026 FDA activity hub
- FDA recall trends: what the data shows — full written analysis
- Trace a recall to the manufacturing facility
- Related dashboards: FDA inspection statistics, warning letter & compliance statistics, drug shortage statistics
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Get API Key — Free/api/stats/recalls endpoint.Disclaimer: This analysis is provided for informational purposes only and should not be used as the sole basis for regulatory decisions.