Why are drugs recalled?
The most common reason is how a drug was made: 673 of the 4,274 drug recalls the FDA classified from 2013 through 2025 (about 16%) were for not following good manufacturing practices. Impurities or contamination (542), mix-ups and label errors (504) and sterile drugs that can't be shown to be sterile (495) come next. Chartly grouped FDA's written reasons by their key words; each recall counts once, under its main reason.
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Key facts
Measure: Drug recalls since 2013. Written from the data below.
- Not made under good manufacturing practices has the highest figure, 673, followed by Impurities or contamination (542) and Mix-ups and label errors (504).
- Other has the lowest figure, 20, followed by Germs in a product that needn't be sterile (114) and Faulty container or delivery device (191).
- The highest is 34 times the lowest.
Source and date
- Data as of
- Published
Citation
Chartly. “Why are drugs recalled?” Chart. Data: U.S. Food and Drug Administration, Enforcement Reports (openFDA drug recall data), https://open.fda.gov/apis/drug/enforcement/ (data as of December 31, 2025). https://chart.ly/charts/why-are-drugs-recalled (accessed October 15, 2026).
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The data
Download data (CSV)The file has the numbers in this table, with the source, license and date. Please credit the source and Chartly.
| Reason for the recall | Drug recalls since 2013 |
|---|---|
| Not made under good manufacturing practices | 673 |
| Impurities or contamination | 542 |
| Mix-ups and label errors | 504 |
| Can't be shown to be sterile | 495 |
| Particles or foreign matter | 443 |
| Too strong or too weak | 415 |
| Failed stability or other quality checks | 349 |
| Doesn't dissolve as it should | 285 |
| Sold without FDA approval | 243 |
| Faulty container or delivery device | 191 |
| Germs in a product that needn't be sterile | 114 |
| Other | 20 |
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