Why are drugs recalled?

The most common reason in the 4,274 drug recalls the FDA classified from 2013 through 2025 was “not made under good manufacturing practices”: 673 recalls, about 16%. Next come “impurities or contamination” (542), “mix-ups and label errors” (504) and “can't be shown to be sterile” (495). 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.

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Source and date

Source
U.S. Food and Drug Administration, Enforcement Reports (openFDA drug recall data)
License
Public domain (U.S. government work); source U.S. Food and Drug Administration, openFDA
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 November 4, 2026).

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The data

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The file has the numbers in this table, with the source, license and date. Please credit the source and Chartly. Developers can also get them as JSON (how).

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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