Food and drug safety

How many drug recalls are there each year?

The FDA classified 327 drug recalls in 2025, and between about 260 and 390 each year since 2013. Most are Class II, which could cause temporary or minor harm; 29 of 2025's were Class I, the most serious kind, which could cause serious harm or death. A recall counts once however many products, strengths or lots it covers, in the year FDA first listed it in its weekly Enforcement Report.

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Source and date

Data as of
Published

The data

Year FDA classified the recall Drug recalls
2013 341
2014 384
2015 259
2016 307
2017 340
2018 392
2019 350
2020 350
2021 291
2022 331
2023 291
2024 311
2025 327