Drug recalls, by the numbers
openFDA holds 18,076 drug recall records since 2012. 206 were reported in the last 90 days, 19 of them Class I, the category for products with a reasonable probability of serious harm.
Not health advice. GxRadar is for general information only. Nothing here is medical, pharmacy, legal or financial advice. Do not start, stop or change any medicine based on this site. Talk to your pharmacist or prescriber about your own situation.
Recall records per year
by FDA classShow as table
| Year | Class I | Class II | Class III |
|---|---|---|---|
| 2012 | 19 | 349 | 66 |
| 2013 | 71 | 1147 | 159 |
| 2014 | 152 | 1258 | 152 |
| 2015 | 105 | 1780 | 135 |
| 2016 | 130 | 963 | 161 |
| 2017 | 66 | 827 | 180 |
| 2018 | 107 | 1166 | 153 |
| 2019 | 511 | 1497 | 144 |
| 2020 | 109 | 824 | 102 |
| 2021 | 135 | 779 | 102 |
| 2022 | 88 | 1167 | 94 |
| 2023 | 67 | 1096 | 89 |
| 2024 | 106 | 483 | 68 |
| 2025 | 49 | 655 | 61 |
| 2026 | 38 | 611 | 54 |
Reasons, 2012–2026
Show as table
| Reason | Records |
|---|---|
| Sterility / contamination | 9273 |
| cGMP deviations | 2299 |
| Labeling or packaging error | 1906 |
| Impurities (e.g. nitrosamines) | 1369 |
| Other | 1021 |
| Potency out of spec | 723 |
| Undeclared or unapproved ingredient | 556 |
| Failed specifications (other) | 521 |
| Dissolution failure | 408 |
Serious risk
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Temporary or reversible risk
Use may cause temporary or medically reversible problems, or serious harm is remote.
Unlikely to cause harm
A violation of FDA rules that is not likely to cause adverse health consequences, such as some labeling errors.
Latest recall records
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Source: FDA Enforcement Report via openFDA. Product text is shortened and firm names are omitted; follow the recall number on FDA's site for the full record · data as of 2026-10-28. Figures can change and may contain errors in the source data. Check the original source before relying on them.
Recalls apply to specific lots. Check the lot number on your package with your pharmacist before taking any action, and do not stop a prescribed medicine without talking to your prescriber.