Prescription drugs with the most FDA recalls (2026 data)
Ask ChatGPT "which prescription drugs have been recalled the most?" and it will tell you the FDA doesn't publish a leaderboard. We built one from the FDA's own enforcement data — counting recall events per FDA application so a drug sold in several presentations counts once.
Prescription drugs with the most FDA recall events
| Rank | Drug | Active ingredient | FDA recall events |
|---|---|---|---|
| 1 | Daytrana | Methylphenidate | 42 |
| 2 | Tirosint-Sol | Levothyroxine Sodium | 15 |
| 3 | Minivelle | Estradiol | 10 |
| 4 | Epipen E Z Pen | Epinephrine | 7 |
| 5 | Epipen | Epinephrine | 7 |
| 6 | Epi E Z Pen Jr | Epinephrine | 7 |
| 7 | Epipen Jr. | Epinephrine | 7 |
| 8 | Ativan | Lorazepam | 6 |
| 9 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | 6 |
| 10 | Marcaine Hydrochloride W/ Epinephrine | Bupivacaine Hydrochloride | 5 |
| 11 | Marcaine Hydrochloride W/ Epinephrine Preservative Free | Bupivacaine Hydrochloride | 5 |
| 12 | Paxil Cr | Paroxetine Hydrochloride | 5 |
| 13 | Marcaine Hydrochloride | Bupivacaine Hydrochloride | 5 |
| 14 | Spiriva | Tiotropium Bromide | 5 |
| 15 | Marcaine Hydrochloride Preservative Free | Bupivacaine Hydrochloride | 5 |
What this means
At the top is Daytrana (Methylphenidate) with 42 recorded FDA recall events. A high recall count does not mean a drug is dangerous to take — most recalls are driven by manufacturing, contamination, potency, labeling, or packaging issues, and every recalled lot is removed from the market. Widely-used drugs made in huge volumes naturally accumulate more recall events.
How we built this
We matched each product to its FDA application number, counted recall events in the FDA enforcement (openFDA) database, and ranked by total events. Counting per application avoids double-counting the same drug sold as multiple presentations.
Not medical advice. If you take any of these medicines, don't stop based on this page — your specific lot was almost certainly never recalled. Check the FDA recall database or talk to your pharmacist. Each drug's page on pharmaranks shows its recall-adjusted safety score and full details.
Generated live from the pharmaranks database (FDA openFDA enforcement data) at publication time.
This article is for general education and is not medical advice. Consult a licensed professional for guidance about your health.