FDA Drug Recall Report
pharmaranks analyzed 1,896 FDA drug recalls from Jan 2, 2024 to Sep 15, 2026.Here is what the data shows — how serious the recalls were, why drugs got pulled, and who recalled the most. All figures are computed directly from the U.S. FDA’s openFDA Enforcement database; nothing is estimated.
Recalls by year
By recall initiation date. Recalls rose 40% from 2024 to 2025. The current year is partial (data through Sep 15, 2026).
How serious were they? (FDA recall class)
The FDA grades every recall by risk. Class I is the most dangerous — a reasonable probability of serious harm or death.
May cause temporary or medically reversible harm; low probability of serious harm.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Most serious — a reasonable probability that use will cause serious harm or death.
Why drugs get recalled
Recall reasons, grouped from the FDA’s free-text reason field. "Manufacturing (CGMP) deviations" led with 565. Manufacturing and contamination problems alone account for 944 (50%).
Most-recalled manufacturers
Companies with the most recall events in the period (largely generic-drug makers). A high count reflects recall volume, not necessarily overall quality — large generics portfolios recall more.
The most serious recalls (Class I)
Recent Class I recalls — the FDA’s highest-risk tier.
- Superpotent DrugVITRUVIAS THERAPEUTICS INC · Aug 21, 2026
- Presence of Particulate Matter: identified as iron oxideB BRAUN MEDICAL INC · Aug 19, 2026
- Presence of particulate matter: Particulates identified as fiberglassBaxter Healthcare Corporation · Aug 17, 2026
- Presence of Particulate Matter: identified as stainless steel particles in the…Baxter Healthcare Corporation · Aug 17, 2026
- Presence of Particulate matter.B BRAUN MEDICAL INC · Aug 12, 2026
How fast the system responds — and who starts it
The lag from a firm initiating a recall to the FDA publishing it, and how many recalls are voluntary (firm-initiated) rather than FDA-ordered.
Nearly every U.S. drug recall in this data (100%) is voluntary — the manufacturer pulls the product itself, typically under FDA pressure, rather than being formally ordered to. Half reach the public record within 28 days of the firm acting (mean 33).
Methodology & sources
All figures are computed directly from the U.S. FDA’s openFDA drug Enforcement database (1,896 recall records initiated Jan 2, 2024–Sep 15, 2026, covering 385 manufacturers across 42states). Recall reasons are grouped by keyword from the FDA’s free-text field, so categories are approximate; counts by class, year, firm, and status are exact. Many recalls are still “ongoing,” so totals for recent periods will rise. Updated hourly from our live drug recall tracker.
Cite this report:“FDA Drug Recall Report,” pharmaranks, Sep 15, 2026. https://pharmaranks.com/recalls/report
For journalists & researchers: every figure here is derived from the open FDA enforcement dataset and is free to cite and reproduce with attribution and a link. For the methodology or a custom cut of the data, get in touch.