Drug Safety Statistics
Data and trends from 18,041 FDA drug recalls spanning 2006 to 2026.
Drug Recalls by Year
Number of FDA drug recall enforcement actions initiated per year.
Top Recall Reasons
Most common reasons for FDA drug recalls.
| # | Reason | Recalls |
|---|---|---|
| 1 | Lack of Sterility Assurance | 5,471 |
| 2 | cGMP Deviations | 3,978 |
| 3 | Contamination | 2,165 |
| 4 | Other | 1,899 |
| 5 | Labeling Errors | 1,452 |
| 6 | Foreign Particles | 726 |
| 7 | Impurities / Nitrosamines | 720 |
| 8 | Potency Issues | 643 |
| 9 | Stability / Out of Spec | 568 |
| 10 | Failed Dissolution | 409 |
| 11 | Cross-Contamination / Mix-up | 10 |
Top Recalling Firms
Companies with the most FDA drug recall actions.
| # | Firm | Recalls |
|---|---|---|
| 1 | Aidapak Services, LLC | 538 |
| 2 | Attix Pharmaceuticals | 470 |
| 3 | King Bio Inc. | 465 |
| 4 | The Compounding Pharmacy of America | 383 |
| 5 | Main Street Family Pharmacy, LLC | 299 |
| 6 | Pharmedium Services, LLC | 282 |
| 7 | Central Admixture Pharmacy Services, Inc. | 275 |
| 8 | Cardinal Health Inc. | 213 |
| 9 | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | 198 |
| 10 | Teva Pharmaceuticals USA | 196 |
| 11 | Akorn, Inc. | 176 |
| 12 | Dr. Reddy's Laboratories, Inc. | 163 |
| 13 | Mckesson Medical-Surgical Inc. Corporate Office | 157 |
| 14 | Glenmark Pharmaceuticals Inc., USA | 141 |
| 15 | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy | 140 |
Recalls by State
States where recalling firms are located.
| # | State | Recalls |
|---|---|---|
| 1 | New Jersey | 2,201 |
| 2 | Florida | 1,537 |
| 3 | Illinois | 1,357 |
| 4 | California | 1,120 |
| 5 | New York | 1,040 |
| 6 | Tennessee | 992 |
| 7 | Texas | 973 |
| 8 | North Carolina | 858 |
| 9 | Washington | 788 |
| 10 | Pennsylvania | 706 |
| 11 | Ohio | 630 |
| 12 | Arizona | 518 |
| 13 | Michigan | 451 |
| 14 | Virginia | 420 |
| 15 | N/A | 416 |
| 16 | Arkansas | 296 |
| 17 | Nevada | 233 |
| 18 | Indiana | 211 |
| 19 | Connecticut | 208 |
| 20 | Maryland | 182 |
About This Data
All drug recall data comes from the U.S. FDA through the openFDA enforcement database. Our database contains 18,041 drug recall enforcement actions spanning 2006 to 2026.
Class I is the most serious, reasonable probability of serious adverse health consequences or death. Class II means temporary or medically reversible adverse effects. Class III is least serious, exposure not likely to cause harm. Our database contains 1,749 Class I, 14,572 Class II, and 1,720 Class III.