Violation Tracker Agency Summary Page
Agency Name:
Food and Drug Administration
Penalty Total since 2000:
$19,512,069,130
Number of Records:
59
Note:
The parent penalty totals are adjusted to account for the fact that the list of individual entries below may include both agency records and settlement announcements for the same case; or else a penalty covering multiple locations may be listed in the individual records for each of the facilities. Duplicate penalty amounts are marked with an asterisk in the individual records list below.
| Top 10 Parent Companies | Total Penalty $ | Number of Records |
|---|---|---|
| GlaxoSmithKline | $3,750,000,000 | 2 |
| Pfizer | $3,320,400,000 | 6 |
| AbbVie | $2,430,500,000 | 5 |
| Johnson & Johnson | $2,392,200,000 | 5 |
| Eli Lilly | $1,451,000,000 | 2 |
| Merck | $950,000,000 | 1 |
| Amgen | $762,000,000 | 1 |
| Merck KGaA (EMD) | $704,000,000 | 1 |
| AstraZeneca | $520,000,000 | 1 |
| Sun Pharmaceuticals | $500,000,000 | 1 |
Individual Penalty Records:
Click on the company or penalty amount for more information on each case. Click on the parent name to reach the summary page for that parent company.
| Company | Parent | Parent Major Industry | Primary Offense Type |
Year |
Penalty Amount |
|---|---|---|---|---|---|
| Wyeth-Ayerst Laboratories Division | Pfizer | pharmaceuticals | drug or medical equipment safety violation | 2000 | $30,000,000 |
| Warner-Lambert | Pfizer | pharmaceuticals | off-label or unapproved promotion of medical products | 2004 | $430,000,000 |
| Serono, S.A. | Merck KGaA (EMD) | pharmaceuticals | off-label or unapproved promotion of medical products | 2005 | $704,000,000 |
| Eli Lilly and Company | Eli Lilly | pharmaceuticals | off-label or unapproved promotion of medical products | 2005 | $36,000,000 |
| InterMune Inc. | Roche | pharmaceuticals | off-label or unapproved promotion of medical products | 2006 | $36,900,000 |
| Cell Therapeutics Inc. | off-label or unapproved promotion of medical products | 2007 | $10,500,000 | ||
| Cephalon Inc | Teva Pharmaceutical Industries | pharmaceuticals | off-label or unapproved promotion of medical products | 2008 | $425,000,000 |
| Otsuka American Pharmaceutical Inc. | Otsuka Pharmaceutical | pharmaceuticals | off-label or unapproved promotion of medical products | 2008 | $4,000,000 |
| True World Foods Chicago, LLC | environmental violation | 2008 | $60,000 | ||
| Spectranetics Corporation | Royal Philips | diversified | off-label or unapproved promotion of medical products | 2009 | $5,000,000 |
| Pfizer Inc. | Pfizer | pharmaceuticals | off-label or unapproved promotion of medical products | 2009 | $2,300,000,000 |
| Eli Lilly and Company | Eli Lilly | pharmaceuticals | off-label or unapproved promotion of medical products | 2009 | $1,415,000,000 |
| Elan Corporation PLC | Perrigo | pharmaceuticals | off-label or unapproved promotion of medical products | 2010 | $203,000,000 |
| Eisai Inc. | Eisai | pharmaceuticals | off-label or unapproved promotion of medical products | 2010 | $11,000,000 |
| SB Pharmco Puerto Rico Inc. | GlaxoSmithKline | pharmaceuticals | drug or medical equipment safety violation | 2010 | $750,000,000 |
| Novartis Pharmaceuticals Corporation | Novartis | pharmaceuticals | off-label or unapproved promotion of medical products | 2010 | $422,500,000 |
| Allergan Inc. | AbbVie | pharmaceuticals | off-label or unapproved promotion of medical products | 2010 | $600,000,000 |
| Ortho-McNeil Pharmaceutical LLC | Johnson & Johnson | pharmaceuticals | off-label or unapproved promotion of medical products | 2010 | $81,000,000 |
| AstraZeneca LP | AstraZeneca | pharmaceuticals | off-label or unapproved promotion of medical products | 2010 | $520,000,000 |
| Ethex Corporation | drug or medical equipment safety violation | 2010 | $27,600,000 | ||
| Kos Pharmaceuticals | AbbVie | pharmaceuticals | kickbacks and bribery | 2010 | $41,500,000 |
| Novartis Vaccines & Diagnostics Inc. and Novartis Pharmaceuticals Corporation | Novartis | pharmaceuticals | off-label or unapproved promotion of medical products | 2010 | $72,500,000 |
| Atricure Inc. | AtriCure | medical equipment and supplies | off-label or unapproved promotion of medical products | 2010 | $3,760,000 |
| Merck, Sharp & Dohme | Merck | pharmaceuticals | off-label or unapproved promotion of medical products | 2011 | $950,000,000 |
| Pfizer Inc. | Pfizer | pharmaceuticals | off-label or unapproved promotion of medical products | 2011 | $14,500,000 |
| Scios Inc. | Johnson & Johnson | pharmaceuticals | off-label or unapproved promotion of medical products | 2011 | $85,000,000 |
| Novo Nordisk Inc. | Novo Holdings A/S | pharmaceuticals | off-label or unapproved promotion of medical products | 2011 | $25,000,000 |
| UCB Inc. | UCB | pharmaceuticals | off-label or unapproved promotion of medical products | 2011 | $34,000,000 |
| Forest Pharmaceuticals Inc. | AbbVie | pharmaceuticals | off-label or unapproved promotion of medical products | 2011 | $164,000,000 |
| Guidant LLC | Boston Scientific Corp. | medical equipment and supplies | drug or medical equipment safety violation | 2011 | $296,000,000 |
| Medtronic Inc. | Medtronic | medical equipment and supplies | kickbacks and bribery | 2011 | $23,500,000 |
| Google Inc. | Alphabet Inc. | information technology | off-label or unapproved promotion of medical products | 2011 | $500,000,000 |
| Globus Medical Inc. | Globus Medical | medical equipment and supplies | off-label or unapproved promotion of medical products | 2012 | $550,000 |
| Pfizer Inc. | Pfizer | pharmaceuticals | drug or medical equipment safety violation | 2012 | $55,000,000 |
| GlaxoSmithKline LLC | GlaxoSmithKline | pharmaceuticals | off-label or unapproved promotion of medical products | 2012 | $3,000,000,000 |
| Abbott Laboratories Inc. | AbbVie | pharmaceuticals | off-label or unapproved promotion of medical products | 2012 | $1,500,000,000 |
| Cypress Pharmaceutical Inc. | Currax Pharmaceuticals | pharmaceuticals | off-label or unapproved promotion of medical products | 2012 | $2,800,000 |
| Amgen Inc. | Amgen | pharmaceuticals | off-label or unapproved promotion of medical products | 2012 | $762,000,000 |
| Healthpoint Ltd. and DFB Pharmaceuticals | off-label or unapproved promotion of medical products | 2012 | $28,000,000 | ||
| Boehringer Ingelheim Pharmaceuticals Inc. | Boehringer Ingelheim | pharmaceuticals | off-label or unapproved promotion of medical products | 2012 | $95,000,000 |
| Advanced Sterilization Products, a division of Ethicon Inc. | Johnson & Johnson | pharmaceuticals | drug or medical equipment safety violation | 2013 | $1,200,000 |
| Johnson & Johnson | Johnson & Johnson | pharmaceuticals | off-label or unapproved promotion of medical products | 2013 | $2,200,000,000 |
| Boston Scientific Corp. | Boston Scientific Corp. | medical equipment and supplies | drug or medical equipment safety violation | 2013 | $30,000,000 |
| Wyeth Pharmaceuticals Inc. | Pfizer | pharmaceuticals | off-label or unapproved promotion of medical products | 2013 | $490,900,000 |
| Par Pharmaceutical Companies Inc. | Endo International | pharmaceuticals | off-label or unapproved promotion of medical products | 2013 | $45,000,000 |
| Ranbaxy USA Inc. | Sun Pharmaceuticals | pharmaceuticals | drug or medical equipment safety violation | 2013 | $500,000,000 |
| OtisMed Corp. | Stryker | medical equipment and supplies | drug or medical equipment safety violation | 2014 | $79,560,000 |
| Endo Health Solutions Inc. | Endo International | pharmaceuticals | off-label or unapproved promotion of medical products | 2014 | $192,700,000 |
| Shire Pharmaceuticals LLC | Takeda Pharmaceutical | pharmaceuticals | off-label or unapproved promotion of medical products | 2014 | $56,500,000 |
| CareFusion Corp. | Becton Dickinson | medical equipment and supplies | False Claims Act and related | 2014 | $40,100,000 |
| Genzyme Corporation | Sanofi | pharmaceuticals | drug or medical equipment safety violation | 2015 | $32,587,439 |
| ConAgra Grocery Products LLC | ConAgra Brands | food products | food safety violation | 2015 | $11,200,000 |
| Quality Egg LLC | Quality Egg | food products | food safety violation | 2015 | $6,790,000 |
| McNeil-PPC Inc. | Johnson & Johnson | pharmaceuticals | drug or medical equipment safety violation | 2015 | $25,000,000 |
| Warner Chilcott PLC | AbbVie | pharmaceuticals | off-label or unapproved promotion of medical products | 2015 | $125,000,000 |
| B. Braun Medical Inc. | B. Braun Melsungen | medical equipment and supplies | drug or medical equipment safety violation | 2016 | $7,800,000 |
| Roos Foods Inc. | food safety violation | 2016 | $100,000 | ||
| GNC Holdings Inc. | Harbin Pharmaceutical Group | pharmaceuticals | drug or medical equipment safety violation | 2016 | $2,250,000 |
| SCM True Air Technologies, Inc. | drug or medical equipment safety violation | 2017 | $711,691 |
