Atlantic Biologicals Opioid DPA: DOJ Continues Ramp Up of Criminal Corporate Healthcare Enforcement

Overview of the Atlantic Biologicals DPA

On January 13, 2026, Miami-based pharmaceutical wholesaler Atlantic Biologicals Corporation entered into a two-year DPA, admitting to conspiracy to distribute and dispense controlled substances, including more than 14 million opioid doses to “pill mill” pharmacies in Texas at a markup. The DOJ and DEA underscored the company’s deliberate evasion of compliance checks and disregard for red flags signaling diversion.

The DPA includes a $450,000 criminal penalty, ongoing DOJ cooperation obligations, and mandatory implementation of a robust compliance and ethics program. The implicated business unit, National Apothecary Solutions (NAS), voluntarily ceased operations.

Five individuals involved in the wrongdoing also pled guilty to controlled substances offenses.

DOJ’s Considerations

• Admission of wrongdoing: Atlantic Biologicals acknowledged over $2.5 million in illicit proceeds and intent to supply for abuse/diversion.
• Remedial Actions and Business Changes: Significant credit was given to Atlantic Biologicals for its May 2023 voluntary cessation of sales of controlled substances to independently-owned pharmacies. The company also agreed to shut down the NAS business line that was central to the violations.
• No voluntary self-disclosure: DOJ noted that while Atlantic Biologicals ultimately cooperated, it did not initially self-disclose, which affected the terms of the resolution. However, the company did receive cooperation credit for factual presentations, organizing and producing voluminous records (including financial data), and facilitating the government's review of privileged and non-privileged materials.

Heightened Focus on Corporate Healthcare Prosecutions

This DPA is part of the DOJ larger trend of moving away from civil-only resolutions, and instead, leveraging criminal enforcement tools across the healthcare sector. The Department’s Criminal Fraud Section, which also covers other high-impact areas like the FCPA and trade and customs fraud, is increasingly focused on the systemic failures of corporate healthcare actors.

Notable recent corporate DPAs include Kimberly-Clark, resulting in a $40 million criminal penalty, and Avanos Medical, resulting in a $22 million criminal penalty, both in 2024. DOJ also entered into a non-prosecution agreement (NPA) in 2025 with Troy Health, resulting in a $1,430,008 criminal penalty. In 2023, DOJ declined prosecution, pursuant to DOJ’s Corporate Enforcement Policy, of HealthSun after considering several factors including HealthSun’s voluntary disclosure, cooperation, remediation, and $53 million repayment of overpayments to HHS. These cases have been brought by DOJ’s Healthcare Fraud Strike Force, which since its inception in 2007, has charged over 5,800 defendants for collective losses exceeding $30 billion.

Implications for Healthcare Clients

The DOJ has made clear that institutions, not just individual bad actors, are under scrutiny. The health care industry has always been heavily regulated, and DOJ has consistently prioritized enforcement of fraud against federally funded programs. The Healthcare Fraud Strike Force historically focused on criminally prosecuting individual bad actors but recently has shown an increased appetite to hold corporate bad actors responsible for conduct that may have previously been handled civilly. This puts companies at greater risk. The DOJ expects companies to have proactive, robust compliance programs and rigorous internal controls, especially around high-risk distribution or billing activities. Health care entities should also ensure they have proper reporting protocols in place, including monitoring for red flags and outlier conduct and providing paths for escalation, voluntary disclosure, and subsequent investigation. Following the identification of any improper conduct, companies should be sure to implement remedial measures, and carefully document those efforts, in case there is exposure or government inquiry. These companies should also carefully consider the possibility of voluntary self-disclosure.

Looking Ahead

DOJ's evolving enforcement strategy is here to stay, and companies can no longer expect that conduct once addressed more commonly through civil remedies will avoid criminal scrutiny. The risk of criminal prosecution for health care companies that do not have adequate compliance and oversight programs is growing. Past resolutions with companies like Kimberly-Clark and Avanos Medical, coupled with the Atlantic Biologicals DPA, send a clear signal that organizational compliance and governance must be prioritized.