Medline Inc. (MDLN) Investigation

The firm is looking into whether Medline concealed systemic lapses in its contamination protocols—specifically failures to investigate microbial incidents and batch discrepancies—that prompted regulatory scrutiny and triggered a significant decline in the company’s share price.

Since Medline went public in December 2025, it has assured investors that “[w]e are committed to delivering products of the highest standard, which is reflected by our robust quality team of over 2,400 employees[]” and “[t]heir expertise ensures that every product bearing the Medline brand meets both our rigorous quality standards and our customers’ expectations[.]”

The effectiveness of the company’s quality team first came into question on June 2, 2026, when the FDA published its May 28 warning letter addressed to CEO Boyle. The FDA recited specific CGMP violations and said “your drug products are adulterated[.]”

The FDA highlighted the following deficiencies:

• “Between June 2, 2023 and August 27, 2025, your firm isolated objectionable microorganisms […] from finished drug product samples on approximately nine occasions[;]”
• “You also recovered [the objectionable microorganisms] in at least five samples taken from your manufacturing environment since January 2025[;]”
• “You failed to adequately investigate and implement corrective actions and preventative actions (CAPA) to determine root causes and prevent recurrence of these repeated contamination incidents[;]” and
• “This issue was cited on the previous Form FDA 483 issued to your firm in January 2025 and subsequently discussed during the most recent regulatory meeting held with your firm in May 2025.”

Investors also learned for the first time the next day that, as a result of the quality problems, Medline had shut down certain problematic facilities last October.

The market’s significantly negative reaction to these revelations erased about $2.2 billion from Medline’s market capitalization.

FREQUENTLY ASKED QUESTIONS ABOUT THE CASE

What is the MDLN investigation about?

We are focused on whether Medline concealed from investors the serious concerns raised by the FDA.

WHAT SHOULD I DO?

I worked at MDLN. What should I do?

If you were an employee of MDLN, you may have valuable information that could be relevant to the investigation. Hagens Berman is one of the nation’s top whistleblower law firms, and has successfully represented many individuals who come forward with information regarding corporate malfeasance. Under the new SEC Whistleblower program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, contact Reed Kathrein at 844-916-0895 or [email protected].

There are multiple law firms participating, do I need to contact all of them?

No, you do not need to contact all participating law firms. Generally, class-action investigations and lawsuits are consolidated into a single case to streamline the legal process, and attorneys from only a few law firms are selected to serve in a leadership role on the consolidated case. Hagens Berman has a proven track record of being appointed to leadership roles in complex, multidistrict litigation regarding investor fraud and other consumer rights issues, and your claim will be handled by attorneys who have helped secure approximately $325 billion in class-action settlements on behalf of individuals who have suffered due to corporate malfeasance and the wrongdoing of other powerful institutions.

AM I ELIGIBLE?

What is the threshold amount to be eligible? What are “substantial” losses?

The threshold amount and the definition of "substantial" losses may vary depending on a number of factors specific to the case, including the size of the company, market cap, shares outstanding and who holds them and the damages alleged by the fraud. In general, to be eligible to participate in a class-action lawsuit, you must be able to demonstrate that you suffered financial losses as a result of the alleged wrongdoing and that your losses meet the criteria set by the court or law firm. Fill out the form and submit your losses.

CAN I PARTICIPATE?

Am I affected? What do I need to do to participate?

If you were an investor in MDLN, you may be affected and eligible to participate in the case. To determine your eligibility and potential involvement, fill out the form and submit your losses.

Can any MDLN investor participate?

In most class-action investigations and cases, any investor who meets the eligibility criteria, including purchasing the shares during the relevant period, can participate, regardless of the size of their investment. Fill out the form to find out your rights.

I bought on a non-U.S. Exchange. Can I participate?

No. This investigation only covers shares bought on a U.S. exchange, i.e. NASDAQ or NYSE. Fill out the form to find out your rights.

Am I included if I still hold my shares, or do I need to sell to participate?

Participation is based on purchasing shares during the relevant period, rather than your current holdings. Accordingly, you do not need to sell to participate. Fill out the form to find out your rights.