SAN FRANCISCO, July 7, 2026 /PRNewswire/ — National shareholder rights firm Hagens Berman Sobol Shapiro (HBSS) has launched an investigation into Medline Inc. (NASDAQ: MDLN) focusing on whether the company may have misled investors regarding the adequacy of its manufacturing quality controls and compliance with FDA safety standards.
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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.
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Medline Inc. (MDLN) Investigation:
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.
“We’re focused on whether Medline concealed from investors the serious concerns raised by the FDA,” said Reed Kathrein, the Hagens Berman partner leading the firm’s investigation.
If you invested in Medline and have substantial losses, or have knowledge that may assist the firm’s investigation, submit your losses now »
If you’d like more information and answers to other frequently asked questions about the Medline case and the firm’s investigation, read more »
Whistleblowers: Persons with non-public information regarding Medline should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new 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, call Reed Kathrein at 844-916-0895 or email MDLN@hbsslaw.com.
About Hagens Berman
Hagens Berman is a global plaintiffs’ rights complex litigation firm focusing on corporate accountability. The firm is home to a robust practice and represents investors as well as whistleblowers, workers, consumers and others in cases achieving real results for those harmed by corporate negligence and other wrongdoings. Hagens Berman’s team has secured more than $2.9 billion in this area of law. More about the firm and its successes can be found at hbsslaw.com. Follow the firm for updates and news at @ClassActionLaw.
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SOURCE Hagens Berman Sobol Shapiro LLP