NEW YORK — Insulet Corporation is facing a securities class action alleging the company misled investors about its manufacturing controls before disclosing defects affecting millions of Omnipod insulin-delivery pods.
The lawsuit, filed in the U.S. District Court for the District of Massachusetts, covers investors who purchased Insulet securities between Feb. 21, 2025, and May 26, 2026.
According to the complaint, Insulet promoted the quality and scale of its manufacturing operations while failing to disclose alleged deficiencies at its Acton, Massachusetts, facility.
Company executives had told investors that Insulet was producing tens of millions of pods annually at medical-grade standards. Its regulatory filings also said the company inspected and tested products at several stages of the manufacturing process.
The lawsuit points to two voluntary Medical Device Corrections announced in 2026.
On March 12, Insulet issued a correction involving certain Omnipod 5 Pods after identifying a small tear in internal tubing used to deliver insulin. The company’s shares fell $16.23, or 6.9 percent, during the following trading session, the complaint said.
A second correction announced May 26 covered Omnipod 5, Omnipod Dash and older Omnipod Eros Pods. About 7 million pods were affected, representing approximately 8.5 percent of Insulet’s 2025 global production.
Insulet shares declined another $7.79, or 5.1 percent, following the second disclosure, according to the lawsuit.
Both corrective actions involved cannula tears associated with cannula handling at the company’s Acton facility.
The complaint alleges Insulet initially described the issue as affecting only a small number of pods and assured customers that products outside the identified lots remained safe to use. The later correction expanded the issue to millions of pods across several product lines.
The plaintiffs contend Insulet and certain executives knew, or recklessly disregarded, that the company’s manufacturing controls were deficient while making statements about product quality, safety and manufacturing efficiency.
The lawsuit seeks damages on behalf of affected shareholders. Investors seeking appointment as lead plaintiff have until Aug. 31, 2026, to file a motion with the court.
The allegations have not been proven, and Insulet’s response to the complaint was not included in the announcement.
