Medline Faces FDA Warning Over Repeat *Bacillus cereus* Contamination in Drug Products

Medline has received a recent FDA warning letter over repeated bacterial contamination in its drug products, specifically tied to the presence of the toxic bacterium Bacillus cereus (B. cereus).

Between June 2023 and August 2025, Medline isolated B. cereus from finished drug products on about nine occasions, and also detected it in at least five environmental samples from its manufacturing facilities since January 2025.

FDA inspectors found that Medline failed to adequately investigate root causes or implement effective corrective actions, despite having raised the same issues in a prior inspection and in a May 2025 regulatory meeting with the company.

The agency noted that the same problematic manufacturing component or system has been identified as the root cause of the contamination in multiple investigations since 2023, and that similar quality control failures have occurred at several Medline facilities, signaling inadequate management oversight and control.

The FDA issued this warning letter after a 2025 inspection of Medline’s Waukegan, Illinois, drug‑manufacturing plant; the letter was dated May 28, 2026, and the regulator warned that persistent contamination and poor quality systems pose patient safety risks and may lead to further enforcement actions.