REGULATORY INTELLIGENCE·Recall
FDA Class II Recall: LEO Pharma's Adbry (tralokinumab-ldrm) Injection Faces Sterility Assurance Issues
LEO Pharma Inc. has initiated a nationwide Class II recall for 11,407 units of Adbry (tralokinumab-ldrm) injection due to a lack of sterility assurance. This voluntary action, prompted by wool fiber particulate matter in one unit, impacts lots 003E24C and 003E24A. Procurement and regulatory teams must assess supply chain vulnerabilities for injectable biologics and reinforce quality control protocols to mitigate similar contamination risks.
90-Day Activity
LEO PharmaADBRY
CMCatherine Morrow· Senior Regulatory Intelligence Analyst2026-03-04