Greenleaf released the following statement:
"Greenleaf Laboratories offers our sincere apology to our clients, partners, and regulators for the significant errors identified in the post-analysis data processing of Total Yeast and Mold (TYM) results. These errors––rooted in the implementation of a calculation change converting CQ to CFU/g––resulted in inaccurate Certificates of Analysis (CoAs) and confusion within the industry.
Between April 2023 to July 23, 2025, we had samples that had quantifiable TYM detections that failed to meet compliance standards. This sharply contrasts with our prior failure rate and we have taken immediate steps to get back into compliance. We deeply regret the disruption and loss of confidence this has caused.
Immediately upon identifying the issue, we acted in good faith to correct it––drafting a data recall procedure, validating calculations, and submitting the finalized recall to our LIMS vendor. Despite these efforts, technical execution of the recall was blocked by the vendor's refusal to assist.
We accept full responsibility for the oversight and its consequences. This week alone, we have incurred over $85,000 in lost revenue and anticipate an additional $450,000 in costs to cover third-party retesting for impacted businesses. We also intend to fully comply with and pay any fines assessed by OMMA.
In response, we have implemented the following corrective actions to ensure transparency, accuracy, and to prevent recurrence:
• Conducted internal SOP audits and an external vendor audit to ensure process integrity.
• Deployed updated quality control systems and software in the Micro Department to improve lot tracking and result reliability.
• Adopted all vendor-recommended SOP revisions (GL-MSOP-11) as of August 14.
• Implemented GL-SOP-28, a Vendor Communication Policy, to strengthen accountability and escalation protocols.
• Initiated full reimbursement for affected clients and are covering the cost of retesting through an independent lab (Abraxis).
In parallel, we are undergoing additional internal and external proficiency testing (PTs) for all safety analyses and will provide full documentation of validation and verification efforts upon completion.
We understand that trust must be earned through action. Our commitment to scientific integrity, regulatory compliance, and client trust is unwavering. We will continue to cooperate fully with OMMA and provide all necessary documentation for review prior to public release of recall information. It is our intention when approved to issue a public statement on the recall of data, along with the full list of impacted samples.
Again, we extend our deepest apologies to all those impacted."