Ensuring Patient Safety: Ohio’s Recall Procedures for Medical Marijuana

Ohio’s medical cannabis market is strictly regulated by the Ohio Department of Commerce and the Board of Pharmacy under the Medical Marijuana Control Program (MMCP). When a distributor or licensed processor identifies a product that may pose a risk to safety or compliance, the state has a structured recall process to protect patients.

Detection and Reporting of Non‑Compliance

Product recalls typically begin when testing reveals non-conformance—such as microbial contamination, foreign material, or incomplete testing. Licensed labs run robust analyses for yeast, mold, heavy metals, microbials, and other contaminants. If a batch fails, the processor (or distributor) must report it to the MMCP immediately. In recent recalls—e.g., the Pure Ohio Wellness recall in March 2020—the state intervened when plant material lacked complete safety testing.

Issuing the Recall Notice

Following identification, the MMCP (under the Department of Commerce or Board of Pharmacy) issues a recall notice to all affected entities. These notices describe the affected product (strain, batch number, dates of distribution) and categorize risk (mandatory vs. voluntary). For example, the Galenas LLC Blueberry Cookies recall was prompted when dispensaries discovered plastic fragments in packaging, triggering a mandatory recall of specific lots.

Product Quarantine and Removal

Upon notification, distributors must immediately quarantine the non-compliant inventory—ideally by the next business day—and prevent further distribution until the product is either destroyed or returned. Distributors follow detailed internal procedures, including written records of all actions taken, to remain compliant with Ohio Administrative Code 3796‑6‑3‑14 and Code 3796‑6‑3‑20.

Consumer and Patient Notification

Ohio allows discretion regarding patient-level notification. Distributors and dispensaries determine whether consumers should be informed based on the product’s risk. If necessary, they notify impacted patients or caregivers directly. Regardless, MMCP requires that returned products not count against a patient’s 90-day limit.

Product Return and Destruction

Affected products must be returned to the originating dispensary or distributor. These items are then destroyed or rendered non-retrievable in compliance with state-approved removal processes. Disposal protocols require grinding and mixing with non-cannabis waste and must be witnessed by at least two employees under surveillance; documentation must be retained for at least three years.

Documentation and Follow‑Up

Ohio law mandates meticulous documentation for recall events: inventory removal logs, destruction records, communication logs with MMCP, and copies of recall notices. These records must be retained for a minimum of three years. Ohio regulators may audit or inspect distributors to verify corrective actions. Non-compliance can result in fines or suspension of licensing privileges.

Extended Oversight and Investigation

In significant incidents—such as the Green Investment Partners Tangie Power recall in December 2022—state regulators may initiate formal investigations and publish executive summaries detailing corrective measures taken.

Overall, Ohio’s approach ensures safety and transparency across all levels—testing, distribution, dispensing, and destruction. This robust system includes:

  • Immediate quarantine of non-compliant batches
  • Risk assessment followed by patient-level notification
  • Documented product return and disposal
  • Mandatory record-keeping and regulatory oversight