What licensees need to know about cannabis recalls

Cannabis recalls remove adulterated or misbranded cannabis goods from the licensed market. Licensees must act when they discover an affected cannabis good or receive a recall notice from the Department of Cannabis Control (DCC). This page explains how to prepare for and respond to a recall, including track and trace holds, remediation and destruction.

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Overview

DCC announces cannabis recalls to quickly remove cannabis and cannabis products, otherwise referred to as cannabis goods, from the licensed market when they do not meet standards established by the Medicinal and Adult Use Cannabis Regulation and Safety Act (MAUCRSA) and DCC regulations.

Recalls begin when a licensee discovers or is notified by DCC that a cannabis good is adulterated or misbranded. When DCC has evidence that a cannabis good is adulterated or misbranded, DCC will notify the designated responsible party (DRP) listed in the license record in accordance with Business and Professions Code (BPC) section 26039.1, subdivision (a). Regardless of whether the licensee discovers the adulterated or misbranded cannabis good, or they receive a Notice of Adulterated or Misbranded Cannabis Goods (recall notice) from DCC, the licensee must immediately implement their written recall procedures.

Establishing recall procedures

Pursuant to California Code of Regulations (CCR), title 4, section 17226, licensees must establish written procedures for recalling misbranded or adulterated cannabis and cannabis products, otherwise referred to as affected cannabis goods. The recall procedures must be implemented when the licensee discovers an affected cannabis good or receives a recall notice from DCC.

Recall procedures must include the following:

1. Factors requiring a recall
2. Personnel responsible for implementing recall procedures
3. Notification protocols, including:
   • A mechanism to notify all customers, including communication and outreach via media as necessary and appropriate
   • A mechanism to notify any licensees who supplied or received the recalled cannabis goods
   • Instructions to the public for returning or destroying the recalled cannabis goods
4. Procedures for collecting and destroying any recalled cannabis goods

Reasons cannabis goods are considered misbranded

Cannabis goods are considered misbranded for the following reasons, including but not limited to:

• The label is false or misleading
• The cannabis good was cultivated, processed, manufactured, packaged, or held in a location that is not properly licensed
• The product, packaging or labeling is attractive to people under 21 years of age
• The labeling or packaging does not comply with regulations (for example, missing allergens or serving instructions)

More information about misbranded cannabis goods can be found in BPC section 26039.5.

Reasons cannabis goods are considered adulterated

Cannabis goods are considered adulterated for the following reasons, including but not limited to:

• It tests positive for a prohibited species of Aspergillus
• It exceeds the regulatory limits for pesticide or residual solvents
• It was produced in unsanitary conditions
• It contains a harmful or restricted substance, such as synthetic cannabinoids or prohibited ingredients
• The actual amount of terpenoids, total THC or total CBD is different from what’s listed on the label, or is higher than the amount permitted in consumer products
• The type of product is prohibited from being sold in the licensed cannabis market
• The methods, facilities, or controls during cultivation, manufacture, packing, or holding that do not conform to, or are not operated or administered in conformity with DCC regulations, for example, being produced without good manufacturing practices
• It was mixed with or additional ingredients were substituted after regulatory compliance testing

More information about adulterated cannabis goods can be found in BPC section 26039.6.

Voluntary recall process

When a licensee discovers an adulterated or misbranded cannabis good, the licensee must immediately implement their written recall procedures and may issue a voluntary recall. Licensees must notify DCC of any recall within 24 hours of initiating the recall by emailing recalls@cannabis.ca.gov.

When DCC has evidence that a cannabis good is adulterated or misbranded, a recall notice will be sent to the DRP’s email address listed in the record of the responsible license. Upon receiving a recall notice from DCC, the licensee must immediately implement their written recall procedures and initiate a voluntary recall.

Once a voluntary recall is initiated, DCC will assist with removing the recalled cannabis good from the market by posting a public notice on the Recalls Portal and social media platforms and issuing a consumer advisory via email.

Responding to a recall notice

The DRP must respond to the recall notice within the stated timeframe and send their response from their email address listed in the license record. The response must include all of the following:

• Any information or documentation requested in the recall notice
• The licensee’s written recall procedures
• The notifications the licensee will distribute to the public, customers, licenses, and if necessary, media

The notifications must identify the recalled cannabis goods and provide instructions on how to properly destroy or return them.  

Failing to respond to a recall notice within the stated timeline or failing to implement the required voluntary recall procedures may result in a citation, fines, an order to abate, or other compliance and administrative actions, and lead to DCC issuing a mandatory recall.

Mandatory recall process

Pursuant to BPC section 26039.1, DCC may issue a mandatory recall and require the licensee to immediately cease distribution of the recalled goods when all of the following apply:

• The cultivation, manufacture, distribution, or sale of the goods creates or poses an immediate and serious threat to human life or health.
• Other available procedures would result in unreasonable delays.

DCC may also issue a mandatory recall if a licensee refuses to initiate a voluntary recall and the above criteria are met. DCC will determine whether a mandatory recall is warranted on a case-by-case basis and may order movement, segregation, isolation, or destruction of the recalled cannabis goods.

Informal hearing after a mandatory recall

When DCC issues a mandatory recall, the licensee is provided with an opportunity for an informal hearing. An informal hearing allows the licensee to object to the mandatory recall; address required actions and explain why the cannabis goods should not be recalled. The licensee must request an informal hearing within five days of the date DCC issued the mandatory recall.

Following the informal hearing, the mandatory recall may be affirmed, modified, or set aside by DCC. If the mandatory recall is affirmed, DCC will issue a Notice to Affirm Mandatory Recall Order explaining the licensee’s options which may include:

• Arranging for destruction of the recalled cannabis goods at the responsible licensee’s premises or another licensed premises
• Transferring the recalled cannabis goods to the responsible licensee’s premises, or an approved manufacturing premises for remediation in accordance with a DCC-approved corrective action plan
• Transferring the recalled cannabis goods to the responsible licensee’s premises and DCC initiating a condemnation proceeding in accordance with BPC section 26039.3, subdivision (f).

If necessary, DCC may conduct the mandatory recall and seek reimbursement for associated costs. Additional information is available in BPC section 26039.1.

Track and trace system hold

Pursuant to BPC section 26039.5 and BPC section 26039.6, it is unlawful to cultivate, process, manufacture, sell, deliver, hold, or offer for sale a cannabis good that is misbranded or adulterated. When DCC has evidence that a cannabis good is adulterated or misbranded, otherwise referred to as an affected cannabis good, or a cannabis good is recalled, a hold is immediately placed on the goods in the track and trace system. The hold is applied to the batch unique identifier (UID) number associated with the affected or recalled cannabis good and all packages derived from that batch.

The track and trace system sends an automated email notification to all licensees with the affected or recalled cannabis good in their track and trace inventory. When licensees receive a hold notification, they must immediately implement their quarantine protocols to ensure the affected or recalled cannabis good is not transferred or sold.

Once the hold is in place, either the license conducting the recall or DCC will communicate instructions for returning or destroying the recalled cannabis good. If the track and trace hold is released before instructions are received, the licensee must contact recalls@cannabis.ca.gov to obtain written approval before transferring or selling the recalled cannabis good.

Licensees who transfer or sell the recalled cannabis good after the DCC recall publication date stated on the Recalls Portal webpage or otherwise transfer or sell misbranded or adulterated cannabis goods, are subject to disciplinary action.

Remediating recalled cannabis goods

DCC may allow remediation of recalled cannabis goods on a case-by-case basis after reviewing and approving a corrective action plan. The licensee that will perform the remediation may use Form 17: Corrective Action Plan for Remediation to submit a corrective action plan to DCC for review.

Written approval of the plan must be obtained from DCC prior to beginning any remediation, reprocessing, repackaging, relabeling, reformulation, or modification of the cannabis goods.

For questions on remediation or to submit a corrective action plan, please contact remediation@cannabis.ca.gov.

Condemnation proceeding

If DCC denies the corrective action plan and the cannabis goods cannot otherwise be remediated, and the licensee refuses to destroy the recalled cannabis, DCC will initiate a condemnation proceeding in accordance with BPC section 26039.3 , subdivision (f).

A condemnation proceeding is a formal hearing held before an administrative law judge (judge) from the Office of Administrative Hearings (OAH). The scheduling and timing for the hearing is solely determined by OAH’s availability.

When a condemnation proceeding is initiated, the recalled cannabis good must be returned to the premises of the licensee who received the recall notice and DCC will immediately embargo the cannabis good to prevent their transfer or sale. The cannabis goods must remain embargoed for the entire duration of the condemnation proceeding. During the hearing, the judge will determine whether the cannabis goods are adulterated or misbranded.

If the judge determines the cannabis goods are adulterated or misbranded and cannot be corrected by proper labeling or additional processing, the judge may order the destruction of the cannabis goods under the supervision of DCC and at the licensee’s expense. The licensee will also be ordered to pay fees and reasonable costs, including the costs of storage, testing, and supervision, incurred by DCC in investigating and prosecuting the action taken.

If the judge determines the cannabis goods can be corrected by proper labeling or additional processing in compliance with MAUCRSA, the judge may direct the cannabis goods to be brought into compliance under DCC’s supervision. The licensee will be ordered to pay fees and reasonable costs, including the costs of storage, testing, and supervision incurred by DCC in investigating and prosecuting the action. DCC will release the embargo and supervise the corrective action only after the costs, fees, and expenses have been paid.

Destroying recalled cannabis goods

Pursuant to CCR section 17226, recalled cannabis goods that are intended to be destroyed must be quarantined for a minimum of 72 hours, unless a longer holding time is requested by DCC. The licensee must affix to the recalled cannabis good any bills of lading, shipping manifests, or other similar documents identifying the cannabis good’s information and weight. The cannabis goods held in quarantine will be subject to auditing by DCC. Following the quarantine period, the licensee must destroy the recalled cannabis goods under video surveillance and dispose of them in accordance with CCR section 17223.

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