Section 1291.330  Recalls and Product Safety

a)         Voluntary Recalls

1)         Each dispensing organization shall have policies and procedures governing voluntary recalls of cannabis products.

2)         All voluntary recall policies and procedures shall include the following at a minimum:

A)        A mechanism reasonably calculated to contact purchasers who have, or likely have, obtained the product from the dispensary, including information on the policy for return of the recalled product.  This may include outreach via media, as necessary and appropriate;

B)        A mechanism to identify and contact the adult use cultivation center, craft grower, or infuser that manufactured the cannabis;

C)        Policies for communicating with the Department, the Department of Agriculture, and the Department of Public Health within 24 hours of discovering defective or potentially defective cannabis;

D)        Policies for the collection of recalled product;

E)        Policies for destruction of any recalled cannabis product that comply with Section 1291.325; and

F)         Entry of recalled product into the State Verification System prior to destruction.  (Section 15-65 of the Act)

3)         Voluntary recalls may be initiated at any time as determined by the dispensing organization.

b)         Mandatory Recalls

1)         The Department may require dispensing organizations to conduct a recall of a cannabis product that is adulterated, misbranded, or otherwise poses a danger to public safety.

2)         The dispensing organization shall maintain policies and procedures for a mandatory recall that shall include, at a minimum:

A)        A mechanism reasonably calculated to contact purchasers who have, or likely have, obtained the product from the dispensary, including information on the policy for return of the recalled product.  This may include outreach via media, as necessary and appropriate;

B)        A mechanism to identify and contact the adult use cultivation enter, craft grower, or infuser that manufactured the cannabis;

C)        Policies for communicating with the Department, the department of Agriculture, and the Department of Public Health within 24 hours of discovering defective or potentially defective cannabis;

D)        Policies for the collection of recalled product;

E)        Policies for destruction of any recalled cannabis product that comply with Section 1291.325; and

F)         Entry of recalled product into the State Verification System prior to destruction.  (Section 15-65 of the Act)

3)         The Department may issue a mandatory recall and require dispensing organizations to immediately cease distribution of a cannabis product and recall the cannabis if the Department determines both of the following:

A)        The cultivation, manufacture, distribution, or sale of the cannabis or cannabis product creates or poses an immediate and serious threat to human life or health; and

B)        A recall is necessary to ensure the health and safety of affected cannabis consumers.

4)         The Department may require a dispensing organization to quarantine product without destruction for a minimum of 72 hours or until further notice of the Department, whichever occurs later, if the Department suspects the product is adulterated, misbranded, or otherwise poses a danger to public safety.

5)         The Department may require a dispensing organization to submit cannabis product that is suspected to be adulterated, defective, misbranded, or otherwise poses a danger to public safety to laboratory testing from a testing laboratory approved by the Illinois Department of Agriculture.  If the laboratory testing demonstrates the cannabis product is safe for consumption the Department may approve the dispensing organization to move the product back into active stock.

A)        For the purposes of this Section, "adulterated" shall include, but is not limited to, cannabis that has been tampered with by having the tamper-proof seal broken, cannabis that has been altered after it has been packaged, or cannabis that has materially changed condition since laboratory testing.

B)        For the purposes of this Section, "defective" shall have the same meaning as in Section 1291.60.

6)         In ordering a mandatory recall of cannabis pursuant to this Section, the director of the Department shall issue an order to that effect, which shall also include affidavits sufficient to lay out the factual basis for the recall.

7)         Whenever the Department issues a mandatory recall, an affected dispensing organization may file a request for hearing within 30 days of the recall.  All requests for hearing and any associated proceedings shall follow the rules of Practice in Administrative Hearings at 68 Ill. Adm. Code 1110.

A)        In the event a dispensing organization files a request for hearing, a formal hearing shall begin within 30 days of the filing of the request and shall be completed without appreciable delay.

B)        The Department shall bear the burden of proving the recalled cannabis is defective, adulterated, misbranded, or otherwise poses a danger to public safety.

(Source:  Added at 48 Ill. Reg. 13377, effective August 20, 2024)