Once the FDA has determined that the criteria for a mandatory recall have been met, the FDA must first provide the responsible party (as defined in section 417(a)(1) of the FD&C Act) with an opportunity to voluntarily cease distribution and recall the article of food. The FDA will notify the responsible party of this opportunity in writing using an expeditious method of delivery. If the responsible party refuses or does not voluntarily cease distribution and recall the article of food within the time and manner prescribed by the FDA, if so prescribed, the FDA may order the responsible party to cease distributing the article of food, order the responsible party to give notice to certain other persons to cease distributing the article of food, and give the responsible party an opportunity to request an informal hearing2 to be held not later than 2 days after the issuance of the order. After these steps are completed, the FDA may order a recall under section 423(d) of the FD&C Act if it is determined that the removal of the article from commerce is necessary. Only the FDA Commissioner has the authority to order a recall under section 423(d). If necessary, recall orders under section 423(d) shall be vacated by the Commissioner. If the FDA orders a recall under section 423 of the FD&C Act, the FDA will generally follow the process for termination of the recall in accordance with 21 C.F.R. 7.55.

https://www.fda.gov/media/117429/download#:~:text=Section 423 of the FD%26C,the FD%26C Act [21 U.S.C.

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