21 U.S.C. § 364g — Mandatory recall authority

(a) In general: If the Secretary determines there is a reasonable probability that a cosmetic is adulterated under section 361 or misbranded under section 362, and that using or being exposed to it will cause serious health harm or death, the Secretary must first give the responsible person a chance to voluntarily stop distributing and recall it. If the responsible person refuses, or does not act within the time and manner the Secretary sets, the Secretary may order that person to immediately stop distributing the product. (b) Hearing: The responsible person subject to that order gets an informal hearing, held no later than 10 days after the order issues, on whether there is enough evidence to justify it. (c) Order resolution: After that hearing process, the Secretary must, unless (d) applies: (1) vacate the order if the grounds for it turn out to be inadequate; (2) keep the stop-distribution order in place until a specified date; or (3) amend the order into a recall, including requirements to notify the right people, a recall timetable, and a schedule of updates to the Secretary. (d) Action following order: Anyone subject to an order under (c)(2) or (c)(3) must immediately stop distributing, or recall, the cosmetic, and provide the notifications the order requires. (e) Notice to persons affected: If the Secretary decides it is necessary, the Secretary can require the person under the order to send a recall notice or stop-distribution notice to the right people, including manufacturers, distributors, importers, and sellers of the product, and to the public. (f) Public notification: While running a recall, the Secretary must (1) make sure a press release goes out and appropriate alerts and public notices are issued, telling consumers and retailers who received, or may have received, the cosmetic about the recall, including at minimum the product's name, a description of its risk, and, where practical, information about similar, unaffected products; and (2) make sure an image of the recalled product is published on the FDA's website alongside the press release, if available. (g) No delegation: Only the Commissioner personally, not any other officer or employee, can order a recall or vacate a recall order under this section. (h) Effect: This section does not limit the Secretary's authority to request or take part in a voluntary recall, or to issue a stop-distribution or recall order under any other part of this subchapter.