--- kind: "section" citation: "21 U.S.C. § 364g" title: "21" title_heading: "Food and Drugs" number: "364g" heading: "Mandatory recall authority" release: "119-102" date: "2026-07-12" url: "https://uscodex.org/usc/21/364g" units: - "Chapter 9 — Federal Food, Drug, and Cosmetic Act" - "Subchapter VI — Cosmetics" --- # §364g. Mandatory recall authority - (a) **In general—** If the [Secretary](/usc/21/321.md?p=d) determines that there is a reasonable probability that a [cosmetic](/usc/21/321.md?p=i) is adulterated under [section 361 of this title](/usc/21/361.md) or misbranded under [section 362 of this title](/usc/21/362.md) and the use of or exposure to such [cosmetic](/usc/21/321.md?p=i) will cause serious adverse health consequences or death, the [Secretary](/usc/21/321.md?p=d) shall provide the [responsible person](/usc/21/364.md?p=4) with an opportunity to voluntarily cease [distribution](/usc/21/360eee.md?p=5) and recall such article. If the [responsible person](/usc/21/364.md?p=4) refuses to or does not voluntarily cease [distribution](/usc/21/360eee.md?p=5) or recall such [cosmetic](/usc/21/321.md?p=i) within the time and manner prescribed by the [Secretary](/usc/21/321.md?p=d) (if so prescribed), the [Secretary](/usc/21/321.md?p=d) may, by order, require, as the [Secretary](/usc/21/321.md?p=d) determines necessary, such [person](/usc/21/321.md?p=e) to immediately cease [distribution](/usc/21/360eee.md?p=5) of such article. - (b) **Hearing—** The [Secretary](/usc/21/321.md?p=d) shall provide the [responsible person](/usc/21/364.md?p=4) who is subject to an order under [subsection (a)](#a) with an opportunity for an [informal hearing](/usc/21/321.md?p=x), to be held not later than 10 days after the date of issuance of the order, on whether adequate evidence exists to justify the order. - (c) **Order resolution—** After an order is issued according to the process under subsections [(a)](#a) and [(b)](#b), the [Secretary](/usc/21/321.md?p=d) shall, except as provided in [subsection (d)](#d)— - (1) vacate the order, if the [Secretary](/usc/21/321.md?p=d) determines that inadequate grounds exist to support the actions required by the order; - (2) continue the order ceasing [distribution](/usc/21/360eee.md?p=5) of the [cosmetic](/usc/21/321.md?p=i) until a date specified in such order; or - (3) amend the order to require a recall of the [cosmetic](/usc/21/321.md?p=i), including any requirements to notify appropriate [persons](/usc/21/321.md?p=e), a timetable for the recall to occur, and a schedule for updates to be provided to the [Secretary](/usc/21/321.md?p=d) regarding such recall. - (d) **Action following order—** Any [person](/usc/21/321.md?p=e) who is subject to an order pursuant to paragraph [(2)](#c-2) or [(3)](#c-3) of subsection (c) shall immediately cease [distribution](/usc/21/360eee.md?p=5) of or recall, as applicable, the [cosmetic](/usc/21/321.md?p=i) and provide notification as required by such order. - (e) **Notice to persons affected—** If the [Secretary](/usc/21/321.md?p=d) determines necessary, the [Secretary](/usc/21/321.md?p=d) may require the [person](/usc/21/321.md?p=e) subject to an order pursuant to [subsection (a)](#a) or an amended order pursuant to paragraph [(2)](#c-2) or [(3)](#c-3) of subsection (c) to provide either a notice of a recall order for, or an order to cease [distribution](/usc/21/360eee.md?p=5) of, such [cosmetic](/usc/21/321.md?p=i), as applicable, under this section to appropriate [persons](/usc/21/321.md?p=e), including [persons](/usc/21/321.md?p=e) who manufacture, [distribute](/usc/21/360eee.md?p=5), import, or offer for sale such [product](/usc/21/360eee.md?p=13) that is the subject of an order and to the public. - (f) **Public notification—** In conducting a recall under this section, the [Secretary](/usc/21/321.md?p=d) shall— - (1) ensure that a press release is published regarding the recall, and that alerts and public notices are issued, as appropriate, in order to provide notification— - (A) of the recall to consumers and retailers to whom such [cosmetic](/usc/21/321.md?p=i) was, or may have been, distributed; and - (B) that includes, at a minimum— - (i) the name of the [cosmetic](/usc/21/321.md?p=i) subject to the recall; - (ii) a description of the risk associated with such article; and - (iii) to the extent practicable, information for consumers about similar [cosmetics](/usc/21/321.md?p=i) that are not affected by the recall; and - (2) ensure publication, as appropriate, on the website of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration of an image of the [cosmetic](/usc/21/321.md?p=i) that is the subject of the press release described in [paragraph (1)](#f-1), if available. - (g) **No delegation—** The authority conferred by this section to order a recall or vacate a recall order shall not be delegated to any officer or employee other than the [Commissioner](/usc/21/321.md?p=ee). - (h) **Effect—** Nothing in this section shall affect the authority of the [Secretary](/usc/21/321.md?p=d) to request or participate in a voluntary recall, or to issue an order to cease [distribution](/usc/21/360eee.md?p=5) or to recall under any other provision of this subchapter. ## Source credit (June 25, 1938, ch. 675, § 611, as added Pub. L. 117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136 Stat. 5855.) ## Notes ### Statutory Notes and Related Subsidiaries ### Construction; Confidentiality Nothing in section 3502 of Pub. L. 117–328, which enacted this section, to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title.