FDA cosmetic recall guidance under MoCRA, final Q&A explained
FDA finalized its MoCRA cosmetic recall guidance on October 22, 2026. FDA must offer a voluntary recall before it can order one for serious-harm risk.
FDA cosmetic recall guidance under MoCRA, finalized
FDA finalized its cosmetic recall guidance under MoCRA on October 22, 2026. The final Q&A explains when FDA can order a recall under section 611 of the FD&C Act, after offering the company named on the label a voluntary recall opportunity.
The Federal Register notice (FR Doc. 2026-21679, docket FDA-2025-D-2246) publishes October 23, 2026. FDA received seven comments on the December 18, 2025 draft, called them "broadly supportive," and finalized the text with no substantive changes.
The guidance is non-binding. The duties sit in section 611, codified at 21 U.S.C. 364g, which MoCRA added on December 29, 2022. The final text explains that existing power.
When FDA can order a cosmetic recall
FDA must find a reasonable probability that the cosmetic is adulterated (section 601) or misbranded (section 602). It must also find a reasonable probability that use of or exposure to it "will cause serious adverse health consequences or death." The final guidance shortens that health test to "SAHCOD." Both findings are required, so a labeling problem without the health finding does not trigger an order.
Q9 and Q10 list adulteration and misbranding grounds. These include poisonous or filthy substances, insanitary conditions, unsafe color additives other than hair dye, and failure to meet applicable section 606 good manufacturing practice (GMP) requirements. A product or ingredient without adequate safety substantiation under section 608(c) is also adulterated. Misbranding includes false or misleading labeling, missing required label information and Poison Prevention Packaging Act violations.
For the health test, Q12 points to the section 604 list of serious adverse events. Examples include death, inpatient hospitalization, infection and significant disfigurement other than as intended, such as second- or third-degree burns or significant hair loss. Depending on the evidence, some of these "may represent a SAHCOD risk."
Q11 lists the evidence FDA may weigh. That includes inspection observations, test results on raw materials, finished product and environmental swabs, and epidemiological data showing people have already been hurt. FDA also looks at how vulnerable the users are (for example infants, toddlers, elderly people, pregnant women or medically compromised users), serious adverse event reports, consumer and trade complaints, and whether the firm already refused a voluntary recall.
Who is covered
Section 611 covers every article that meets the FD&C Act definition of a cosmetic. Soap is outside that definition. Products that are also drugs or devices are not subject to section 611, though other mandatory recall powers may apply (Q1 and Q2).
The order goes to the "responsible person": the manufacturer, packer or distributor whose name appears on the label (Q3).
The voluntary recall opportunity comes first
Q5 to Q8 explain the process:
- FDA tells the responsible person in writing that it has a chance to stop distribution and recall voluntarily. FDA sets the time and manner.
- If the firm refuses or misses that deadline, FDA can order it to cease distribution immediately.
- The firm gets an opportunity for an informal hearing under 21 CFR part 16. If FDA grants a hearing, it is held no later than 10 days after the date of issuance. It addresses whether adequate evidence justifies the order.
- FDA then vacates the order, continues it to a set date, or amends it to require a recall. A recall order includes notification duties, a timetable and a schedule for updates to FDA.
Only the Commissioner can order a recall or vacate a recall order. The statute says that power "shall not be delegated" (611(g)).
Under a recall order, FDA ensures a press release is published. It names the product, describes the risk and, where practical, identifies similar products that are not affected. FDA also posts a product image if one is available, and issues alerts (typically a notification letter or email) and public notices to consumers and retailers.
A continued cease-distribution order lasts until its specified date (Q14). A recall order generally ends when FDA finds every requirement met (Q15). FDA generally follows the 21 CFR 7.55 termination process, including written notice to the firm.
What happens if a company ignores the order
Refusing or failing to follow an order under section 611 (21 U.S.C. 364g) is a prohibited act under 21 U.S.C. 331(iii). Q16 says the firm "could be subject to injunction and/or criminal prosecution" under sections 302 and 303.
How this relates to Class I, II and III recalls
FDA expects most violative cosmetics to continue to be recalled voluntarily under 21 CFR part 7. Its cosmetics recall policy says a firm can start a recall itself or FDA can request one. FDA expects firms to notify the appropriate Office of Inspections and Investigations division, tell customers, report progress and check recall effectiveness. 21 CFR 7.53 says status reports generally come every 2 to 4 weeks.
FDA classifies recalls under 21 CFR 7.3(m):
| Class | Health risk |
|---|---|
| I | Reasonable probability of serious adverse health consequences or death |
| II | May cause temporary or medically reversible harm, or the probability of serious harm is remote |
| III | Not likely to cause adverse health consequences |
The section 611 health threshold uses the same words as the Class I definition. That overlap doesn't make every section 611 recall a Class I.
What to do now
Confirm whose name is on each label. Treat FDA's written opportunity to stop distribution and recall voluntarily as time-sensitive. Missing that deadline can lead to a cease-distribution order. If that order comes, stop distribution immediately. Decide promptly whether to seek a hearing: the 10 days run from the date of issuance (section 611). An amended recall order sets the notification duties, recall timetable and reporting schedule the firm must follow (section 611(c)).
Keep inspection findings, test results, adverse event records and complaints where the quality team can find them. Gaps in safety substantiation, or in section 606 GMP requirements, are adulteration grounds under Q9. Those records are evidence FDA may weigh under Q11.
You can ask RegAffairs AI about mandatory cosmetic recalls and open the cited sources.