This morning the FDA announced release of its final guidance on mandatory cosmetic recalls. It’s a short question-and-answer document that explains how the FDA will use the recall authority it was given under MoCRA. The draft came out in December 2025; the final version is now official.
Before MoCRA, the FDA couldn’t order a cosmetic recall. It could only ask. Now it can order one, but only in limited circumstances. And the FDA says it expects most recalls to continue to be voluntary, just as they always have been.
You can read the full guidance here: Questions and Answers Regarding Mandatory Cosmetics Recalls.
What It Covers
The recall authority applies to any type of cosmetic. Products that aren’t cosmetics (including soap that isn’t a cosmetic) aren’t included and products that are both a cosmetic and a drug (such as sunscreens or antiperspirants) are covered under a different recall authority.
The Responsible Person
The recall provisions apply to the responsible person. Under MoCRA, that’s the manufacturer, packer or distributor whose name appears on the label.
If your business name is on the label, that’s you. If someone else makes a product for you and it goes out under your name, it’s still you.
There’s no small business exemption here. MoCRA’s small business exemptions cover facility registration, product listing and the (still upcoming) GMP regulations, but not recalls. That’s not cause for alarm. It just means the same rules apply to everyone.
How a Problem Gets Noticed
A recall doesn’t come out of nowhere. Typically something brings a product to the FDA’s attention first: consumer complaints, a report of a serious adverse event (which responsible persons are required to report to the FDA under MoCRA), or a routine inspection. Any of those can lead to an inspection of the facility. These days, inspections are most often “virtual” with requests for and review of documents rather than an on-site visit.
When the FDA is weighing whether a recall is warranted, the guidance says it will look at things like:
- What inspectors observed during an inspection
- Lab testing of the product, its raw materials, or swabs from the manufacturing area
- Evidence that people have actually been harmed
- Serious adverse event reports
- Consumer and trade complaints
- Who uses the product (infants, toddlers, the elderly, pregnant women and people with compromised health get extra consideration)
- Whether the company has already refused to recall voluntarily
The Two-Part Test
Even with all that in hand, the FDA can only move toward a mandatory recall if both of these are true:
- There’s a reasonable probability the product is adulterated or misbranded, and
- There’s a reasonable probability that using it will cause serious adverse health consequences or death.
Adulterated covers things like contamination, insanitary manufacturing conditions, unapproved color additives, or a lack of safety substantiation. Misbranded covers labeling problems. But a labeling problem alone doesn’t meet the bar. A missing net contents statement isn’t going to put anyone in the hospital.
“Serious” means things like hospitalization, an infection, second- or third-degree burns, significant hair loss, or serious and persistent rashes. Bottom line? It’s a high bar, and correctly so.
How the Process Works
The procedure is simple, and it starts with a chance for the company to do the right thing on its own.
- The FDA contacts the company in writing and offers it the opportunity to stop distribution and recall the product voluntarily.
- If the company refuses (or doesn’t act within the time the FDA sets), the FDA can order it to immediately stop distributing the product. The order may also require the company to notify its retailers, distributors and the public.
- The company can request and get an informal hearing, held within 10 days of the order, where it can argue that the evidence doesn’t justify the order.
- The FDA then decides whether to lift the order, keep it in place until a set date, or change it into a mandatory recall with a timetable and progress updates.
Any recall is in the name of the FDA Commissioner, and has to be approved by him. Once approved and ordered, the FDA publishes a press release naming the product and describing the risk.
Once a mandatory order is in place, ignoring it can lead to an injunction or even criminal prosecution.
Final Thoughts
For most small makers, this guidance won’t change anything day to day. A mandatory recall requires a product that’s actually likely to hurt someone and a company that won’t fix the problem voluntarily.
The things that keep you far away from that scenario are things you’re probably already doing: clean manufacturing practices, safety substantiation for your products and ingredients, paying attention to customer complaints, and keeping batch records so you know what was in each batch and where it went. (If you ever do need to pull a product, that last one makes it much easier.)
Keep making good products. That’s really all it takes to avoid problems like mandatory recalls.
Leave a Reply