Sealed isn't sterile.
What FDA found inside tattoo and PMU ink.

Short answer: tattoo and permanent makeup (PMU) inks can carry bacteria even when the bottle is new and sealed. FDA scientists found contamination in about 35% of 75 sealed inks they tested, and FDA has warned the public about specific contaminated inks several times, most recently in May 2025. On October 22, 2026, FDA finalized guidance on its power to order cosmetic recalls, a category that includes these inks. You cannot see contamination, so your protection is a registered artist in a permitted facility, a traceable ink with a lot number, single-use dispensing, no tap-water dilution, and knowing which healing signs are not normal.

The moment nobody thinks about

You have spent weeks on the brow shape. You have saved photos, compared healed results and picked a shade that suits your undertone. You lie back, the artist opens a small bottle, pours a drop into a cup and starts. Almost nobody asks about the bottle itself: who made it, which batch it came from, whether anything was added to thin it.

That is understandable. Ink feels like the least interesting part of the appointment. But every PMU technique, from powder brows to lash-line eyeliner, places pigment into the skin with a needle. Whatever is in that drop, including microbes, goes with it. The American system also leans heavily on the honesty and housekeeping of manufacturers and artists, because there is no premarket approval of these inks the way there is for an injectable drug.

What happened: recalls, an outbreak and a study, in order

This is not a single scary headline. It is a pattern that public health agencies have documented for more than a decade. Here are the verified milestones, with their real dates.

Inside the FDA study: what “35%” really means

The 2024 study came from microbiologists at FDA's National Center for Toxicological Research in Jefferson, Arkansas. They bought 75 unopened tattoo and permanent makeup inks from 14 manufacturers and cultured them, including in an oxygen-free chamber to catch anaerobic bacteria that ordinary tests can miss. The manufacturers were not named publicly.

• 26 of 75 samples (about 35%), from 10 of the 14 manufacturers, contained bacteria.
• The team identified 34 bacterial isolates from 22 species; 19 were considered possibly pathogenic.
• Anaerobes found in sealed bottles included Cutibacterium acnes and Staphylococcus epidermidis, both common skin bacteria that can still cause trouble when pushed into the dermis.
• Most contaminated samples had low counts, under 250 colony-forming units per gram, but a few reached about 100,000 per gram, according to CNN's report on the study.
• There was no significant link between a “sterile” label and the absence of bacteria.

Two honest caveats. First, finding bacteria in a bottle is not the same as proving that clients got sick from it; the study measured contamination, not infections. Second, 75 inks is a snapshot, not a census of every brand on the market. Still, when an agency's own scientists find bacteria in roughly one in three sealed bottles, the takeaway is clear: sealed is not the same as sterile, and safety has to be built in at every step, from factory to cup.

In CNN's coverage, an FDA cosmetics official noted that permanent makeup around the eyes may carry higher risk, because microbes there could reach the eye. That is worth remembering if you are considering permanent eyeliner.

The new part: FDA's recall rulebook, finalized October 2026

For most of the history above, recalls of tattoo ink depended on companies acting voluntarily, with FDA issuing public advisories when they did not. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) changed that for cosmetics. According to FDA, the agency can now order a recall if the responsible company declines to recall voluntarily and FDA finds a reasonable probability that a cosmetic is adulterated or misbranded and that its use will cause serious adverse health consequences or death.

FDA's fact sheet on tattoos and permanent makeup states that it regulates intradermal tattoo and PMU inks as cosmetics. So the October 22, 2026 guidance, which explains when FDA may order a recall, how the process works and what companies must do to comply, is part of the rulebook that covers the pigments used for brows, lips and eyeliner. MoCRA also requires companies responsible for cosmetics to report serious adverse events to FDA within 15 business days.

What it does not do: it does not test the bottle on your artist's cart. A recall works after a problem is found. FDA's manufacturing guidance for ink makers remains non-binding, and FDA's fact sheet notes that no color additive has been approved for injection into the skin. Day to day, your safety still depends on the people and the room.

Why contamination happens (and the mistake behind most of it)

FDA and CDC point to a few recurring causes:

• Contaminated product from the factory. The 2012 New York cluster traced back to a prediluted ink, and the artist said he had not diluted it.
• Thinning ink with nonsterile water. FDA calls nonsterile water a common cause. CDC adds a detail most people do not know: distilled and reverse-osmosis water are not necessarily sterile.
• Double-dipping and open bottles. California's Safe Body Art Act requires inks to be dispensed in a way that prevents contamination of the container and what is left inside, which is why single-use cups exist.
• Homemade inks and do-it-yourself kits. FDA links DIY inks and kits to infections and allergic reactions.

The common mistake on the client side is assuming that a clean-looking studio and a new bottle mean the ink is fine. On the industry side, it is treating ink as a commodity: buying on price, not tracking lot numbers, and topping up with water. The fix is traceability and single-use habits, and you are allowed to ask about both.

What California and Orange County already require

Tattooing practice, including permanent cosmetics, is regulated locally in California under the Safe Body Art Act. Los Angeles County's summary of the state law lists rules that matter to you as a client:

• Only commercially manufactured inks, dyes and pigments may be used.
• Inks must be dispensed so the container and remaining contents are not contaminated.
• You must read and sign a consent form that includes a health questionnaire and states that tattoo inks, dyes and pigments have not been approved by FDA.
• Your practitioner must give you aftercare instructions, and clients must be 18 or older for tattoos and permanent cosmetics.

In Orange County, the Health Care Agency's Body Art Program says permanent cosmetics count as body art. Every practitioner must be registered, which requires a bloodborne pathogen training certificate, and body art may only be done in a facility with a valid permit that passes an inspection and is renewed every year. If you live in Santa Ana, the program's office is close to home, on East Dyer Road, and it takes questions at ocbodyart@ochca.com or its Body Art Hotline at (714) 433-6040. Our guide to choosing a permanent makeup artist covers registration and permits in more depth.

Do / Don't before permanent makeup

Do:

• Ask for the ink brand, color and lot number, and keep a photo of the label with your aftercare sheet.
• Read the consent form and health questionnaire properly and answer honestly about your health history.
• Watch for single-use needles and cartridges opened in front of you, fresh gloves and a single-use pigment cup.
• Check FDA's cosmetics recalls and alerts page if you are curious about a brand.

Don't:

• Book permanent makeup at a house party, in a home without a permit, or with a DIY kit.
• Assume “sterile,” “vegan,” “organic” or “medical grade” on a label means contamination-free.
• Let price be the deciding factor on a procedure that puts pigment under your skin.
• Stay quiet if you see an artist top up a pigment cup with water from a sink or a drinking bottle.

Normal healing vs. signs to call a clinician

Some reaction is expected. FDA lists redness, swelling and warmth as normal early effects. Our week-by-week PMU healing guide shows what a typical recovery looks like. What is not typical:

• A rash of red bumps or lesions confined to the pigmented area. FDA describes this as a common sign of infection from contaminated ink.
• An area that is not healing, or redness and swelling that build instead of settling.
• Fever. High fever, shaking, chills or sweats can signal a serious infection; seek urgent care.
• A reaction that starts a week or more later. In CDC's New York cluster, symptoms began about a week after tattooing.
• Any eye pain, discharge or vision change after eyeliner. See an eye doctor promptly.

There is a reason not to self-diagnose: FDA notes that early infections can look like an allergic reaction, which can lead to the wrong treatment. Mycobacterial infections in the 2012 outbreak needed at least four months of two or more antibiotics, and some cases needed surgery. Tell the clinician you recently had permanent makeup, share the ink details, let the artist know so they can pull that ink, and report the problem to FDA.

One more practical point: laser tattoo removal is not a treatment for an infection. If you have a healed result you dislike, that is a different conversation, covered in our guide to PMU correction vs. removal.

When to postpone your appointment

Permanent makeup asks your skin to heal a lot of tiny wounds. The Safe Body Art Act health questionnaire asks about pregnancy, herpes at the procedure site, diabetes, bleeding disorders, latex or antibiotic allergies, heart valve disease and medications for a reason. If any of these apply, or you have an active breakout, cold sore or skin infection in the area, talk to your clinician and your artist before booking. Our guide to who should avoid permanent makeup goes through each.

What the good version looks like

Picture the calmer version of that first scene. Your artist shows you the bottle, reads out the lot number and notes it on your consent form. The pigment goes into a fresh cup that will be thrown away when you leave. Nothing is thinned with water from the sink. You leave with written aftercare, the ink details in your phone and a clear idea of what normal healing looks like. Two weeks later, the soft, slightly patchy healing phase you were warned about has settled, and the only thing you think about when you look in the mirror is the shape.

That is what good practice feels like: unremarkable, transparent and boring in the best way.

How this works at Enclave

Enclave's permanent makeup menu includes Upper or Lower Eyeliner from $385, Ombré Powder Brows from $495 and Lip Blush from $550. You can start with a free consultation about your skin, health history and goals, and you are welcome to ask us every question on the list above. If you are carrying older pigment you want lightened before new work, Eyebrow Tattoo Removal starts from $250 per session. Prices are starting points and can change, so check the services page for current pricing.

Our studio is on West 5th Street in Santa Ana, a few minutes from the Little Saigon corridor in Westminster and Garden Grove. If you are coming from Irvine, Tustin or Costa Mesa, give yourself unhurried time: a good PMU consultation includes reading the consent form, not signing it in the parking lot.