Recall Alert: Certain Tattoo Inks Contaminated With Bacteria

FDA alerting consumers, tattoo artists, and retailers of the potential for serious injury

In a recall notice on May 15, the U.S. Food and Drug Administration (FDA) said there are six tattoo ink products that are contaminated with bacteria and can cause serious infection and injury.

The FDA says people who plan to get a tattoo should ask their artists what inks they use. Tattoo studios and retailers are being told to no longer use or sell the six products under the recall.

“Tattoo inks contaminated with microorganisms can cause infections and lead to serious health injuries when injected into the skin during a tattooing procedure since there is an increased risk of infection any time the skin barrier is broken,” the FDA said in the recall.

For those who suspect they may have an infection, check for any rashes or lesions with red papules around where the possibly contaminated ink was applied.

The FDA noted that tattoo ink infection can result in permanent scarring. They also said that it may be hard for a person to tell whether they were infected by bacteria from tattoo ink because the initial signs and symptoms can be difficult to tell apart from other conditions, such as allergic reactions.

However, those who think they may have been infected by contaminated tattoo ink should contact their doctor and let their tattoo artists know, the FDA stated. They should also consider reporting their case to MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program.

The six products below have been recalled:

• Scalpaink SC basic black tattoo ink, manufactured by Scalp Aesthetics, all lots
• Scalpaink PA basic black tattoo ink, manufactured by Scalp Aesthetics, all lots
• Scalpaink AL basic black tattoo ink, manufactured by Scalp Aesthetics, all lots

Scalpaink SC, Scalpaink PA, and Scalpaink AL Basic Black Tattoo Inks manufactured by Scalp Aesthetics. U.S. FDA

• Dynamic Color, black tattoo ink, manufactured by Dynamic Color Inc., lots 12024090
• Dynamic Color, black tattoo ink, manufactured by Dynamic Color Inc., lots 12026090

Dynamic Color–Black Tattoo Ink manufactured by Dynamic Color Inc. U.S. FDA

• Solid Ink, Diablo (red) tattoo ink, manufactured by Color Art Inc. lot 10.19.18

Solid Ink-Diablo (red) Tattoo Ink, manufactured by Color Art Inc. U.S. FDA

“The tattoo inks were manufactured or distributed by four firms inspected under an ongoing assignment,” the agency said in the recall.

“Tattoo inks were analyzed using methods described in the Bacteriological Analytical Manual Chapter 23: Microbiological Methods for Cosmetics, which is the general method used to determine bacterial contamination of cosmetics,” the FDA said.

How to Make Sure Your Tattoo Ink is Safe

The FDA does not regulate inks that are placed under the skin, and does not require tattoo ink manufacturers to reveal the ingredients in their products. The FDA states the following in a small brochure (pdf) about its role with regard to tattoo ink:

FDA does take the following actions to promote consumer safety:

• FDA monitors problems from tattoos and permanent make-up.
• FDA alerts the public (link) when we become aware of a problem.

FDA has not/does not do the following:

• FDA has not approved any inks for injection into your skin.
• FDA has not approved henna or hair dye for use on your skin. Some people have reported serious problems after using temporary tattoos marketed as henna or black henna.
• FDA does not regulate practices in tattoo parlors. Usually, this is the job of state or local health departments.

“The bottom line is that every brand and color of tattoo ink has different ingredients, and since the makers don’t have to tell you what’s in their products, it is clearly a case of buyer beware,” writer Deborah Mitchell from Naturally Savvy, a popular healthy living website, noted.

Mitchell listed several suggestions on measure to take to improve safety before getting a tattoo:

• Ask to see the Material Safety Data Sheets (MSDS) for each of the pigments or carriers to be used in your tattoo. These information sheets will tell you about the safety and basic health information on each substance.
• Have skin tests performed on each of the inks to be used in your tattoo, even if the professional insists the inks are safe.
• Insist on inks that generally have been shown to be safe. Therefore, look for carriers that include glycerine, ethanol, and purified water rather than toxic chemicals.
• Nontoxic choices for various different colors of pigments include the following: logwood and carbon for black; titanium dioxide for white; turmeric for yellow; monoazo (carbon-based) for green; sodium, or copper for blue; dioxazine and carbazole for purple. Avoid red pigments made from cadmium red, iron oxide, or cinnabar and ask for naphthol.
• Avoid neon or vividly colored pigments, which are more likely to be toxic than other pigments.
• Consider vegan tattoo inks. Numerous companies make pigments that are animal cruelty free. You can check this list of vegan tattoo inks and ask for them by name.