FDA recalls six types of Tattoo Ink

By: David M. Higgins II

Washington, D.C.- The U. S. Food and Drug Administration has issued an advisory and recall for six different types of Tattoo Ink sold by three companies due to contamination from bacteria harmful to humans.

The recalled lots are:

  • Scalpaink SCScalpaink PA, and Scalpaink AL basic black tattoo inks manufactured by Scalp Aesthetics (all lots)
  • Dynamic Color – Black tattoo ink manufactured by Dynamic Color Inc  (lots 12024090 and 12026090)
  • Solid Ink-Diablo (red) tattoo ink manufactured by Color Art Inc. (dba Solid Ink) (dba Antone’s Ink) (lot 10.19.18)

Scalpaink SC, Scalpaink PA, and Scalpaink AL Basic Black Tattoo Inks (manufactured by Scalp Aesthetics)

The FDA is alerting consumers, tattoo artists, and retailers of the potential for serious injury from use of tattoo inks that are contaminated with bacteria. 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.

Dynamic Color – Black Tattoo Ink (manufactured by Dynamic Color Inc)

Commonly reported symptoms of tattoo-ink-associated infections include the appearance of rashes or lesions consisting of red papules in areas where the contaminated ink has been applied. Some tattoo infections can result in permanent scarring. Indications of an infection can be difficult to recognize as other conditions (e.g., allergic reactions) may initially have similar signs and symptoms, leading to misdiagnosis and ineffective treatments.

Solid Ink-Diablo (red) Tattoo Ink (manufactured by Color Art Inc.)

The FDA has become aware of contaminated tattoo inks through its FY2018-2019 inspections of distributors and manufacturers, routine surveys of marketed tattoo inks, and subsequent microbiological analysis of sampled tattoo inks. The FDA has identified 6 tattoo inks contaminated with bacteria harmful to human health. The tattoo inks were manufactured or distributed by 4 firms inspected under an ongoing assignment. 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.

Consumers who have experienced symptoms of infection or an injury after administration of a tattoo should consult their healthcare professional and inform their tattoo artist. Consumers should also consider reporting their injury to MedWatch: FDA’s Safety Information and Adverse Event Reporting Program