Nevada-based Sierra Stain is recalling several bottles of tattoo inks amid concerns of microbial contamination, according to a U.S. Food and Drug Administration notice.
The products were manufactured last year and have June-July 2026 expiry dates.
Packed in PET bottles with black dispense screw top and distributed via Amazon across all 50 U.S. states, the items contain “high concentrations of microorganisms which present a health concern to consumers,” the FDA said.
“Commonly reported symptoms of tattoo ink associated infections include the appearance of rashes or lesions consisting of red papules solely in areas where the contaminated ink has been applied. Some tattoo infections can result in permanent scarring,” the notice warned.
Certain symptoms may be difficult to recognize as they may be similar to symptoms seen in other conditions like allergic reactions. No illnesses have been reported so far from the recalled products, the FDA said.
The recall was initiated after an analysis of product samples by the FDA tested positive for multiple microbes.
The company asked tattoo artists and retailers to avoid using or selling the recalled inks. In case they already have purchased the items, the products must be disposed of in a sharps container—specially designed containers used to discard “sharp” medical waste like needles.
Tattoo Ink Risks
A U.S. study published last month found that roughly 35 percent of tattoo or permanent makeup inks it tested were contaminated with bacteria. The analysis was conducted on 75 inks from 14 manufacturers.The researchers did not find any “clear link between a product label claiming sterility and the actual absence of bacterial contamination,” said Seong-Jae Kim, an author of the study and a microbiologist with the Division of Microbiology, National Center for Toxicological Research at the FDA.
“The rising popularity of tattooing in recent years has coincided with an increase in tattoo-related complications or adverse reactions.”
In addition to microbial infections, other issues like immunologic complications, allergic hypersensitivity, toxic responses, and inflammatory reactions are also associated with tattoo inks, he stated.
The author called for continuous monitoring of tattoo ink products to ensure they are free from microbial contamination.
“More aggressive infections may cause high fever, shaking, chills, and sweats. Treating such infections might require a variety of antibiotics—possibly for months—or even hospitalization and/or surgery,” the agency stated.
