Contaminated Tattoo Inks: FDA Recalls and Adverse Event Reports, 2003 to 2026

What the recall record shows

We screened every FDA Enforcement Report record that mentions tattoos, permanent makeup or microblading and kept the 23 recall events for inks that go into the skin. The first was started in July 2003, for Premier True Color Pigments (permanent makeup inks); the most recent in July 2026, for Xtreme Inks EXO Black tattoo ink.

22 of the 23 recalls were for contamination with bacteria or mold that FDA or the firm found or suspected in the ink. The one exception, in July 2003, was Premier True Color Pigments (permanent makeup inks): FDA's record says the pigments were not approved for tattooing and were linked to reactions. It is the only Class I recall in the list; the other 22 are Class II.

Recalls come in clusters. There were 8 from 2017 to 2019, none from 2020 to 2022, and 8 from January 2023 to July 2026.

Where FDA's reason names the organism, Bacillus species appear in 8 recalls and Pseudomonas species in 6. Others name Mycobacterium, Nocardia, Clostridium, Streptococcus or molds; several say only "bacteria" or "microbial contamination".

How this compares with FDA's own count

In its October 2024 notice on the final tattoo ink guidance, FDA said firms ran 18 voluntary recalls of contaminated tattoo inks between 2003 and 2024, the most recent on August 23, 2024. For the same window (July 2003 to August 23, 2024) our screen of the Enforcement Report finds 19 recall events, 18 of them for contamination, the same as FDA's count. The other one is the 2003 permanent makeup recall, which was not about contamination. FDA did not publish its own list.

FDA has also issued safety alerts naming specific inks: in May 2019 (6 contaminated inks from 4 firms) and on May 7, 2025 (2 Sacred Tattoo Ink colors).

Adverse event reports

openFDA publishes the cosmetic adverse event reports FDA receives. 495 reports received from November 2003 to August 2025 name at least one product that is a permanent tattoo or permanent makeup ink. We counted permanent tattoo and permanent makeup inks only. Numbing products, tattoo removal products, aftercare products and temporary tattoos (including henna and "black henna") are excluded, even when "tattoo" is in the name.

203 of the reports arrived in 2004. FDA's tattoo page says that in 2003 and 2004 it learned of more than 150 reactions to certain permanent makeup ink shades, which the company then recalled. 196 reports were received from 2015 onward.

A report is what a consumer, doctor or company told FDA. FDA does not confirm that the product caused the problem, and most reactions are never reported, so these counts can't show how often inks cause harm.

Method

Recalls: we exported FDA Enforcement Report Quick Search results (product level) for the terms tattoo, ink, pigment, microblading, micropigmentation, permanent makeup, henna and cosmetics on November 2026. Every recall record that mentions a tattoo-type word was reviewed; 23 recall events for tattoo or permanent makeup inks were kept and 10 were set aside (temporary tattoos, numbing sprays, laser devices, a food and loose eye pigments). One recall event can cover several products or colors; we count events. Dates are the date the firm started the recall.

Adverse events: we downloaded the full openFDA cosmetic adverse event file (updated 2026-11-09, 85,511 reports) and classified every product name that could be a tattoo, ink or henna product with written rules. A report counts if it names at least one permanent tattoo or permanent makeup ink. Numbing, tattoo removal, aftercare and temporary tattoo products (henna, waterless, logo and party tattoos) do not count. Reports that name a product only as "tattoo" count as permanent. Years are the year FDA first received the report.

The rules, the list of reviewed records and the scripts are in the site's source repository; the CSV files below hold the results.

Limits

• The Enforcement Report is FDA's record of recalls it classified, and some older recalls may be missing from its search. One recall (Solid Ink Diablo, 2019) is in our list because FDA's May 2019 safety alert names it as a tattoo ink; its Enforcement Report record does not use the word tattoo.
• We use the Enforcement Report's start date for each recall. For the permanent makeup ink recall that record gives July 7, 2003, while FDA's tattoo page says the inks were recalled in 2004.
• Recalls depend on FDA sampling and firm testing, so the yearly counts reflect enforcement activity as well as ink quality.
• Adverse event reports are unverified and incomplete. Changes in who must report (the Modernization of Cosmetics Regulation Act of 2022 added mandatory reporting of serious events for companies) and in public attention affect the counts.
• openFDA's file covers reports received through August 2025; the latest report naming a permanent tattoo or permanent makeup ink was received in February 2025.