The U.S. Food and Drug Administration published formal guidance on preventing microbial contamination in tattoo inks and has stepped up alerts and recalls following multiple contamination events. In 2024–2025 the agency issued guidance on “insanitary conditions” and flagged several ink batches linked to bacterial contaminants (e.g., Pseudomonas) — a reminder that unopened, commercially packaged inks have sometimes been contaminated during production or distribution. The practical effect: larger ink manufacturers are expanding sterility testing and batch documentation, and clinics/artists are being urged to use sterile, single-use ink aliquots and follow manufacturer lot checks.
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