The following tattoo inks have been recalled in the USA for safety and contamination with microorganisms:
DYNAMIC COLOR – BLACK
SOLID INK – DIABLO RED, ORANGE, (dba Color Art, Inc., dba Antone’s Ink)
Voluntary Tattoo Ink Recalls From the US FDA
“Recalls, Market Withdrawals, & Safety Alerts“
Eternal Ink: True Blue, Dark Red
September 25, 2018: “Eternal Ink Inc. is voluntarily recalling Eternal Ink Tattoo Ink, True Blue Ink due to potential microbial contamination.
Codes: Eternal Ink Tattoo Ink, 2 fl. oz./60 mL, Blue Ink, Lot #352, Manufactured 12/18/2017; Exp. Date: 12/18/20
Contact: Eternal Ink Inc., 7987 Lochlin Dr., Brighton, MI 48116-8329
“…Dark Red Ink due to potential microbial contamination.
Codes: Eternal Ink Tattoo Ink, 2 fl. oz./60 mL, Red Ink, Lot #352, Manufactured 12/18/2017, Exp. Date: 12/18/20
Contact: Eternal Ink Inc., 7987 Lochlin Dr., Brighton, MI 48116-8329″
Solid Ink: Orange
May 15, 2018: Solid Ink has recalled Solid Ink Orange (tattoo ink) (Batch #8297) which resulted positive for Bacillus pumilus, Bacillus licheniformis, and Pseudomonas sp.
Codes: Solid Ink Orange (tattoo ink) (Batch #8297), EXP DATE 8/21
Contact: Solid Ink, 16600 NE 54th Ave #6, Miami Gardens, FL 33014
Intenze: Bright Red & Royal Blue
Intenze: Bright Red Recalled for Microbial Organisms Intenze: Royal Blue Recalled for Microbial Organisms
“June 26, 2018 Description: Intenze Products has initiated a recall of tattoo inks because of microbial organisms (bacillus halosaccharovorans, brachybacterium conglomeratum, and pseudomonas andersonii and pseudomonas balearica) in the inks.
Codes: Intenze Bright Red Tattoo Ink (Lot SS264), 2 OZ Class II Lot SS264 Bright Red (Lot SS264) and Royal Blue (Lot SS258)
Contact: Intenze Products, 215 Nl-17, Rochelle Park, NJ 07662″
Radiant Colors: Lining Black
December 12, 2017. Description: Radiant Colors Inc. recalled Radiant Colors Victor Portugal Lining Black since it was found to contain Bacillus altitudinis.
Codes: 1 oz. plastic bottlevLot 003, Exp. 0918
Contact: Radiant Colors, Inc., 7365 Melrose Ave., Los Angeles, CA 90046-7526
Fusion Ink: Royal Blue, Light Blue, Pretty Purple, Gamma Green, & Orange.
“November 14, 2017. Description: Fusion Ink, LLC recalled Royal Blue Glycerin Tattoo Ink packaged in 1oz, 2oz, 4oz, 8oz bottles due to Microbial contamination of tattoo ink.
Codes: Best by 04/10/2020
“Description: Fusion Ink, LLC recalled Light Blue tattoo ink packaged in 1oz, 2oz, 4oz, 8oz bottles due to Microbial contamination of tattoo ink.
Codes: Best by 07/11/2020
“Description: Fusion Ink, LLC recalled Pretty purple tattoo ink packaged in 1oz, 2oz, 4oz, 8oz bottles due to Microbial contamination of tattoo ink.
Codes: 1oz, 2oz, 4oz, 8oz bottles-Best by 07/11/2020
“Description: Fusion Ink, LLC recalled Gamma Green tattoo ink packaged in 1oz, 2oz, 4oz, 8oz bottles due to Microbial contamination of tattoo ink.
Codes: 1oz, 2oz, 4oz, 8oz bottles- Best by 07/13/2020
“Description: Fusion Ink, LLC recalled Orange color tattoo ink packaged in 1oz, 2oz, 4oz, 8oz bottles due to microbial contamination of tattoo ink.
Codes: Ink packaged in 1oz, 2oz, 4oz, 8oz bottles- Best by 04/10/2020
Contact: Fusion Ink, LLC – Texas, 1012 W Broadway St., Winnsboro, TX 75494-2004″
“Adverse reactions to tattoo inks without preservatives
• ‘Starbrite Colors‘ website bragged that no preservatives or other additives were used in their tattoo inks
• Claims included
– The inks are made with sterilized distilled water
– The ink is not an alcohol-based tattoo ink”
“Starbrite Ink microbial contamination
• 2004: Belgium withdrew “Starbrite Colors” tattoo ink from market because of microbial contamination
• FDA analyses found bacteria (Pseudomonas aeruginosa) and mold (Acremonium)
• Resulted in manufacturer recall of Starbrite ink
• Starbrite ink became contaminated because the manufacturer removed the alcohol preservative from their ink formula”
“More microbial contamination of tattoo inks
• In 2011 there were several outbreaks in the U.S. possibly linked to bottled tattoo ink
• Non-tubercular mycobacterium (NTM) was isolated from bottled ink
• Other pathogens have been isolated
• New England Journal of Medicine article
– Kennedy, BS, Bedard B, Younge M, et al. Outbreak of Mycobacteriumchelonae Infection Associated with Tattoo Ink. N ENGL J MED 2012; 367:1020-1024 September 13, 2012″
“Contamination sources
• NTM is commonly found in public water supplies
• Cannot be removed by filtration
• Spores can only be destroyed by sterilization
– Problem: sterilization may affect pigments
• NTM and other pathogens may be introduced by the user
– Diluting with water, pouring back unused ink, storing open containers”
“March 23, 2005 – Product Tattoo Ink: Starbrite brand Black Magic Color, packaged in individual 1.”
Sources: USA Food and Drug Administration
“Product
“The following tattoo inks have been voluntarily recalled because they are contaminated with microorganisms:
- Scalpaink SC, Scalpaink PA, and Scalpaink AL basic black tattoo inks manufactured by Scalp Aesthetics (all lots distributed from 8/6/2018 through 10/1/2018) – Recall Completion Date 5/17/2019
- 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)
“Content current as of: 08/24/2020”
https://www.fda.gov/cosmetics/cosmetics-recalls-alerts/fda-advises-consumers-tattoo-artists-and-retailers-avoid-using-or-selling-certain-tattoo-inks?fbclid=IwAR0-IdPhx_oHUnLA4MPs8aEybzgF8_S9hOeHu3Zevuj5Std5ZReyD1D77q8
“Recalls, Market Withdrawals, & Safety Alerts
Content current as of: 01/04/2022″
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
USA FDA “Tattoo Pigments: Regulation, Chemistry, Photostability, and Potential Complications in the Human Body” by: Kathleen Lewis, Senior Advisor, Office of Cosmetics & Colors, Center for Food Safety & Applied Nutrition, US FDA. (pp. 23-28)
https://www.afdo.org/wp-content/uploads/2020/09/Tattoo-Pigments-clean.pdf