buprenorphine / naloxone · Indivior · updated June 2026
Suboxone sublingual film faces a mass tort alleging that its acidic formulation causes severe tooth decay, erosion, and tooth loss. The FDA added a dental-problems warning to mouth-dissolved buprenorphine medicines in 2022.
This page is general information about ongoing litigation and FDA safety actions — not medical or legal advice, and not a statement that Suboxone caused any injury. Allegations described here are claims that have not been proven in court. Always consult a licensed professional.
Plaintiffs allege Indivior failed to warn that the acidic buprenorphine/naloxone film can cause severe dental erosion, decay, and tooth loss.
In January 2022 the FDA required a warning about dental problems be added to buprenorphine medicines that dissolve in the mouth.
As of mid-2026, about 1,800 cases — representing an estimated 20,000+ individual claims — are consolidated in MDL 3092 in the Northern District of Ohio. No settlement has been reached; bellwether trials are expected around 2028.