FDA Warning Issued 2022 · Thousands Filing Claims · Free Case Review

Suboxone Destroyed Your Teeth. It Wasn't Your Fault. You Have Legal Rights.

Suboxone sublingual film's acidic formula is eroding tooth enamel — causing decay, fractures, and tooth loss in patients who had healthy teeth before treatment. The manufacturer knew. The FDA warned in 2022. Now patients are fighting back.

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16M+ Americans Prescribed · FDA Warning Issued 2022 · No Fee Unless You Win · Attorneys in All 50 States
16M+
Americans Prescribed
Buprenorphine Products
2022
FDA Issued Class-Wide
Dental Warning
pH 3.4
Suboxone Film's Acidic
pH Erodes Enamel
$0
Upfront Cost to
File a Claim

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What Is the Suboxone Dental Lawsuit?

Thousands of people who used Suboxone sublingual film (buprenorphine/naloxone) to treat opioid use disorder are now filing lawsuits against the drug's manufacturer, Indivior PLC, after suffering severe dental damage — including tooth decay, fractures, and complete tooth loss.

Suboxone film is prescribed to dissolve under the tongue, where it's absorbed into the bloodstream. But the film's highly acidic formulation — with a pH of approximately 3.4 (similar to orange juice) — also bathes the teeth in acid repeatedly, day after day, for months or years. Over time, this acid erodes tooth enamel, causing serious and often irreversible dental damage.

Many patients who used Suboxone as directed had no dental problems before starting treatment. After months or years of use, they found themselves with rotting teeth, broken teeth, and extractions — expenses not covered by insurance that often run into tens of thousands of dollars.

Key Facts at a Glance

  • Drug: Suboxone sublingual film (buprenorphine/naloxone) — made by Indivior PLC
  • Problem: Film's acidic pH (~3.4) erodes tooth enamel with daily sublingual use
  • FDA Action: June 2022 — class-wide dental warning required for all buprenorphine oral dissolution medicines
  • Litigation: Cases being filed and consolidated — Northern District of Ohio
  • Defendants: Indivior PLC, Indivior Inc., Aquestive Therapeutics (film manufacturer)
  • Key allegation: Manufacturers knew about dental risk from clinical trials and failed to warn
  • ~16 million Americans have been prescribed buprenorphine products

Why Didn't Anyone Warn You?

This is one of the most important parts of this litigation: patients weren't warned for years — even though the manufacturers had information about dental risks from clinical development.

The FDA's June 2022 warning states that the agency received reports of "severe dental problems," including "tooth decay, cavities, oral infections, and loss of teeth" in patients using buprenorphine sublingual medicines. These problems were reported even in patients who had never had dental problems before.

There are several reasons patients often didn't connect their dental problems to Suboxone:

  • Many patients assumed their dental problems were from past substance use — and felt too embarrassed or ashamed to discuss it with their doctors
  • Dentists weren't warned — so they also didn't connect the dots
  • The FDA warning came years after the drug became widely prescribed
  • Suboxone helped people recover — patients focused on staying well, not watching their teeth

This was not your fault. You were prescribed a medication by your doctor. You followed the instructions. The manufacturer had an obligation to warn you — and they didn't.

Did Suboxone Film Damage Your Teeth?

If you used Suboxone sublingual film and experienced tooth decay, fractures, or tooth loss, you may qualify for compensation. Find out in 2 minutes — free and confidential.

Check My Eligibility →

Do You Qualify for a Suboxone Dental Injury Lawsuit?

You may be eligible to file a claim if the following apply:

Basic Eligibility Criteria

  • You used Suboxone sublingual film (the dissolving strips, not the tablet form)
  • You used it for at least 6 months (longer use = stronger connection)
  • You experienced dental problems — decay, fractures, tooth loss, extractions, or significant dental procedures — after starting Suboxone
  • Your dental problems were not present before you started Suboxone, or worsened significantly after starting
  • You are within your state's statute of limitations (the discovery rule may extend your deadline)

Important note on the discovery rule: Many states allow the statute of limitations clock to start when you discovered (or reasonably should have discovered) that Suboxone caused your dental damage — not when the damage first appeared. This is especially relevant for patients who attributed their dental problems to prior substance use. You may have more time than you think.

How Does Suboxone Damage Teeth?

The mechanism is straightforward: Suboxone sublingual film has a highly acidic pH of approximately 3.4. For comparison, battery acid has a pH of about 1, and tooth enamel begins to dissolve at pH 5.5. Orange juice has a pH of around 3.5.

When you place Suboxone film under your tongue, the dissolving film creates an acidic environment in your mouth that lasts for 5-10 minutes. Used as directed — once or twice daily, every day, for months or years — this repeated acid exposure causes:

  • Demineralization of tooth enamel (the protective outer layer)
  • Dental erosion — enamel wears away permanently
  • Tooth decay and cavities — bacteria thrive in damaged enamel
  • Tooth sensitivity, followed by pain, cracking, and fractures
  • Root exposure, oral infections, and abscess formation
  • Tooth loss requiring extraction, dentures, or expensive implants
See Full List of Dental Injuries →

The 2022 FDA Warning — What You Need to Know

In June 2022, the FDA took action that Indivior and Aquestive Therapeutics should have taken years earlier. The FDA:

  • Required a class-wide warning about dental problems for all buprenorphine medicines that dissolve in the mouth
  • Stated that "cases of severe dental problems have been reported" — including decay, cavities, fractures, infections, and tooth loss
  • Confirmed that dental problems occurred even in patients who had no prior dental issues
  • Required prescribers to counsel patients about dental risks
  • Recommended patients rinse their mouth with water after each dose and schedule regular dental visits

Plaintiffs argue that this warning came years too late — and that Indivior had access to dental adverse event data from clinical trials long before the 2022 FDA action.

Read the Full FDA Warning →

Who Is Being Sued?

The Suboxone dental injury litigation names multiple defendants:

  • Indivior PLC and Indivior Inc. — the current manufacturer and marketer of Suboxone film, formerly part of Reckitt Benckiser
  • Aquestive Therapeutics — the contract manufacturer that developed the sublingual film technology and manufactured Suboxone film

The core allegation is that these companies knew about the dental risks from pre-approval clinical trials and post-market adverse event reports, but chose not to adequately warn patients, dentists, or prescribers.

Frequently Asked Questions

Does it matter if I took generic buprenorphine film, not brand-name Suboxone?
If you used generic buprenorphine/naloxone sublingual film (not tablets), you may still qualify. The acidic pH problem relates to the sublingual film delivery mechanism. Consult with an attorney about your specific formulation and history.
I thought my dental problems were from my history of substance use. Can I still file?
Yes, and this is actually one of the most important aspects of this litigation. Many patients — and their dentists — assumed dental problems were from prior substance use, not Suboxone. The discovery rule in most states starts your deadline from when you discovered (or should have discovered) the connection to Suboxone. You may have more time than you think.
What kind of dental damage qualifies?
Qualifying injuries include significant tooth decay (especially if you had healthy teeth before Suboxone), tooth fractures or cracking, tooth loss or extractions, oral infections or abscesses, need for root canals, crowns, dentures, bridges, or dental implants. Minor cavities may not qualify — the focus is on serious dental damage.
How long do I have to file?
It depends on your state. Most states allow 2-3 years from when you discovered the connection between Suboxone and your dental injuries. Some states have shorter deadlines (Louisiana and Kentucky: 1 year). Don't wait — check your state's specific deadline and consult an attorney promptly.
What compensation could I receive?
Potential compensation may include reimbursement for dental treatment costs (past and future), pain and suffering, lost wages, and other damages. No settlements have been finalized yet in this litigation, and no attorney can guarantee a specific outcome. Cases are evaluated on individual merits.
Is this litigation real? I haven't heard about it.
Yes. The FDA dental warning is real and publicly documented (June 2022). Cases are being filed against Indivior and are being consolidated in federal court. The litigation is in earlier stages than some mass torts, which is actually beneficial for filing — earlier cases often receive more favorable treatment in any eventual settlement structure.

Suboxone Dental Lawsuit Information by State

Filing deadlines vary by state. Find information specific to your state, including statute of limitations and local resources.

Texas Florida California New York Ohio (MDL) Pennsylvania Illinois Georgia North Carolina Michigan Kentucky West Virginia

View All 50 States →

You Deserve to Know If You Have a Claim

Tens of thousands of people prescribed Suboxone suffered dental damage they were never warned about. A free case evaluation takes 2 minutes and costs you nothing.

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Disclaimer: Ruja Media LLC is not a law firm and does not provide legal advice. This website is an educational and referral resource only. Submitting a form does not create an attorney-client relationship. No attorney can guarantee a specific outcome. Individual results vary based on facts and circumstances.
Did Suboxone destroy your teeth? You may qualify for compensation. Check Eligibility →