Buprenorphine (Suboxone): the legal and safety record

The criminal record: one felony plea, two misdemeanors, stated exactly

On July 24, 2020, Indivior Solutions — the sales-and-marketing subsidiary, not the parent — pleaded guilty to a one-count felony information charging false statements relating to health care matters. What it admitted is specific: in October 2012, seeking expanded Medicaid coverage, it sent the Massachusetts Medicaid program (MassHealth) false data claiming Suboxone Film had the lowest rate of accidental pediatric exposure of all buprenorphine drugs in Massachusetts, when in fact it did not. The Indivior entities paid $600 million: $289 million in criminal fine, forfeiture and restitution, plus a $300 million civil settlement — and DOJ’s own release marks the civil claims as allegations only, with no determination of liability [1]. The felony charges a grand jury had filed against the parents, Indivior Inc. and Indivior plc, in April 2019 were dismissed as part of the resolution, subject to reinstatement if the agreement is violated [1].

Two executives were convicted, and both convictions are misdemeanors — a word this page will not round up. Former CEO Shaun Thaxter pleaded guilty on June 30, 2020 to one misdemeanor count of causing misbranded Suboxone Film to enter interstate commerce, and was sentenced to six months of incarceration and $600,000 in fines and forfeiture [2][3]. Former medical director Tim Baxter pleaded guilty to a one-count misdemeanor as well [3]. Six months in federal custody is a real sentence; it is still not a felony, and secondary sources that write otherwise are wrong.

The year before, Indivior’s former parent Reckitt Benckiser Group resolved its exposure for $1.4 billion — and the form matters as much as the figure. Reckitt signed a non-prosecution agreement: a $647 million forfeiture and a three-year bar on US controlled-substance business, but no charge, no plea, no conviction. The $700 million civil component is, again in DOJ’s own words, allegations only with no determination of liability; $50 million more went to an FTC administrative resolution [4]. Together with the Thaxter plea, DOJ called the more than $2 billion total the largest resolution it had ever obtained in a case involving an opioid drug [1].

The scheme was a safety claim: the film, the tablets, and the generics

The conduct running through all of these cases has a shape worth understanding, because it is the same shape the FTC alleged in its antitrust cases: as Suboxone tablets neared generic competition, the companies moved the market to the patent-protected film — and the FTC alleged the lever was a safety claim, telling doctors the film was safer around children, plus a citizen petition to FDA reciting what the FTC called unsupported safety claims to slow generic tablets down [5]. Reckitt settled those charges for $50 million and Indivior for $10 million — settlements of allegations, not adjudications, with no admission of wrongdoing [5][6]. In May 2021 the FTC sent 51,875 payments totaling more than $59 million, averaging $1,139, to people who were allegedly overcharged for their own addiction treatment [6].

The private antitrust track ended the same way: settled, not adjudicated. In the multidistrict litigation in Philadelphia (MDL 2445), Indivior signed a $385 million settlement with the class of direct purchasers on October 22, 2023 — shortly before trial — and the court granted final approval on February 27, 2024 [7][8]. The agreement itself, filed with the SEC, says it “shall not be deemed or construed to be an admission or evidence of any violation of any statute or law or of any liability or wrongdoing” [7]. No jury ever decided the antitrust claims, and this page will not write as though one did.

The safety record, kept separate from the legal one

• Boxed warnings are a per-product fact. Suboxone film — the product at the center of everything above — carries no boxed warning on its current label. The buprenorphine products approved for pain (Butrans, Belbuca) do, for addiction, abuse, misuse and life-threatening respiratory depression; Sublocade, the monthly injection for opioid use disorder, carries one about serious harm or death if injected intravenously [10]. “Buprenorphine has a black box warning” is true of some products and false of the one most readers mean, and pages that blur them are rounding.
• The 2022 dental warning is real and bounded. FDA identified 305 cases of dental problems — decay, cavities, infections, tooth loss — with buprenorphine dissolved in the mouth, 131 of them serious, and required new label warnings. The same communication recommends oral care and check-ups, not stopping, and states that the benefits clearly outweigh the risks [9].
• No Class I recall (within openFDA’s ~2012-onward coverage window). Thirty recall records, 26 Class II and four Class III, for manufacturing and quality problems rather than anything about the molecule [11].
• No adjudicated injury verdicts in any of this. The felony was a false statement to a Medicaid program about comparative pediatric-exposure data; the antitrust cases were about prices. Nothing in the record is a court finding that buprenorphine harmed a patient or fails to work — a page that lets you infer otherwise is overreaching, in either direction.

The label, the reporting data, and the approval history are on our buprenorphine page, caveats first.

Common questions

Did Suboxone’s manufacturer plead guilty to a crime?

Yes — and the precision matters. On July 24, 2020, Indivior Solutions, the sales-and-marketing subsidiary, pleaded guilty to a one-count felony information charging false statements relating to health care matters: in October 2012 it sent the Massachusetts Medicaid program false data claiming Suboxone Film had the lowest rate of accidental pediatric exposure of all buprenorphine drugs in Massachusetts, when it did not. The parent companies, Indivior Inc. and Indivior plc, did not plead guilty; the felony charges from their 2019 indictment were dismissed as part of the resolution, subject to reinstatement if the agreement is violated. The Indivior entities together paid $600 million — $289 million criminal, $300 million civil.

Was Indivior’s CEO convicted of a felony?

No. Former CEO Shaun Thaxter pleaded guilty on June 30, 2020 to a one-count misdemeanor — causing the introduction of misbranded Suboxone Film into interstate commerce under the Food, Drug, and Cosmetic Act — and was sentenced on October 22, 2020 to six months of incarceration and $600,000 in fines and forfeiture. A misdemeanor with real jail time is still a misdemeanor, and pages that write “felony” are rounding up. Former medical director Tim Baxter also pleaded guilty to a one-count misdemeanor.

What was the $1.4 billion Reckitt Benckiser payment?

Not a conviction. In July 2019, Reckitt Benckiser Group — Indivior’s former parent — resolved its potential liability through a non-prosecution agreement with a $647 million forfeiture, civil settlements of $700 million with the federal government and states, and a $50 million FTC administrative resolution. DOJ’s release states the civil claims are allegations only with no determination of liability, and a non-prosecution agreement means exactly what it says: Reckitt was not prosecuted and admitted no crime.

Should this record make me avoid Suboxone or stop taking it?

No, and this is the one answer on this page we will state as advice-adjacent fact rather than neutral record. Every criminal and civil matter above is about marketing conduct and pricing — none is a finding that buprenorphine does not work or harmed a patient as designed. The treatment evidence runs the other way: a BMJ systematic review found all-cause mortality of 4.3 per 1,000 person-years in buprenorphine treatment versus 9.5 out of it, and FDA’s 2022 safety communication states that the benefits of these medicines clearly outweigh the risks. If anything on this page bothers you, bring it to your prescriber — do not act on it alone.

Does buprenorphine have a boxed warning?

It depends on the product, and blurring them is how pages get this wrong. Suboxone film — the opioid-use-disorder product at the center of the legal record — carries no boxed warning on its current FDA label. Buprenorphine products approved for pain do: Butrans (transdermal) and Belbuca (buccal film) carry boxed warnings covering addiction, abuse, misuse and life-threatening respiratory depression. Sublocade, the monthly injection for opioid use disorder, carries a boxed warning about serious harm or death if self-injected intravenously, with a restricted distribution program. “Buprenorphine has a black box warning” is true for some products and false for the one most readers mean.

What is the FDA dental warning about?

On January 12, 2022, FDA warned that buprenorphine medicines dissolved in the mouth — films and tablets, including Suboxone — have been associated with dental problems: tooth decay, cavities, oral infections and tooth loss, including in people with no prior dental history. FDA identified 305 cases, 131 of them serious, and required new warnings in the prescribing information and Medication Guide. The same communication says the benefits of these medicines clearly outweigh the risks, and recommends oral-care steps rather than stopping treatment.

Have there been serious buprenorphine recalls?

No Class I recall — FDA’s most serious category — appears in the openFDA enforcement database (that dataset is reliable only from roughly 2012 onward, so this is a statement about the covered window, not the drug’s whole history). Thirty records exist: 26 Class II and four Class III, for manufacturing, packaging and quality issues rather than anything about the molecule.

Sources

Last verified 2026-09-08. Corrections change this date.