citalopram & escitalopram: the legal and safety record

The 2010 resolution, count by count

In September 2010, Forest Pharmaceuticals pleaded guilty and the Forest companies paid more than $313 million [1]. The counts, kept attached to the right drugs:

• Obstruction of justice — for conduct concerning Levothroid, a thyroid drug distributed without approval. Not the antidepressants. Most retellings get this wrong within a sentence.
• Off-label promotion of Celexa — for use in children and adolescents, an unapproved use during the conduct period. The government alleged Forest publicized a favorable pediatric study while not disclosing a contemporaneous negative European study [1].
• The civil settlement — Celexa and Lexapro — roughly $149 million resolving False Claims Act allegations, including kickbacks to prescribers: cash styled as grants or consulting fees, meals, and entertainment [1][2]. Civil settlements resolve allegations without a determination of liability, and that phrase is doing real work here.

One coexisting fact the angriest retellings omit: escitalopram later received an FDA indication for adolescent depression, in 2009. The conduct was about promotion before and without approval — not proof the drug can never be appropriate for a teenager. Both facts are the record.

What is not in the record

• No Class I recall for either molecule. Citalopram: eight records, all Class II/III, terminated. Escitalopram: two, both terminated [3]. A related non-recall safety fact: the FDA capped recommended citalopram dosing in 2011–2012 over QT-interval concerns — a label change worth asking about if you take a high dose, and a different thing from a recall.
• No adjudicated efficacy or injury finding. The 2010 case decided marketing-conduct counts; no court ruled the drugs ineffective or harmful. On adult efficacy the trial evidence is elsewhere and points the other way — escitalopram ranked among the better performers in the largest antidepressant comparison — and it lives with its funding lines on our escitalopram page and our citalopram page.

What this means if you take one of these

Escitalopram is the second-most-taken drug in our library — 9.4 million Americans in 2024, while citalopram has fallen 58% since 2014 [4]. Nothing in a 2010 marketing case changes your prescription by itself. The two questions it sharpens: for anyone on high-dose citalopram, “does the 2011 QT dosing change apply to me?” — and for a teenager’s prescription, “what does the approved-indication evidence actually say for this age?” — both questions for your prescriber, both better asked than assumed in either direction.

Common questions

What did Forest Laboratories plead guilty to in 2010?

Three things, and the precision matters: obstruction of justice — concerning its thyroid drug Levothroid, not the antidepressants; distributing misbranded Levothroid; and the illegal off-label promotion of Celexa for use in children and adolescents. The total resolution exceeded $313 million, including a $150 million criminal fine.

Was Lexapro part of the case?

Yes — in the civil settlement. The False Claims Act allegations Forest paid roughly $149 million to resolve covered both Celexa and Lexapro, including allegations that the company paid kickbacks to doctors — cash disguised as grants or consulting fees, meals, and entertainment — to induce prescribing. Civil settlements resolve allegations without a determination of liability, and that distinction is kept throughout this page.

What was the pediatric issue with Celexa?

Celexa was never approved for pediatric depression during the conduct period. The government alleged Forest promoted it for children and adolescents while publicizing a favorable study and not disclosing a contemporaneous negative European pediatric study. Escitalopram later received an FDA adolescent indication (2009) — the two facts coexist and this page states both.

Are there serious recalls for citalopram or escitalopram?

No Class I recall for either molecule in the openFDA enforcement database: eight records for citalopram, two for escitalopram, all Class II or III, all terminated. There is also a non-litigation safety fact worth knowing: in 2011-2012 the FDA revised citalopram dosing over QT-interval concerns, capping the recommended maximum dose — a label change, not a recall.

Does this record mean Lexapro or Celexa don’t work?

No. The 2010 case was about marketing conduct and disclosure, not efficacy in adults — in the largest network meta-analysis of antidepressants, escitalopram ranked among the better-performing drugs on effectiveness and acceptability. Corporate conduct and drug performance are separate questions; this page answers only the first and links the evidence for the second.

Sources

Last verified 2026-08-31. Corrections change this date.