FDA approvals and recalls

Mental health: FDA Approvals, Recalls, 510(k) Clearances and Side Effect Reports

What the US Food and Drug Administration has cleared, approved and recalled on this topic, and the side effects people report.

Each number has its full source under its own list below.

New drug approvals

2 new medicines approved (since 1 Jan 2023). Medicines with a new active ingredient that the FDA approved, whose label lists a use on this topic.

At the source

  • Flyrcado (flurpiridaz f-18)

    Approved for: FLYRCADO is indicated for positron emission tomography (PET) myocardial perfusion imaging (MPI) under rest or stress (pharmacologic or exercise) in adult patients with known or su…

    NDA215168

  • Zurzuvae (zuranolone)

    Approved for: ZURZUVAE is indicated for the treatment of postpartum depression (PPD) in adults. ZURZUVAE is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator in…

    NDA217369

Source: openFDA, Novel drug approvals (new molecular entities and new biologics), since 1 Jan 2023. Retrieved 12 Nov 2026.

Drug recalls

41 recalls (since 1 Jan 2023). Recalls of medicines for this topic, newest first.

At the source

Source: openFDA, Drug recall enforcement reports, since 1 Jan 2023. Retrieved 12 Nov 2026.

Device recalls

7 recalls (since 1 Jan 2023). Recalls of medical devices for this topic, newest first.

At the source

  • Electrocardiograph

    Reason: There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies sole…

    Z-0321-2025

  • Electrocardiograph

    Reason: There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies sole…

    Z-0325-2025

  • Osmometer For Clinical Use

    Reason: System error messages may delay the ability to test patient samples and the need for frequent calibration due to results outside the expected range when testing controls.

    Z-1696-2024

  • Electrocardiograph

    Reason: Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.

    Z-0705-2024

  • Electrocardiograph

    Reason: Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.

    Z-0706-2024

  • Electrocardiograph

    Reason: Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.

    Z-0707-2024

  • Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety

    Reason: If the batteries are installed incorrectly, the product may overheat, possibly leading to pain, discomfort, irritation, or even burns during use of the device.

    Z-1600-2023

Source: openFDA, Medical device recalls, since 1 Jan 2023. Retrieved 12 Nov 2026.

510(k) clearances

2 devices cleared (since 1 Jan 2023). Devices the FDA cleared to sell in the US, newest first.

At the source

Source: openFDA, Premarket notifications (510(k)) cleared, since 1 Jan 2023. Retrieved 12 Nov 2026.

Side effects people report

81,189 side effect reports (reports received since 1 Jan 2023). The reactions named most often in reports about medicines used for this topic.

At the source
  1. 1Nausea5,191 reports
  2. 2Anxiety4,287 reports
  3. 3Dizziness3,793 reports
  4. 4Fatigue3,703 reports
  5. 5Vomiting3,358 reports
  6. 6Suicidal ideation3,332 reports
  7. 7Dissociation3,117 reports
  8. 8Depression3,110 reports
  9. 9Headache3,084 reports
  10. 10Diarrhoea2,980 reports

Anyone can send a report. A report does not prove that the medicine caused the reaction, and the counts do not show how often it happens.

Source: openFDA, FDA Adverse Event Reporting System (FAERS), reports by reaction, reports received since 1 Jan 2023. Retrieved 12 Nov 2026.

Benchmarks on mental health

Countries side by side on public measures for this topic.

All benchmarks

Market reports on mental health

Search all
OTC & Nutraceuticals

Adaptogens

Worldwide · 2024–2034

View report Pharmaceuticals

ADHD Drugs

Worldwide · 2024–2034

View report Public Health

Adolescent Mental Health Public Health Report

Worldwide · 2024–2034

View report Digital Health

Adult ADHD Telehealth

Worldwide · 2024–2034

View report Digital Health

AI in Mental Health

Worldwide · 2024–2034

View report Public Health

Alcohol Use Disorders Public Health Report

Worldwide · 2024–2034

View report

From our blog

All stories

Adaptogens: Ancient Herbs, Modern Market

170 WHO Member States report the use of traditional medicine. Adaptogens like ashwagandha, rhodiola and…

Read

Stress and Mood Supplements: Ashwagandha and Beyond

Depression and anxiety cost the world about US$1 trillion a year. Ashwagandha has some evidence for stress…

Read

Antidepressants: Demand, Access and New Approaches

About 322 million people live with depression. Treatment works, but most people still do not get it.

Read

FDA approvals and recalls on related topics

All topics

Acuitas market sizes and forecasts are only in our full reports. How we use public data.