FDA approvals and recalls

Maternal: 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.

Drug recalls

6 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

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

At the source

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

510(k) clearances

20 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

5,181 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. 1Foetal exposure during pregnancy2,837 reports
  2. 2Premature baby1,103 reports
  3. 3Maternal exposure during pregnancy896 reports
  4. 4Low birth weight baby431 reports
  5. 5Congenital anomaly401 reports
  6. 6Exposure during pregnancy300 reports
  7. 7Premature delivery295 reports
  8. 8Exposure via breast milk287 reports
  9. 9Foetal growth restriction220 reports
  10. 10Nausea128 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 maternal

Countries side by side on public measures for this topic.

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Market reports on maternal

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Public Health

Adolescent Pregnancy Public Health Report

Worldwide · 2024–2034

View report Public Health

Afghan Population Health Public Health Report

Worldwide · 2024–2034

View report Public Health

Antenatal Care Coverage Public Health Report

Worldwide · 2024–2034

View report Public Health

Birth Spacing Public Health Report

Worldwide · 2024–2034

View report Medical Devices

Breast Pumps

Worldwide · 2024–2034

View report Public Health

Caesarean Section Access Public Health Report

Worldwide · 2024–2034

View report

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