FDA approvals and recalls

Influenza: 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

2 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

16 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

57 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

11,634 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. 1Cough1,078 reports
  2. 2Dyspnoea772 reports
  3. 3Vomiting648 reports
  4. 4Nausea637 reports
  5. 5Diarrhoea636 reports
  6. 6Dizziness486 reports
  7. 7Pneumonia442 reports
  8. 8Fatigue440 reports
  9. 9Headache437 reports
  10. 10Pyrexia343 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 influenza

Countries side by side on public measures for this topic.

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Market reports on influenza

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OTC & Nutraceuticals

Antipyretics OTC

Worldwide · 2024–2034

View report Public Health

Avian Influenza (H5N1) Public Health Report

Worldwide · 2024–2034

View report Pharmaceuticals

Influenza Antivirals

Worldwide · 2024–2034

View report Public Health

Influenza Vaccination Public Health Report

Worldwide · 2024–2034

View report OTC & Nutraceuticals

Over The Counter (OTC) Medications for Cough, Cold & Flu Drugs

Worldwide · 2024–2034

View report Public Health

Seasonal Influenza Public Health Report

Worldwide · 2024–2034

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