FDA approvals and recalls

Antibiotics: 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

1 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

  • Rezzayo (rezafungin)

    Approved for: REZZAYO is an echinocandin antifungal indicated in adults and pediatric patients 12 years of age or older who have limited or no alternative options for the treatment of candidemi…

    NDA217417

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

Drug recalls

8 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

83 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

25 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

16,498 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. 1Acute kidney injury705 reports
  2. 2Neutropenia627 reports
  3. 3Pyrexia581 reports
  4. 4Febrile neutropenia533 reports
  5. 5Septic shock425 reports
  6. 6Pneumonia419 reports
  7. 7Multiple organ dysfunction syndrome413 reports
  8. 8Diarrhoea393 reports
  9. 9Maternal exposure during pregnancy392 reports
  10. 10Drug reaction with eosinophilia and systemic symptoms388 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 antibiotics

Countries side by side on public measures for this topic.

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Market reports on antibiotics

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Pharmaceuticals

Aminoglycosides

Worldwide · 2024–2034

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Antibiotic Stewardship Public Health Report

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Antimicrobial Alternatives for Livestock

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Antimicrobial Resistance Diagnostics

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Antimicrobial Resistance Public Health Report

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Antimicrobial Susceptibility Testing

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