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

• 2drug recalls (since 1 Jan 2023)
• 3device recalls (since 1 Jan 2023)
• 5,023side effect reports (reports received since 1 Jan 2023)

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

• 5Jan2024

  Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupi…

  Reason: Subpotent Drug and Failed Impurities/Degradation Specifications

  D-0283-2024
• 5Jan2024

  Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupi…

  Reason: Subpotent Drug and Failed Impurities/Degradation Specifications

  D-0284-2024

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

• 5Nov2025

  System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen

  Reason: Product testing did not meet expected stability criteria.

  Z-0724-2026
• 20May2025

  Susceptibility Test Powders, Antimycobacterial

  Reason: BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis isolates.

  Z-2023-2025
• 18Jul2024

  Susceptibility Test Powders, Antimycobacterial

  Reason: May intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility testing of Mycobacterium tuberculosis isolates.

  Z-2686-2024

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

1. 1Neuropathy peripheral270 reports
2. 2Anaemia268 reports
3. 3Drug reaction with eosinophilia and systemic symptoms225 reports
4. 4Nausea205 reports
5. 5Drug-induced liver injury198 reports
6. 6Electrocardiogram qt prolonged177 reports
7. 7Vomiting170 reports
8. 8Hepatic cytolysis150 reports
9. 9Tuberculosis145 reports
10. 10Pyrexia131 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.

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