FDA approvals and recalls

HIV: 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

  • Idvynso (doravirine, islatravir)

    Approved for: IDVYNSO™ is indicated as a complete two-drug regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral reg…

    NDA216964

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

Device recalls

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

At the source

  • Blood And Urine Collection Kit (Excludes Hiv Testing)

    Reason: The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. C…

    Z-3127-2026

  • Blood And Urine Collection Kit (Excludes Hiv Testing)

    Reason: Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of po…

    Z-3073-2026

  • Urine Collection Kit (Excludes Hiv Testing)

    Reason: An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March 31, 2027, instead of February 28, 2027.

    Z-0069-2027

  • Blood And Urine Collection Kit (Excludes Hiv Testing)

    Reason: The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to th…

    Z-3051-2026

  • Blood And Urine Collection Kit (Excludes Hiv Testing)

    Reason: The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to th…

    Z-3063-2026

  • Foley Catheter Kit (Excludes Hiv Testing)

    Reason: During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for…

    Z-2024-2026

  • Blood And Urine Collection Kit (Excludes Hiv Testing)

    Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol P…

    Z-2040-2026

  • Blood And Urine Collection Kit (Excludes Hiv Testing)

    Reason: Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.

    Z-1930-2026

  • Foley Catheter Kit (Excludes Hiv Testing)

    Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however…

    Z-1396-2026

  • Blood And Urine Collection Kit (Excludes Hiv Testing)

    Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however…

    Z-1403-2026

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

Side effects people report

25,224 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. 1Bone density decreased1,994 reports
  2. 2Renal failure1,431 reports
  3. 3Chronic kidney disease1,353 reports
  4. 4Pathogen resistance1,162 reports
  5. 5Bone loss1,160 reports
  6. 6Osteonecrosis1,147 reports
  7. 7Tooth loss1,095 reports
  8. 8Virologic failure1,073 reports
  9. 9Pain1,017 reports
  10. 10Injection site pain895 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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