FDA approvals and recalls

Skin and hair: 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

3 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

  • Ebglyss (lebrikizumab-lbkz)

    Approved for: EBGLYSS is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg whose disease is…

    BLA761306

  • Leqselvi (deuruxolitinib phosphate)

    Approved for: LEQSELVI ® is indicated for the treatment of adult patients with severe alopecia areata. Limitations of Use LEQSELVI is not recommended for use in combination with other JAK inhib…

    NDA217900

  • Litfulo (ritlecitinib)

    Approved for: LITFULO is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older. Limitations of Use : Not recommended for use in c…

    NDA215830

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

Drug recalls

23 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

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

At the source

  • Implant, Cochlear

    Reason: Due to a manufacturing deviation of incomplete electrode welds of cochlear implants and resulting in one or more open circuits

    Z-0349-2027

  • Calculator, Drug Dose

    Reason: A software defect in which existing users who had previously configured and enabled the long-acting dose reminder feature in version 1.2.0 or earlier experienced failure of the long-acting dose remin…

    Z-0265-2027

  • Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

    Reason: Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP).

    Z-3258-2026

  • Skin Prep Tray

    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-3074-2026

  • Introducer, Catheter

    Reason: Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.

    Z-2930-2026

  • Skin Prep Tray

    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-3058-2026

  • Interventional Fluoroscopic X-Ray System

    Reason: Due to a defective circuit board that overheats

    Z-2857-2026

  • Implant, Cochlear

    Reason: Due to incorrect shelf-life expiration date.

    Z-2283-2026

  • Agent, Absorbable Hemostatic, Collagen Based

    Reason: Potential for product to contain foreign matter, confirmed to be inspect fragments.

    Z-1896-2026

  • Skin Prep Tray

    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-2044-2026

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

510(k) clearances

110 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

231,292 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. 1Dermatitis atopic38,038 reports
  2. 2Pruritus37,955 reports
  3. 3Rash20,634 reports
  4. 4Dry skin19,036 reports
  5. 5Eczema15,258 reports
  6. 6Injection site pain13,742 reports
  7. 7Skin exfoliation10,347 reports
  8. 8Erythema7,849 reports
  9. 9Arthralgia6,751 reports
  10. 10Therapeutic response shortened6,269 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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