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

• 1new drug approvals (since 1 Jan 2023)
• 1drug recalls (since 1 Jan 2023)
• 2device recalls (since 1 Jan 2023)
• 15,052side effect reports (reports received since 1 Jan 2023)

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

• 29Aug2025

  Wayrilz (rilzabrutinib)

  Approved for: WAYRILZ is indicated for the treatment of adult patients with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. WA…

  NDA219685

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

• 19Aug2026

  Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Only, For Intramuscular Use Only, Mfd. by Chiesi USA, Inc., Cary, NC 2751…

  Reason: Failed Stability Specifications: Out of specification stability result for the protein concentration profile.

  D-0838-2026

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

• 17Aug2026

  Multi-Analyte Controls, All Kinds (Assayed)

  Reason: Vial-to-vial variability in MAS Omni"IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, Lot OPRO29061A results in low Parathyroid Hormone (PTH) recovery, which may lead to a delay in…

  Z-0159-2027
• 6Sep2023

  Transferrin, Rhodamine, Antigen, Antiserum, Control

  Reason: The firm has identified that the Transferrin reagent does not meet the Instructions for Use (IFU) reagent on-board stability claims, which may cause control failures and/or erroneous patient samples…

  Z-0309-2024

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

1. 1Platelet count decreased1,771 reports
2. 2Diarrhoea1,012 reports
3. 3Headache728 reports
4. 4Fatigue661 reports
5. 5Hereditary angioedema651 reports
6. 6Nausea537 reports
7. 7Platelet count increased496 reports
8. 8Pneumonia411 reports
9. 9Immune thrombocytopenia408 reports
10. 10Weight increased397 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.

• Skin and hair
• Bones and joints
• Allergies