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

• 3new drug approvals (since 1 Jan 2023)
• 2drug recalls (since 1 Jan 2023)

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

• 6Jun2024

  Rytelo (imetelstat sodium)

  Approved for: 1. INDICATIONS AND USAGE RYTELO is indicated for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia…

  NDA217779
• 27Mar2024

  Vafseo (vadadustat)

  Approved for: VAFSEO is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Limitations of Use VAFSEO…

  NDA215192
• 1Feb2023

  Jesduvroq (daprodustat)

  Approved for: JESDUVROQ is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least four months. Limitations of Use JESD…

  NDA216951

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

• 24Jul2026

  Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use Only, packaged in a) 10 mL Multi-Dose Vial (NDC 0517-0032-01) and b) 25x10 mL M…

  Reason: Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

  D-0793-2026
• 24Jul2026

  Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged in a) 1 mL Multi-Dose Vial (NDC 0517-0031-01), and b) 25x1 mL Multi-Dose Vials (NDC…

  Reason: Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

  D-0792-2026

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

• Anaemia in women 15–49

• Pediatric
• Maternal
• Diagnostics and lab testing
• Women's health