Products Affected - Description

• • Bleomycin sulfate lyophilized powder for solution for injection, Fresenius Kabi, 30 unit, vial, 1 count, NDC 63323-0137-20
  • Bleomycin sulfate, Hikma, 15 unit, vial, 1 count, NDC 00143-9240-01
  • Bleomycin sulfate lyophilized powder for solution for injection, Pfizer, 15 unit, vial, 1 count, NDC 61703-0332-18
  • Bleomycin sulfate lyophilized powder for solution for injection, Pfizer, 30 unit, vial, 1 count, NDC 61703-0323-22

Reason for the Shortage

• • Fresenius Kabi did not provide a reason for the shortage.
  • Hikma did not provide a reason for the shortage.
  • Meitheal has bleomycin injection available.
  • Pfizer has bleomycin injection on shortage due to manufacturing delays. In mid-2026, heavy rains flooded a key manufacturing facility in Gujarat, India.

Available Products

• • Bleomycin sulfate lyophilized powder for solution for injection, Fresenius Kabi, 15 unit, vial, 1 count, NDC 63323-0136-10
  • Bleomycin sulfate, Meitheal Pharmaceuticals, 15 unit, vial, 1 count, NDC 71288-0106-10
  • Bleomycin sulfate, Meitheal Pharmaceuticals, 30 unit, vial, 1 count, NDC 71288-0107-20

• • Hikma has bleomycin 15 unit vials on allocation. Bleomycin 30 unit vials are on back order and the company estimates a release date in late-December 2026.
  • Fresenius Kabi has bleomycin 30 unit vials on back order and the company estimates a release date in mid-October 2026.
  • Pfizer has bleomycin 15 unit vials in limited supply and the company estimates supply will be depleted in 2nd quarter to 3rd quarter 2027. Bleomycin 30 unit vials are also in limited supply and the company estimates supply will be depleted in 1st quarter 2027. Once supply is depleted, product is not expected to be available throughout the remainder of 2027.

• • Consider evaluating the health-care system's total supply of bleomycin before beginning patients on combination chemotherapy regimens containing bleomycin. If adequate supplies are not available, select an alternative regimen.
  • The choice of an alternative agent must be patient-specific and based on renal function, liver function, and the neoplasm type and location. No single agent can be substituted for bleomycin.
  • Consult a Hematology/Oncology specialist for patient- and neoplasm-specific recommendations.
  • Refer to the ASHP Infographics on Drug Product Shortages for more guidance on developing a multidisciplinary plan when the supply must be allocated. https://www.ashp.org/-/media/assets/drug-shortages/docs/ASHP-drug-shortages-infographic.pdf?rev=8c909ada5cfb4f05a28d5452eb57dd16
  • Refer to national guidelines such as those from the National Comprehensive Cancer Network (www.nccn.org) or American Society of Clinical Oncology (http://www.asco.org/) for additional information regarding therapeutic use.