Products Affected - Description

• • Labetalol injection, Baxter, 5 mg/mL, 20 mL vial, 1 count, NDC 36000-0322-02
  • Labetalol injection, Baxter, 5 mg/mL, 4 mL vial, 10 count, NDC 36000-0320-10
  • Labetalol injection, Hikma, 5 mg/mL, 2 mL syringe, 10 count, NDC 00641-6252-10
  • Labetalol injection, Hikma, 5 mg/mL, 20 mL vial, 1 count, NDC 00143-9622-01
  • Labetalol injection, Hikma, 5 mg/mL, 40 mL vial, 1 count, NDC 00143-9623-01

Reason for the Shortage

• • Almaject has discontinued labetalol injection.
  • Baxter has labetalol injection on shortage due to increased demand.
  • Fosun has labetalol injection available.
  • Hikma did not provide a reason for the shortage. Hikma discontinued the premixed bags in mid-2023.
  • Pfizer has labetalol injection available.
  • Sagent has labetalol injection available.

Available Products

• • Labetalol injection, Baxter, 5 mg/mL, 40 mL vial, 1 count, NDC 36000-0324-02
  • Labetalol injection, Fosun Pharma, 5 mg/mL, 20 mL vial, 1 count, NDC 72266-0102-01
  • Labetalol injection, Fosun Pharma, 5 mg/mL, 40 mL vial, 1 count, NDC 72266-0103-01
  • Labetalol injection, Pfizer, 5 mg/mL, 20 mL vial, 25 count, NDC 00409-0125-25
  • Labetalol injection, Pfizer, 5 mg/mL, 4 mL Carpuject syringe, 10 count, NDC 00409-2339-34
  • Labetalol injection, Pfizer, 5 mg/mL, 40 mL vial, 1 count, NDC 00409-2267-54
  • Labetalol injection, Sagent, 5 mg/mL, 20 mL vial, 1 count, NDC 25021-0317-20
  • Labetalol injection, Sagent, 5 mg/mL, 40 mL vial, 1 count, NDC 25021-0317-40

• • Baxter has labetalol 5 mg/mL 4 mL vials and 20 mL vials available in limited supply.
  • Hikma has labetalol 5 mg/mL 20 mL vials on allocation. The 40 mL vials are on back order and the company estimates a release date of mid-May 2025. The 2 mL syringes are on back order and the company cannot estimate a release date.