Products Affected - Description

• • Labetalol injection, Baxter, 5 mg/mL, 20 mL vial, 1 count, NDC 36000-0322-02
  • Labetalol injection, Hikma, 5 mg/mL, 4 mL vial, 10 count, NDC 00143-9183-10
  • Labetalol injection, Hikma, 5 mg/mL, 40 mL vial, 1 count, NDC 00143-9623-01
  • 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

Reason for the Shortage

• • Almaject has discontinued labetalol injection.
  • Amneal has labetalol injection available.
  • Baxter has labetalol injection on shortage due to increased demand.
  • Caplin Steriles has labetalol injection available.
  • Fosun has labetalol injection available.
  • Hikma did not provide a reason for the shortage.
  • Pfizer has labetalol injection on shortage due to manufacturing delays.
  • Sagent did not provide a reason for the shortage.

Available Products

• • Labetalol injection, Amneal, 5 mg/mL, 4 mL syringe, 24 count, NDC 70121-2428-03
  • Labetalol injection, Baxter, 5 mg/mL, 4 mL vial, 10 count, NDC 36000-0320-10
  • Labetalol injection, Baxter, 5 mg/mL, 40 mL vial, 1 count, NDC 36000-0324-02
  • Labetalol injection, Caplin Steriles USA, 5 mg/mL, 20 mL vial, 1 count, NDC 65145-0124-01
  • Labetalol injection, Caplin Steriles USA, 5 mg/mL, 40 mL vial, 1 count, NDC 65145-0125-01
  • 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, Hikma, 5 mg/mL, 20 mL vial, 1 count, NDC 00143-9622-01
  • Labetalol injection, Pfizer, 5 mg/mL, 20 mL vial, 25 count, NDC 00409-0125-25

• • Baxter has labetalol 5 mg/mL 20 mL vials available in limited supply.
  • Hikma has labetalol 5 mg/mL 4 mL vials on back order and the company estimates a release date of mid-July 2026. The 40 mL vials are on allocation.
  • Pfizer has labetalol 5 mg/mL 4 mL Carpuject syringes and 40 mL vials available in limited supply.
  • Sagent has labetalol 5 mg/mL 20 mL and 40 mL vials on back order and the company cannot estimate a release date.

• • Pfizer, in coordination with FDA, issued an Important Drug Warning Letter regarding a potential molding defect at the tip of the needle sheath. Visually examine Carpuject units prior to administration and discard any unit showing a hole at the tip of the needle sheath as shown in pictures at https://www.pfizerhospitalus.com/sites/default/files/news_announcements/Issued%20Carpuject%20DHCPL%2027MAR2026.pdf.