11/3/2024

Labetalol Injection

Products Affected - Description

- Labetalol injection, Almaject, 5 mg/mL, 20 mL vial, 1 count, NDC 72611-0734-01 - discontinued
- Labetalol injection, Almaject, 5 mg/mL, 40 mL vial, 1 count, NDC 72611-0738-01 - discontinued
- 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
- Labetalol injection, Sagent, 5 mg/mL, 20 mL vial, 1 count, NDC 25021-0317-20

Reason for the Shortage

- Almaject has discontinued labetalol injection.
- Baxter has labetalol injection available.
- 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 on shortage due to manufacturing delays.
- Sagent did not provide a reason for the shortage.

Available Products

- 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, 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, 40 mL vial, 1 count, NDC 25021-0317-40

Estimated Resupply Dates

- 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 late-December 2024 to early-January 2025. The 2 mL syringes are on back order and the company cannot estimate a release date.
- Sagent has labetalol 5 mg/mL 20 mL vials on back order and the company estimates a release date of November 2024.

Updated

Updated November 3, 2024 by Michelle Wheeler, PharmD, Drug Information Specialist. Created January 19, 2022 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2024, Drug Information Service, University of Utah, Salt Lake City, UT.

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