Skip Navigation LinksUpdate-on-Bicillin-L-A-Shortage-Drug-Recall-Inventory-Review-and-Clinical-Guidance Update on Bicillin L-A Shortage: Drug Recall, Inventory Review, and Clinical Guidance

State of Cal Logo
GAVIN NEWSOM
Governor

State of California—Health and Human Services Agency
California Department of Public Health


​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​ ​​​​​​​​​​​​​​​​​​​​​​​ ​​​​​​​​​​​​​​​​​​​                                                        ​​Health Update                                       ​​                ​​​​​​    ​​​

TO: Healthcare Providers
Update on Bicillin® L-A Shortage: Drug Recall, Inventory Review, and Clinical Guidance
7/24/2025



​Key Messages:

  • There is a voluntary recall for select lots (PDF) of Bicillin® L-A (penicillin G benzathine injectable suspension) and limited availability of the drug for the treatment of syphilis.

  • Healthcare providers and entities should continue to prioritize long-acting penicillin-based treatments (Bicillin® L-A, Extencilline®, & Lentocilin®) for the treatment of pregnant people with syphilis and infants exposed to syphilis in utero.

  • Oral doxycycline is an acceptable alternative treatment for non-pregnant adults with primary, secondary, early/late latent syphilis and syphilis of unknown duration.​

  • If sufficient supplies of long-acting penicillin-based medications are available, consider offering this treatment to people who may have difficulty completing the full doxycycline regimen.


​Background

In 2023-2024, the U.S. Food & Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) reported a Bicillin® L-A shortage which led to increased production of the drug and temporary importation of alternative, equivalent products, Extencilline® and Lentocilin®. On July 10, 2025, Pfizer issued a voluntary recall for multiple lots of Bicillin® L-A (PDF) (1.2 and 2.4 MU doses) distributed between 12/1/23 - 6/24/25 due to particulates in the syringes. To date, CDC and Pfizer have not received reports of adverse events associated with this issue and there is no indication at this time of reduced efficacy or need for retreatment. Most recently on July 14, 2025, FDA issued a drug shortage alert describing limited availability of these Bicillin® L-A products.

CDPH Recommendations and Prioritization Guidance:

Healthc​are providers should closely review their inventory and discontinue use, stop distribution, and quarantine affected lots (PDF 1.2MB) immediately.  

As a reminder, Benzathine penicillin G is the only known effective antimicrobial for treating syphilis in pregnancy and preventing congenital syphilis. If you are experiencing a Bicillin® L-A drug shortage, the California Department of Public Health (CDPH) recommends the use of Bicillin ® L-A and equivalent products in the following populations:

  1. ​​​Pregnant people with syphilis infection (or exposure) as well as for infants exposed to syphilis in utero; ​and

  2. Patients with contraindications to doxycycline (e.g., anaphylaxis, hemolytic anemia, Stevens Johnson syndrome).

For people with syphilis who do not meet the above criteria, oral doxycycline is an acceptable alternative, including:

  • ​Doxycycline 100 mg PO twice a day x 14 days for treatment of early (primary, secondary, or early latent) syphilis

  • Doxycycline 100 mg PO twice a day x 28 days for treatment of lat​e latent syphilis or syphilis of unknown duration

This guidance does not preclude clinical judgement in situations in which patients may benefit from treatment with long-acting penicillin-based medications.

If adequate supplies are available, consider offering Bicillin® L-A instead of doxycycline for people who may have difficulty completing the full doxycycline regimen -- for example, people experiencing homelessness. If such patients are staged as having syphilis of late latent/unknown duration, clinicians may also consider initiating a dose of Bicillin® L-A​ in addition to 28 days of twice-daily doxycycline. This strategy may help patients complete treatment and treat unrecognized early syphilis.

CDPH also recommends conservation of Bicillin® L-A by using alternative drugs for the treatment of infectious diseases (e.g., streptococcal pharyngitis) where oral medications or other effective antimicrobials are available.

Clinicians should refer to CDC and CDPH STI treatment guidelines for alternative syphilis treatment options as well as the following CDC and previous CDPH communications for guidance on Bicillin® L-A prioritization and use of alternative treatment options for non-pregnant people when necessary to preserve Bicillin® L-A​ ​supplies:​

Approved Alternative Penicillin Products

Extencilline® and Lentocilin® are available and have been appr​​​oved by FDA for temporary importation due to prior Bicillin® L-A shortages. Both are safe for use in pregnant patients and should be administered following standard protocols for treatment of syphilis in pregnancy (PDF). Please note that the preparation and administration of Extencilline® and Lentocilin® differ from those for Bicillin® L-A. CDPH has previous posted a Dear Colleague Letter on the Use of Extencilline® for the Treatment of Syphilis.​

Res​​​ources