Health Advisory: Penicillin G Benzathine (Bicillin® L- A) Recall and Shortage

August 28, 2025

CURRENT SITUATION:

On July 10, 2025, the drug manufacturer Pfizer announced a voluntary recall for multiple lot numbers of Penicillin G Benzathine (brand name Bicillin® L-A). Bicillin® L-A is an injectable antibiotic used to treat syphilis and other types of bacterial infections; it is the only medication available to treat syphilis for certain groups of patients, including pregnant people and babies.

To date, there have been no reported adverse events associated with this recall. There is no indication that recalled medication is less effective if it has been administered, and no further action has been advised with regard to patients who have already received doses from the recalled lots. 

As a result of this recall, Bicillin® L-A is now on the FDA drug shortage list. Pfizer does not currently have a timeline for when Bicillin® L-A will be readily available again. Because cases of syphilis are still high in Washington (and across the U.S.), providers should prepare for the possibility of an extended shortage.

ACTIONS REQUESTED:

Healthcare providers, clinics, and other facilities in Washington are requested to do the following:

• Monitor inventory of Bicillin® L-A and begin prioritizing Bicillin® L-A doses to ensure treatment is available for pregnant people and other priority groups.
  1. Bicillin® L-A is the only acceptable treatment for pregnant people and babies diagnosed with or exposed to syphilis.
  2. Prioritization recommendations for Bicillin® L-A:
     • Pregnant people diagnosed with or exposed to syphilis
     • Babies with congenital syphilis or who have been exposed to syphilis
     • People allergic to Doxycycline
     • People with early syphilis who may not adhere to doxycycline treatment
     • People living with HIV
     • Individuals who have already initiated treatment with a 3-week course of Bicillin® L-A
• Continue to test patients for syphilis.
  1. Follow Washington syphilis reporting guidelines and CDC STI Treatment Guidelines to guide accurate staging of syphilis cases.
  2. In addition, if syphilis is suspected or confirmed, test for HIV if the patient’s HIV status is not already known.
• Test any (pregnancy-capable) patient diagnosed with syphilis for pregnancy.
• Immediately move to treating non-pregnant cases of syphilis with doxycycline.
  1. Ensure patients can adhere to the recommended doxycycline regimen and provide medication counseling to ensure treatment completion.
  2. Follow Doxycycline dosing recommendations for syphilis based on the stage of syphilis:
     • Early syphilis (primary, secondary, or early latent): Doxycycline 100mg by mouth twice daily for 14 days.
     • Late syphilis (late latent or unknown duration): Doxycycline 100mg by mouth twice daily for 28 days.
• Continue to assess for and treat complicated syphilis (neuro-, oto-, and ocular syphilis) per CDC guidelines, as this issue does not affect treatment for these types of syphilis.
• When possible, utilize other antibiotics for treatment of other types of infections (such as strep throat or rheumatic fever) in order to preserve Bicillin® L-A for use in priority groups of patients diagnosed with Syphilis.

BACKGROUND:

Syphilis is a sexually transmitted infection which causes systemic disease. It is caused by the bacterium Treponema pallidum. The disease has been divided into stages on the basis of clinical findings, which guide treatment and follow-up. Persons who have syphilis might seek treatment for signs or symptoms. Primary syphilis classically presents as a single painless ulcer or chancre at the site of infection but can also present with multiple, atypical, or painful lesions. Secondary syphilis manifestations can include skin rash, mucocutaneous lesions, and lymphadenopathy. Tertiary syphilis can present with cardiac involvement, gummatous lesions, tabes dorsalis, and general paresis.

Latent infections (i.e., those lacking clinical manifestations) are detected by serologic testing. Latent syphilis acquired within the preceding year is referred to as early latent syphilis; all other cases of latent syphilis are classified as late latent syphilis or latent syphilis of unknown duration. Serologic testing for syphilis requires a nontreponemal test (the rapid plasma regain, or RPR) test with a titer and a treponemal test (typically EIA or TP-PA) to confirm infection. Serology may in rare cases be negative within approximately the first week of the appearance of the primary chancre. People who have previously been treated for syphilis will continue to have positive serology with a reduction in RPR titer post-treatment.

The first line treatment for syphilis is Penicillin G Benzathine (Bicillin® L-A). It is administered once (2.4 million units intramuscular) for primary, secondary, and early latent syphilis, and once weekly for three weeks for latent syphilis of unknown duration or late latent syphilis. The second line treatment is doxycycline 100 mg, taken orally twice daily for two weeks for primary, secondary, and early non-primary non-secondary syphilis, and for four weeks for latent syphilis of unknown duration or late latent syphilis. Complicated syphilis requires further testing and is treated with a different form of penicillin that is administered intravenously.

RESOURCES:

1. National STD Curriculum: Syphilis (Self-paced learning module, includes CE)
2. CDC STI Treatment Guidelines: Syphilis
3. Pfizer Urgent Drug Recall Notice: Bicillin® L-A (PDF)
4. WA DOH Notifiable Conditions: Syphilis (Includes reporting requirements for providers)

CONTACT:

To report suspected cases, for questions about staging a syphilis case, or for any other questions, please contact:

Snohomish County Health Department 

(425) 339-5261 

https://www.snohd.org/185/Sexually-Transmitted-Infections

Report a case via this form.

For questions: SHD-STDinfo@co.snohomish.wa.us

Providers may also contact the appropriate regional Washington Department of Health Field Staff based on the location of their clinic or healthcare facility.