Bicillin L-A® Pfizer Recall and Anticipated Shortage in Virginia

Bicillin L-A® Pfizer Recall and Anticipated Shortage in Virginia

24de julio de 2025

Estimado colega:

On July 10, 2025, Pfizer subsidiary King Pharmaceuticals announced a voluntary recall of select Bicillin L-A® (penicillin G benzathine) lots, due to the presence of particulates in the syringes.  While the manufacturer indicates that no adverse effects have been reported to date, and many of the lots may have already been distributed to providers and administered, the remaining affected doses should not be used.  For recalled doses already administered to patients, providers should use their standard protocols to determine the approach for action. Pfizer has provided detailed instructions for identifying the impacted lots, returning the product and obtaining reimbursement, as well as medical request process instructions for customers.  Pfizer has indicated they will provide an updated situation report no later than mid-August.

Bicillin L-A® is the only recommended treatment for pregnant women and babies with congenital syphilis.  There are no emergency stockpiles of this medication, and product is being allocated on a case-by-case basis.  Providers should work with their supplier or Pfizer directly regarding product availability. This recall and ongoing shortages of Bicillin L-A® are occurring during a period of increased syphilis incidence in Virginia.  Reported cases of syphilis were 76% higher in 2024 (3,317 cases) compared to 2020 (1,880 cases). Syphilis infections during pregnancy resulted in 35 congenital syphilis cases last year, the highest case count in over 30 years.

 CDC has recommended that healthcare providers prioritize the use of Bicillin L-A® to treat pregnant women, infants and neonates with congenital syphilis. VDH Central Pharmacy currently has adequate Bicillin L-A® to treat all patients with syphilis. We are closely monitoring our supply. VDH recommends providers observe the CDC recommendation by taking the following actions: 

  • Providers whose remaining supply of Bicillin L-A® will be depleted before August 15, 2025, are encouraged to begin using doxycycline to treat all male and non-pregnant female patients.
  • Healthcare providers treating high-risk pregnant women diagnosed with or exposed to syphilis can work with the local health department to coordinate care and refer patients for proper treatment. Community providers who have difficulty accessing Bicillin L-A® can also submit requests to have medication dispensed from VDH for each pregnant patient and others who cannot use an alternative treatment.
  • Pregnant women should be treated with the recommended penicillin regimen for their stage of infection.
  • Doxycycline can be used to treat non-pregnant adult patients diagnosed with or exposed to syphilis. Educate patients receiving doxycycline as an alternative treatment on the importance of adherence. 
  • The recommended course of treatment for early syphilis (less than one year of duration) is doxycycline 100 mg by mouth, twice daily for 14 days.
  • The recommended course for late latent or syphilis of unknown duration is doxycycline 100mg by mouth, twice daily for 28 days.
  • Providers can also consider alternative, temporarily imported products, including Extencilline and Lentocilin©. Use of other intramuscular formulations of penicillin, including Bicillin C-R, are not acceptable alternatives for the treatment of syphilis.
  • Thorough clinical and serologic follow-up of persons receiving doxycycline or other alternative therapies for syphilis is essential to ensure successful treatment. Patients should be followed to confirm that a fourfold decrease in non-treponemal (RPR) titer is achieved within six to twelve months of completing treatment.  Patients who have had sexual exposures within the past 90 days to partners with an early syphilis diagnosis should be treated presumptively for early syphilis.  Presumptive treatment should also be considered for more distant sexual exposures if serologic test results are not immediately available and the opportunity for follow-up is uncertain.
  • Accurately stage syphilis cases to ensure appropriate use of antimicrobials. Early syphilis (primary, secondary, and early latent) only requires one dose of 2.4 million units of Bicillin® L-A, including during pregnancy.  See the CDC STI Treatment Guidelines.
  • Bicillin L-A® is one of the preferred prophylactic regimens for patients with acute rheumatic fever or rheumatic heart disease to reduce the likelihood of recurrent Streptococcal infections and acute rheumatic fever episodes. Twice daily administration of oral penicillin V is an alternative option for prophylaxis as detailed in CDC’s Clinical Guidance for Acute Rheumatic Fever.
  • Use alternatives to Bicillin L-A to treat other infectious diseases (such as streptococcal pharyngitis) if other treatment options are available.
  • Consider talking to patients who are eligible about doxycycline as post-exposure prophylaxis (DoxyPEP) to prevent syphilis. DoxyPEP has been shown in clinical trials and observational studies to reduce new syphilis infections by more than 80% in high-risk populations.
  • Patients who are coinfected with HIV can be treated the same as recommended for patients who do not have HIV.

Additional Resources and Reference Materials for Clinicians:

 

Thank you for your partnership in disease treatment and prevention, as we strive to reduce syphilis and eliminate congenital syphilis in Virginia.

Atentamente,

Dra. Karen Shelton
Comisionado Estatal de Salud

 

Última actualización: 24 de julio de 2025