Pfizer has announced a recall of certain batches of Bicillin L-A, a long-acting penicillin injection used to treat syphilis during pregnancy. The recall, issued on July 10, was due to contamination with floating particles. Although no adverse effects have been reported, Pfizer warns that supply shortages may worsen until the issue is resolved.
Bicillin L-A, or benzathine penicillin G, is the only approved treatment for syphilis in pregnant women. A single injection can prevent the infection from passing to the baby, which can otherwise cause stillbirths, bone deformities, or hearing and vision problems in newborns. Rising syphilis cases among adults have led to a 700% increase in congenital syphilis in babies over the last decade, according to the US Centers for Disease Control and Prevention (CDC).
Pfizer, the sole US supplier of Bicillin, began rationing the drug in 2023. To prioritize pregnant patients, it stopped producing pediatric doses. During shortages, the US Food and Drug Administration (FDA) has approved imports of similar products like Extencilline from France and Lentocilin from Portugal. However, these alternatives are challenging for hospitals to use due to different labeling and mixing instructions.
Health systems in states like New Mexico and Minnesota have been actively testing and treating pregnant women for syphilis during routine visits. This one-stop treatment approach had recently slowed the rising infection rates. Experts fear that the recall may reverse this progress.
Pfizer has assured that it is addressing the issue and will update customers on supply status by mid-August. Until then, doses will be rationed and distributed per patient request.
The recall has alarmed public health organizations like the National Coalition of STD Directors, which reports that states are returning hundreds of vials of Bicillin. Experts warn that the shortage, combined with recent federal funding cuts to STD programs, could undermine testing and treatment efforts nationwide.
The CDC is expected to release updated guidelines for managing syphilis during the shortage, while public health leaders continue to push for stronger emergency measures.
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