Critical shortage of syphilis drug threatens pregnant women, babies
The only U.S.-made drug to prevent mothers from passing syphilis to babies remains in critical shortage, with normal supplies not expected until late 2027.
RALEIGH, NORTH CAROLINA — A nationwide shortage of the only first-line medication used to prevent pregnant women from passing syphilis to their babies continues to affect the United States, with supplies not expected to return to normal until December 2027.
Drug manufacturer Pfizer issued a voluntary recall of Bicillin L-A, or penicillin G benzathine, in July 2025 after discovering particulates or foreign material in some batches of the long-acting injectable antibiotic. The U.S. Food and Drug Administration confirmed that normal supply levels will not resume for another 18 months.
The shortage comes as congenital syphilis rates have been rising across the country, creating a significant public health challenge for pregnant women and newborns who depend on this medication for treatment and prevention.
Single Manufacturing Source Creates Vulnerability
The United States relies on just one manufacturing plant for this injectable penicillin, operated by Pfizer’s subsidiary King Pharmaceuticals in Michigan. This monopoly has left the country vulnerable to supply disruptions when production issues arise.
The FDA has temporarily approved the importation of an alternative medication called Lentocilin from Portugal to help address the shortage. However, this imported substitute is not considered a permanent solution to the supply crisis.
“Because Lentocilin isn’t a permanent solution, and penicillin is difficult and complex to manufacture, experts are concerned that the shortage will worsen infection rates and the disparities associated with congenital syphilis,” according to health officials.
Recurring Supply Problems
Elizabeth Finley, interim executive director of the National Coalition of STD Directors, said Bicillin L-A has experienced intermittent shortages throughout the past decade. A 2023 survey conducted by her organization across 13 states during a previous shortage revealed widespread challenges in obtaining the drug for treating pregnant patients.
“A shortage that is more significant than we’ve experienced in the past,” Finley said, describing the current situation following last year’s recall.
The recall forced some health centers to lose their entire stock of Bicillin, compounding the supply challenges. The medication has no generic alternative available in the United States market.
State Response and Patient Priority
State health departments have implemented emergency protocols to manage the limited supply, guiding healthcare providers to prioritize the medication for pregnant patients with syphilis and their babies. Health departments are also working to connect patients with available drugs when local clinics lack sufficient supplies.
Congenital syphilis occurs when the infection passes from mother to developing fetuses and newborns, potentially causing devastating and irreversible health effects for babies. The shortage threatens to worsen existing health disparities associated with the condition.
Healthcare experts warn that the manufacturing complexity of penicillin, combined with the single-source production model, creates ongoing risks for future supply disruptions that could impact vulnerable populations who depend on this essential medication.
