

Pfizer's recall of Bicillin L-A has left the U.S. without reliable access to the only proven treatment for syphilis in pregnant women. With congenital syphilis cases up 700% since 2015, the timing couldn't be worse.
Imagine there's only one fire extinguisher in the building, and someone just pulled it off the wall for repairs. That's roughly what's happening with syphilis treatment in America right now.
Pfizer's Bicillin L-A, the only FDA-approved injectable penicillin used to treat syphilis in pregnant women, has been in shortage since a voluntary recall in July 2025. The cause? Floating particles found inside prefilled syringes, traced back to defective stoppers from an outside vendor. No patients were harmed, and efficacy wasn't affected. But the recall pulled 12 lots off the market, and the supply chain still hasn't recovered.
Full recovery isn't expected until late 2026 at the earliest, with some projections stretching into Q4 2027. That timeline is a problem, because the disease this drug treats is surging.
Syphilis is one of the oldest known sexually transmitted infections. Penicillin has been curing it since the 1940s. In theory, congenital syphilis (where a mother passes it to her baby during pregnancy) should be almost entirely preventable. Screen the mom, treat with a single injection, done.
But theory and reality have diverged. The U.S. reported nearly 4,000 cases of congenital syphilis in 2024, a staggering 700% increase over 2015. The rate of syphilis among women giving birth has climbed to 357.9 per 100,000 births, up 28% in just two years. American Indian and Alaska Native mothers saw a 52% increase over that same period, and Black mothers saw a 30% jump.
These aren't abstract numbers. Congenital syphilis causes stillbirths, bone deformities, and neurological damage. In 2023, roughly 279 babies died from the infection.
Now picture that crisis, and then remove the one drug proven to stop it from happening.
The core issue goes deeper than a batch of bad stoppers. Pfizer (through its subsidiary King Pharmaceuticals) is the sole FDA-approved manufacturer of benzathine penicillin G injectable suspension in the United States. There is no domestic competitor. No second source. No Plan B sitting on a shelf somewhere.

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This isn't unusual in the world of generic, injectable drugs. It's actually the norm, and that's the scary part.
The economics are straightforward: old, off-patent drugs like penicillin carry razor-thin margins. Nobody races to build a second factory for a product that barely turns a profit. So when the single factory stumbles, there's no understudy waiting in the wings. It's like an airline running one plane on its busiest route and hoping nothing breaks.
The FDA has authorized temporary importation of two foreign-made benzathine penicillin products: Extencilline (from France's Laboratoires Delbert) and Lentocilin (from Portugal's Laboratorios Atral). Same active ingredient, same dosing. These are genuine, equivalent alternatives.
But there's a catch. Extencilline stopped being available for U.S. distribution as of January 2026. That leaves Lentocilin as the only imported backup, and providers have to hunt for it through specific marketplaces and suppliers. Not every clinic in rural Mississippi or Montana can easily source a Portuguese pharmaceutical product on short notice.
For non-pregnant adults with syphilis, clinicians are pivoting to oral doxycycline: 14 days of pills for early syphilis, 28 days for late-stage. It works, but it's a fundamentally different proposition. Bicillin L-A is a single injection; you walk in, get the shot, walk out. Doxycycline requires weeks of twice-daily pill-taking, which is a tall order for patients dealing with housing instability, substance use challenges, or limited healthcare access.
Public health officials have been blunt about the stakes. Advisories from multiple states warn that the shortage "may reverse recent slowing rates of syphilis in adults and corresponding infections in babies." After years of relentless increases, congenital syphilis had finally started to plateau (growing just 2% from 2023 to 2024, compared to double-digit annual jumps in prior years). The fear is that a treatment bottleneck could erase even those modest gains.
Pfizer has implemented a medical request process that essentially rations remaining Bicillin L-A on a per-patient basis. The priority list is narrow: confirmed congenital syphilis cases and pregnant women at risk of passing the infection to their babies. Everyone else gets doxycycline or whatever their provider can find.
State health departments are running triage operations. California, Alabama, North Dakota, and Washington have all issued detailed advisories telling clinicians to check their stock, quarantine recalled lots, and reserve every remaining syringe for pregnant patients and newborns. Some states are even asking doctors to stop using injectable penicillin for other conditions (like strep throat) to conserve supply.
The CDC's position on alternatives for pregnant women is unequivocal: there are none. No proven substitute exists. Doxycycline can't be used in the second or third trimester. Erythromycin and azithromycin don't reliably cross the placenta to treat the fetus. Ceftriaxone lacks sufficient evidence. If a pregnant woman with syphilis can't get penicillin, the CDC says she should be desensitized (even if she's allergic) and given penicillin anyway. That's how irreplaceable this drug is.
This isn't just a syphilis story. It's a supply chain story, and the lesson applies to dozens of essential medicines. When an explosion at a single Chinese factory in 2016 disrupted the global supply of piperacillin-tazobactam (a common hospital antibiotic), it took months to recover. The pattern repeats: one factory, one supplier, one point of failure.
Pfizer's most recent updates indicate the next batch of adult Bicillin L-A syringes may not arrive until around October 2026, with full recovery extended to Q4 2027. The pediatric formulation (600,000 units) isn't expected until December. And those are estimates from a company that has already pushed back its recovery timeline multiple times.
In the meantime, the clock keeps ticking. Every week without adequate supply is another week where a pregnant woman might not get the one treatment that could protect her baby. We have a drug that's been saving lives for 80 years, and we can't keep it on the shelf.
Somewhere, Alexander Fleming is shaking his head.
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