The penicillin G benzathine shortage

FDA added penicillin G benzathine injection to its drug shortage list on April 26, 2023. It is still there. When the agency revised the entry on Oct. 21, 2026, the smallest prefilled syringe was listed as unavailable, with a next delivery of October 2027 and an estimated recovery of December 2027. By GxRadar's count, the shortage had lasted 1,287 days as of Nov. 3, 2026.

Penicillin G benzathine is a long-acting form of penicillin given by intramuscular injection, and it is central to the US response to syphilis. The CDC's treatment guidelines state that "parenteral penicillin G is the only therapy with documented efficacy for syphilis during pregnancy," according to the guidelines' syphilis section³.

Its shortage began in the middle of a long rise in congenital syphilis, the infection passed to a baby during pregnancy, which CDC says increased for a 12th straight year in 2024. This history follows the shortage through FDA and CDC documents: why one product had no backup, how FDA twice turned to temporary importation, and where supply stands in late 2026. It does not cover treatment choices, which belong with clinicians working from CDC's guidelines.

One approved product, and rising demand

There was no second source to fall back on. In a December 2024 presentation to clinicians², FDA said only one FDA-approved penicillin G benzathine injectable suspension was marketed in the United States, and that the shortage began "due to demand outpacing supply," driven by "increased rates of syphilis." When FDA asked other countries' regulators for help, the slides said, most of them named the same company as their own source. Our piece on why some drugs have only one maker explains how markets end up this thin.

FDA's database lists three prefilled syringe sizes: 600,000 units in 1 mL, 1.2 million units in 2 mL and 2.4 million units in 4 mL. The sizes have had different fortunes. As of Nov. 12, 2024, FDA's slides showed the 600,000-unit syringe unavailable, the 1.2 million-unit syringe available and the 2.4 million-unit syringe in limited supply.

Demand had been climbing for years. CDC's provisional surveillance report for 2024 counted nearly 4,000 congenital syphilis cases and said the total was "nearly 700% higher" than a decade earlier, according to the agency's 2024 STI surveillance page⁴.

Source: CDC, Sexually Transmitted Infections Surveillance, 2024 (Provisional)⁴. Percent changes calculated by GxRadar. CDC says 2024 counts will likely rise before the data are final, because congenital cases can be diagnosed and reported years after birth.

Broader syphilis counts have turned. CDC said primary and secondary syphilis cases fell for a second year in 2024, down 22 percent from 2023. Congenital cases did not follow.

A timeline from FDA and CDC records

How the imports worked

Temporary importation lets FDA allow in a foreign-approved product it has not approved, by choosing not to enforce the import bar for a time. FDA's shortage FAQ¹³ says the agency looks for an FDA-registered foreign manufacturer "willing and able to redirect foreign-approved product into the U.S. market" and evaluates the formulation and the plant. Its slides called the step a "last resort to meet critical patient need" and said FDA must "confirm import will not cause shortage in other countries." Our explainer on temporary importation covers the mechanism in other shortages.

The first import arrived as powder with a separate diluent rather than a ready-made suspension, according to the November 2023 letter⁶, which said it was "marketed in France and manufactured in Italy" and "not FDA-approved." The CDC's January 2024 letter⁵ said FDA had determined it "to be equivalent" to the US product, and warned that "the preparation and administration" and the contraindications "differ." The CDC also acknowledged that clinicians would have "questions related to pricing, distribution, and availability."

The Portuguese product came with its own list of differences. The June 2024 letter⁸ said its barcode might not scan on US systems and that its maker did not meet the Drug Supply Chain Security Act requirements for electronic tracing. The June 2026 renewal⁹ opened its list of key differences with the absence of a boxed warning on the imported label, telling clinicians to refer to the US product's warning.

In the Oct. 21, 2026 version of FDA's entry, the Portuguese product, last reverified Sept. 15, was the only presentation marked "Available."

A recall during the shortage

In July 2025, a Class II recall removed 19,279 vials of the 2.4 million unit product, with the reason recorded as "CGMP Deviations; particulates identified during visual inspection," according to openFDA's enforcement records¹¹. The record was still listed as ongoing in late 2026. Class II is FDA's middle tier, for a product that "may cause temporary or medically reversible adverse health consequences," according to FDA's recall definitions¹⁴. GxRadar's recall data and our guide to checking a recall explain the categories.

Where supply stands

Supply estimates slipped through 2026. The January 2026 availability letter¹⁰ posted with the shortage entry said the prefilled syringes remained "on allocation at the wholesaler level." For the two larger sizes, it gave a next delivery of July 2026 and projected recovery in the fourth quarter of 2026. It also said direct requests outside normal wholesale channels would be limited to patients with confirmed congenital syphilis or at risk of it.

By the Oct. 21, 2026 revision, the two larger syringes were in limited supply with a next delivery in November 2026 and recovery estimated for September 2027. The 600,000-unit syringe was unavailable until October 2027, with recovery in December 2027. The reason field read "Other," and the related information said "Shortage per Manufacturer: Manufacturing Delay." Those estimates come from the manufacturer and change often, as our guide to the database explains.

Penicillin G benzathine is one of seven anti-infective drugs on FDA's current list, which GxRadar tracks on its shortage page using openFDA data¹². For the wider pattern, see why antibiotics keep running short. For anyone whose own treatment is affected, the questions to raise with a clinic, prescriber or pharmacist are collected in what to ask during a shortage.

Two markers are already on the calendar. CDC says it expects to finalize its 2024 STI figures in 2026, and FDA's database puts full recovery of the approved product at December 2027.