Lidocaine is on backorder primarily because only two companies manufacture injectable lidocaine within the United States, and both have experienced prolonged manufacturing delays. This bottleneck, combined with rising demand and a supply chain that depends entirely on foreign sources for the drug’s active ingredient, has kept multiple lidocaine formulations listed as unavailable on the FDA’s drug shortage database since early 2024, with some shortages tracing back over a decade.
Which Formulations Are Affected
The FDA currently lists several injectable lidocaine products as unavailable. These include the 1% concentration in 20 mL vials, the 1% pre-filled syringes (which have been permanently discontinued), and the 2% concentration with epinephrine. All were last updated in February 2026, and the reasons listed are either manufacturing delays or outright discontinuation.
The shortage hits hardest for preservative-free formulations, which are required for spinal and epidural procedures where preservatives could cause nerve damage. When those run out, clinicians face difficult decisions about whether to use preservative-containing alternatives at lower doses or delay procedures entirely. Formulations with epinephrine, commonly used in dermatology and dental work, have also been in short supply since the shortage was first posted in 2012.
Too Few Manufacturers, Too Little Flexibility
The core problem is concentration of production. Pfizer and Fresenius Kabi are the only two companies manufacturing injectable lidocaine in the U.S. When either one hits a snag, there’s almost no slack in the system. Major players like Teva and Hikma also produce lidocaine globally, but intermittent production interruptions across the industry have made the supply unreliable for years.
Making matters worse, while about 39% of lidocaine products sold in the U.S. are manufactured domestically, none of the active pharmaceutical ingredient comes from domestic suppliers registered with the FDA. Every milligram of the raw material is sourced from overseas. That means even U.S.-based production depends on a global supply chain vulnerable to shipping delays, trade restrictions, and foreign regulatory issues.
Manufacturing Quality Is the Biggest Bottleneck
The single largest cause of routine drug shortages in the U.S. is failure to maintain manufacturing quality, according to an FDA task force analysis. For injectable drugs like lidocaine, the standards are especially strict. Even minor quality control infractions can trigger temporary production line shutdowns, and getting a facility back online after a regulatory hold takes months, not weeks. Manufacturers can’t simply flip a switch to ramp up production when they fall behind.
This isn’t a new phenomenon. The FDA first posted a lidocaine shortage in February 2012, citing increased demand, manufacturing delays, and discontinuation of specific formulations. The current shortage is a continuation of structural weaknesses that have never been fully resolved.
Demand Has Outpaced Supply for Years
On the demand side, several forces have pushed lidocaine use higher. An aging population needs more procedures. Advances in outpatient surgery, dermatology, and pain management have expanded the number of settings where lidocaine is routine. After the pandemic, a wave of patients came in for procedures they had deferred during lockdowns, creating a sustained bump in demand that manufacturers weren’t prepared for.
The pandemic also created direct competition for manufacturing capacity. Pharmaceutical companies shifted resources toward COVID-19 vaccine production, and lidocaine, a low-margin generic drug, was not a priority. Companies tend to allocate production capacity toward higher-margin medications, and lidocaine’s complex manufacturing requirements relative to its slim profits make it an unattractive product to scale up. This economic reality means there’s little incentive for new manufacturers to enter the market, even when shortages persist.
Supply Chain Pressures Beyond the Factory
Global logistics have compounded the problem. Shipping container costs quadrupled from their 2020 levels, and port congestion delayed deliveries of raw materials and finished products alike. For a drug that already depends on overseas sourcing for its active ingredient, these transportation disruptions added weeks or months to already-strained timelines.
Regulatory restrictions on importing lidocaine have also played a role. Even when lidocaine is produced in the U.S. and exported, restrictions can prevent it from being re-imported to address domestic shortages. The FDA has the authority to exercise temporary enforcement discretion and allow imports from foreign manufacturers, but it has reserved this tool for rare, critical situations and has not publicly listed lidocaine among the drugs receiving that exception.
How Hospitals and Clinics Are Adapting
With supply uncertain, healthcare providers have adopted workarounds. One common strategy in dermatology is diluting lidocaine 1% with saline in a 1:1 ratio to create a 0.5% solution, effectively doubling the number of procedures a single vial can cover. Studies in Mohs surgery have found that 0.5% lidocaine with epinephrine provides equivalent pain control to the standard 1% concentration, making this a practical option rather than a compromise.
For procedures that don’t involve the spine or epidural space, clinicians can use preservative-containing lidocaine for joint, tendon, and ligament injections without significant additional risk. Some practices have also turned to alternative local anesthetics when available, though these carry their own supply constraints and different dosing profiles.
Smaller, more agile manufacturers have stepped into the gap. Sintetica US, for example, capitalized on the February 2024 shortage by supplying alternative vial sizes and capturing premium pricing for on-time deliveries. But these smaller suppliers don’t yet have the volume to replace what the major manufacturers can’t provide, and some of the larger producers have projected that key injectable formulations won’t be fully resupplied until 2026.
What the FDA Is Doing
The FDA’s drug shortage staff works across all manufacturers of a drug to coordinate production and demand information. Their toolkit includes expediting regulatory reviews and inspections, allowing manufacturers to continue producing medically necessary products while fixing quality issues, extending expiration dates on existing stock, and approving new manufacturing sites or raw material sources on a faster timeline. In some cases, the agency permits additional safety controls like extra testing or third-party oversight so that a factory can keep running during remediation rather than shutting down entirely.
These measures help at the margins, but they don’t address the structural issue: too few manufacturers making a low-profit drug with 100% foreign-sourced raw materials. Until that changes, lidocaine shortages are likely to recur whenever any single manufacturer hits a disruption.