The FDA Drug Shortages database lists 342 injectable presentations under the Anesthesia therapeutic category (run date June 10, 2026) — more than any other therapeutic category on the active list. Of those 342 records, 99 — roughly 29 percent — are not fully available right now: 80 are listed as Unavailable and 19 as Limited Availability. Eleven of the 14 distinct active ingredients in the category have at least one presentation that hospitals and ambulatory surgery centers cannot reliably buy today. And these are not fresh disruptions: the median currently-unavailable record was first posted 3,005 days ago, and the oldest has been on the list since February 2012 — roughly 14.5 years.
This is a narrow read of one therapeutic segment of the FDA Drug Shortages database, written for perioperative pharmacy, surgical-suite operations, 340B and buy-and-bill teams, and access planners who model surgical-throughput risk. Every figure is computed from the public FDA Drug Shortages list, run date June 10, 2026. For the database-wide shortage picture, see the companion FDA drug shortage analysis; for the oncology injectable sub-segment, see cisplatin and carboplatin. This article stays on anesthesia.
Methodology, in one paragraph
The source is the FDA Drug Shortages dataset (openFDA /drug/shortages endpoint), run date June 10, 2026, 1,680 records total. A "record" is a single package-level NDC presentation (one company, one strength, one package) on the shortage list — not one drug. I filtered to records tagged therapeutic_category = Anesthesia, all of which are injectable or concentrate dosage forms. "Not fully available" combines the Unavailable and Limited Availability availability values. "Currently problematic" further requires status = Current. Durations are computed from each record's initial_posting_date through June 14, 2026. Active-ingredient names follow openFDA's substance_name field; the 14 distinct names include salt-form variants of the same base drug (for example, lidocaine hydrochloride and its anhydrous form), counted as the database records them.
The anesthesia segment at a glance
Anesthesia injectables are the single largest therapeutic category on the FDA shortage list. Of the 1,146 records with status = Current across all categories, 329 — about 29 percent — are anesthesia. The next categories (psychiatry, pediatrics, cardiovascular) sit lower. All 342 anesthesia records are injectable or concentrate products; there are no oral solids in the segment.
The 342 records cover 14 distinct active-ingredient names across four functional perioperative classes:
- Local anesthetics — bupivacaine, ropivacaine, lidocaine (the workhorses of regional anesthesia, nerve blocks, spinal and epidural)
- Neuromuscular blocking agents — rocuronium and vecuronium (intubation and surgical relaxation)
- Perioperative sedatives — dexmedetomidine, midazolam, etomidate, ketamine (induction, procedural and ICU sedation)
- Resuscitation / ACLS drugs — atropine and epinephrine (bradycardia, anaphylaxis, cardiac arrest on the OR table)
Notably, propofol is not on this list — the prototypical induction agent has zero records in the current dataset and is considered available. The chronic problem is concentrated one tier out: the long-acting local anesthetics and the sedatives that regional-block and MAC (monitored anesthesia care) practice depend on.
What is unavailable today
Ninety-nine of the 342 anesthesia presentations are not fully available. The concentration is narrow and deep — six molecules account for the bulk of the problem:
| Active ingredient | Presentations on list | Not fully available | Share unavailable/limited |
|---|---|---|---|
| Bupivacaine HCl | 69 | 23 | 33% |
| Ropivacaine HCl | 46 | 15 | 33% |
| Lidocaine HCl | 40 | 11 | 28% |
| Midazolam HCl | 26 | 11 | 42% |
| Dexmedetomidine HCl | 57 | 9 | 16% |
| Atropine sulfate | 18 | 8 | 44% |
Epinephrine (both the bitartrate and base forms, 22 presentations combined) adds another 8 unavailable or limited records, etomidate adds 4, and rocuronium adds 4. Eleven of the 14 active-ingredient names in the category have at least one presentation hospitals cannot buy in full. The three with no current availability gap — vecuronium, the standalone midazolam entries, and the single ketamine record marked for discontinuation — are either near-absent from the list or slated to leave it.
The hardest-hit molecule by proportion is atropine (44 percent of its presentations not fully available), followed by midazolam (42 percent). These are not exotic agents — atropine is on the WHO Essential Medicines List, and midazolam is one of the highest-volume preoperative sedatives in U.S. practice.
Duration: these are structural, not transient
The most striking feature of the anesthesia shortage set is how old it is. Every one of the 99 currently-unavailable records was first posted more than a year ago; none is a 2026 flash event.
- Median age of a currently-unavailable record: 3,005 days (about 8.2 years)
- Mean age: 3,209 days (about 8.8 years)
- Records 10 or more years old: 23 of the 99
- Oldest active record: 5,278 days (about 14.5 years), first posted in early 2012
Bucketed, 68 of the 99 problematic records were first posted 5–10 years ago, 23 are more than 10 years old, and only 8 fall in the 3–5-year window. The 2012 and 2018 posting cohorts dominate — many of these presentations have been reverified on the list, year after year, without ever resolving. This matches the long-recognized pattern for cheap, old, sterile-injected generics: low margin, concentrated manufacturing, and recurring quality or demand shocks that never quite clear.
Supply is concentrated in two companies
The 99 currently-problematic presentations trace to a small set of sterile-injectable manufacturers, and two of them dominate:
- Fresenius Kabi USA — 29 of 99 problematic presentations
- Hospira (Pfizer) — 27 of 99
- Eugia US — 12
- Accord Healthcare — 7
Fresenius Kabi and Hospira/Pfizer together account for 56 of the 99 unavailable or limited anesthesia presentations — roughly 57 percent. When either of those two lines hits a delay, the category feels it across the country, because for many of these old molecules there are only two or three commercial suppliers and no idle capacity to absorb the gap. The FDA's own Extended Use Date list — a stopgap that lets hospitals use certain lots past their labeled expiry to bridge shortages — currently includes bupivacaine spinal injection and dextrose injection, a direct signal that regulators are treating some of these as continuity emergencies rather than routine supply hiccups.
Why these shortages do not clear
The shortage_reason field is sparsely populated (241 of 342 records carry no reason), but where FDA attributes a cause, the distribution is telling:
- Demand increase — 34 records
- Discontinuation of manufacture — 14 records
- Delay in shipping — 10 records
- GMP / manufacturing compliance — 3 records
- Other — 39 records
"Demand increase" and "discontinuation" together describe the structural problem more honestly than any quality-recall narrative: these are low-priced generics where manufacturers have consolidated, exited unprofitable strengths, or simply cannot scale sterile capacity to meet surgical-volume growth. Anesthesiologists report the downstream effects directly — an American Society of Anesthesiologists survey found more than 98 percent of respondents saw regular shortages and over 95 percent judged them impactful on patient care, and the academic literature links propofol substitution to a doubling of postoperative nausea (from roughly 5 percent to 11 percent) when the first-line agent is unavailable.
What this means for perioperative, pharmacy, and access teams
- Surgical-throughput risk is a supply problem, not just a staffing problem. The 2026 ambulatory-surgery narrative leans heavily on anesthesia workforce shortages, but the drug-supply layer is independently binding: a facility cannot run a block schedule for regional anesthesia if bupivacaine and ropivacaine are on allocation.
- The shortage directly undercuts a 2025–2027 Medicare payment incentive. The NOPAIN Act (Section 4135 of the Consolidated Appropriations Act, 2023) requires CMS to pay separately — outside the bundled surgical fee — for qualifying non-opioid post-surgical analgesics and regional-anesthesia agents in hospital outpatient departments and ambulatory surgery centers, effective January 1, 2025 through December 31, 2027, with 18 product codes eligible as of January 2026. The agents the law is meant to expand access to are precisely the long-acting local anesthetics (bupivacaine, ropivacaine) that dominate the unavailable list — so a payer policy designed to pull perioperative care away from opioids lands on a supply base that cannot reliably fill the demand it creates.
- Plan formulary substitutions around the six problem molecules. Bupivacaine, ropivacaine, lidocaine, midazolam, dexmedetomidine, and atropine are where the unavailability concentrates. Tiered therapeutic alternatives (mepivacaine or chloroprocaine for regional blocks; dexmedetomidine-versus-propofol trade-offs for sedation; glycopyrrolate for atropine) should be pre-vetted before a stockout forces a same-day substitution. The regional-anesthesia societies flag this as a patient-safety issue, not just a logistics issue, because local-anesthetic nerve blocks are the main opioid-sparing lever in modern perioperative care.
- Single-source-risk modeling should weight Fresenius Kabi and Hospira/Pfizer exposure. Because 57 percent of the currently-unavailable presentations sit with two companies, a contract or allocation strategy that depends on either of them as sole supplier for a local anesthetic or a perioperative sedative is the highest-risk configuration in the category.
- Do not expect near-term resolution from new ANDAs. These are old, off-patent molecules — the bottleneck is sterile manufacturing capacity and commercial margin, not patent or exclusivity, so generic entry is not the relief valve it is elsewhere. The Extended Use Date program and allocation management are the realistic bridges for the next 12–24 months.
- For buy-and-bill and 340B teams, expect continued gray-market and allocation pressure on exactly these low-acquisition-cost agents, where the gap between list economics and the operational cost of a stockout is widest.
Sources
- US FDA, Drug Shortages database (openFDA
/drug/shortages), run date June 10, 2026 — 1,680 records; anesthesia therapeutic-category aggregates computed by PharmaDossier from the public extract. https://www.accessdata.fda.gov/scripts/cder/drugshortages/ - US FDA, "Search List of Extended Use Dates to Assist with Drug Shortages" (includes bupivacaine spinal injection and dextrose injection extended-use entries). https://www.fda.gov/drugs/drug-shortages/search-list-extended-use-dates-assist-drug-shortages
- De Oliveira GS Jr, Theilken LS, McCarthy RJ, "Shortage of perioperative drugs: implications for anesthesia practice and patient safety," Anesthesia & Analgesia, 2011;113:1429–1435. https://pmc.ncbi.nlm.nih.gov/articles/PMC4031712/
- American Society of Anesthesiologists physician drug-shortage survey; "Drug Shortages in Anesthesia" review of >98% shortage prevalence and >95% patient-care impact. https://philadelphiaanesthesiaservices.com/drug-shortages-in-anesthesia
- "US Propofol Drug Shortages: A Review of the Problem and Stakeholder Analysis" (sterile-injectable shortage epidemiology; ~80% of U.S. drug shortages involve sterile injectables). https://pmc.ncbi.nlm.nih.gov/articles/PMC4031712/
- "Anesthesia Drug Shortages: Crisis Management in the Operating Room" (most-affected agents: propofol, vecuronium, rocuronium, bupivacaine, lidocaine; demand, manufacturing, and raw-material causes). https://globalrph.com/2025/12/anesthesia-drug-shortages-crisis-management-in-the-operating-room
- American Society of Anesthesiologists, "Statement on Neuraxial Medication Shortage and Alternatives" (lidocaine and bupivacaine shortages persisting for over 10 years; obstetric neuraxial impact). https://www.asahq.org/standards-and-practice-parameters/statement-on-neuraxial-medication-shortage-and-alternatives
- American Society of Regional Anesthesia and Pain Medicine (ASRA), "The Crisis of Drug Shortages in Regional Anesthesia and Analgesia" (local anesthetics as the opioid-sparing backbone; bupivacaine/ropivacaine/lidocaine). https://asra.com/news-publications/asra-newsletter/newsletter-item/asra-news/2018/07/20/the-crisis-of-drug-shortages-in-regional-anesthesia-and-analgesia
- ASC Focus / ASCA, "2026 Rulemaking Increases Separate Reimbursement for Non-Opioid Alternatives" (NOPAIN Act; Section 4135, Consolidated Appropriations Act 2023; separate Medicare Part B payment for non-opioid post-surgical analgesics in HOPD/ASC, effective Jan 1, 2025 – Dec 31, 2027; 18 eligible codes as of Jan 2026). https://www.ascfocus.org/202602-2026-rulemaking-increases-separate-reimbursement-for-non-opioid-alternatives
- US FDA, Drug Shortage Prevention Act of 2023 and manufacturer notification framework. https://www.fda.gov/drugs/drug-shortages
