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Fentanyl Citrate Injection shortage

Fentanyl Citrate Injection is currently listed in shortage by the FDA. The FDA lists 19 affected products. The reported reason: Other; Demand increase for the drug. This page was last refreshed from FDA data on Sep 29, 2026.

Current ⚠ Supply risk: Low Controlled substance Analgesia/Addiction, Pediatric 19 products 3 manufacturers 5,385 days · 14.8 yr First posted Jan 1, 2012 Updated Sep 22, 2026
Here’s the bottom line

Fentanyl citrate injection is currently in shortage, driven by higher demand and lasting over a year. Some strengths remain available from multiple makers, including Hikma and Civica, though supplies are limited and fuller recovery is not expected until late 2026.

Don’t stop or change your therapy on your own — ask your pharmacist about other manufacturers (see options) and your prescriber about a long-term plan.

Do you take this drug? See the ‘What to do’ recommendation from Dr. Brian Staiger, PharmD →
19
Affected NDCs
3
Reporting manufacturers
3/3
Reporting mfrs supplying
8/8
Affected strengths supplied
21%
NDCs unavailable
5,385
Days in shortage
358,474
Medicaid Rx (2026)
Source: FDA Drug Shortages Database API (openFDA). Last refreshed Sep 29, 2026 · today

What’s in shortage — at a glance

These figures count only the manufacturers that reported this shortage to the FDA — not every company that makes Fentanyl Citrate Injection. Other makers that haven’t reported a problem are shown in the green card below.

Availability of affected NDCs
From the FDA shortage report
19 NDCs
Available 12 Limited 3 Unavailable 4
Affected strengths still supplied
Among manufacturers reporting this shortage
8/8 strengths
Sourceable 8
FDA-reporting manufacturers with supply
Among manufacturers reporting this shortage
3/3 makers
With supply 3
✓ Other manufacturers not reporting a shortage
Still-marketed Fentanyl Citrate Injection from companies that have not filed an FDA shortage — these are not counted in the figures above. Stock can still vary by pharmacy.
Hospira, Inc. Hikma Pharmaceuticals USA Inc. Fresenius Kabi USA, LLC Civica, Inc. Phlow Corp.
See all other options & details →
Shortage timeline
  1. Sep 22, 2026
    Currently in shortage
    19 of 19 products affected.
  2. Sep 18, 2026
    FDA refreshed this shortage record
    8 products updated.
  3. Sep 15, 2026
    FDA refreshed this shortage record
    6 products updated.
  4. Dec 20, 2023
    More presentations reported
    8 more products added to the shortage.
  5. Jan 1, 2012
    First reported to the FDA
    11 products first listed.

Built from FDA posting and update dates. The end date FDA publishes is the posting/update date, not a true resolution date, so durations are approximate.

What exactly is on backorder — by manufacturer

Manufacturer: Fresenius Kabi USA, LLC 📞 888-386-1300 6 NDCS click to expand
Status NDC / product Strength Availability Related information Reason
Current Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-02) NDC 63323-0806-02 — Unavailable Next release September 2026. Check wholesalers for inventory. Other
Current Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-20) NDC 63323-0806-20 — Available Check wholesalers for inventory —
Current Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-01) NDC 63323-0806-01 — Available Check wholesalers for inventory —
Current Fentanyl Citrate, Injection, 50 ug/1 mL (NDC 63323-808-11) NDC 63323-0808-11 — Available Check wholesalers for inventory —
Current Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-50) NDC 63323-0806-50 — Available Check wholesalers for inventory —
Current Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-05) NDC 63323-0806-05 — Available Check wholesalers for inventory —
Manufacturer: Hikma Pharmaceuticals USA, Inc. 📞 800-631-2174 8 NDCS click to expand
Status NDC / product Strength Availability Related information Reason
Current Fentanyl Citrate, Injection, 50 mcg/1 mL (NDC 0641-6028-25) NDC 00641-6028-25 — Available Additional lots will be scheduled for manufacturing to meet demand. Product will be made available as it is released. —
Current Fentanyl Citrate, Injection, 50 ug/1 mL (NDC 0641-6026-05) NDC 00641-6026-05 — Unavailable Inventory available in vial presentations. Other
Current Fentanyl Citrate, Injection, 50 mcg/1 mL (NDC 0641-6247-25) NDC 00641-6247-25 — Available Additional lots will be scheduled for manufacturing to meet demand. Product will be made available as it is released. —
Current Fentanyl Citrate, Injection, 50 ug/1 mL (NDC 0641-6025-10) NDC 00641-6025-10 — Unavailable Inventory available in vial presentations. Other
Current Fentanyl Citrate, Injection, 50 ug/1 mL (NDC 0641-6024-10) NDC 00641-6024-10 — Unavailable Inventory available in vial presentations. Other
Current Fentanyl Citrate, Injection, 50 mcg/1 mL (NDC 0641-6029-25) NDC 00641-6029-25 — Available Additional lots will be scheduled for manufacturing to meet demand. Product will be made available as it is released. —
Current Fentanyl Citrate, Injection, 50 mcg/1 mL (NDC 0641-6027-25) NDC 00641-6027-25 — Available Additional lots will be scheduled for manufacturing to meet demand. Product will be made available as it is released. —
Current Fentanyl Citrate, Injection, 50 mcg/1 mL (NDC 0641-6030-01) NDC 00641-6030-01 — Available Additional lots will be scheduled for manufacturing to meet demand. Product will be made available as it is released. —
Manufacturer: Hospira, Inc., a Pfizer Company 📞 844-646-4398 5 NDCS click to expand
Status NDC / product Strength Availability Related information Reason
Current Fentanyl Citrate, Injection, 250 mcg/5 mL (50 ug/1 mL) (NDC 0409-9094-25) NDC 00409-9094-25 — Limited Availability Limited Supply Available. Next Delivery: October 2026; Estimated Recovery: December 2026 Demand increase for the drug
Current Fentanyl Citrate, Injection, 1000 mcg/20 mL (50 ug/1 mL) (NDC 0409-9094-31) NDC 00409-9094-31 — Limited Availability Limited Supply Available. Next Delivery: November 2026; Estimated Recovery: December 2026 Demand increase for the drug
Current Fentanyl Citrate, Injection, 100 mcg/2 mL (50 ug/1 mL) (NDC 0409-9094-22) NDC 00409-9094-22 — Available — —
Current Fentanyl Citrate, Injection, 2500 mcg/50 mL (50 ug/1 mL) (NDC 0409-9094-61) NDC 00409-9094-61 — Available — —
Current Fentanyl Citrate, Injection, 500 mcg/10 mL (50 ug/1 mL) (NDC 0409-9094-28) NDC 00409-9094-28 — Limited Availability Limited Supply Available. Next Delivery: September 2026; Estimated Recovery: December 2026 Demand increase for the drug

These rows are manufacturer reports to the FDA for Fentanyl Citrate Injection — they do not necessarily cover every manufacturer that makes this drug. A company appears here only if it told the FDA it has a supply problem, so other makers may still have stock. That’s the basis for the Where else can I get Fentanyl Citrate Injection? options further down this page.

Why is Fentanyl Citrate Injection in shortage?

The main reason fentanyl citrate injection is on the FDA shortage list is that more people need it than the supply can keep up with right now — what the FDA calls a "demand increase." On top of that, a few specific package sizes also have other, unspecified issues that the manufacturers haven't detailed publicly.

Here's what's happening with each company reported here:

  • Fresenius Kabi has most of their 0.05 mg/1 mL vials available, but one packaging version is currently unavailable, with the next release expected September 2026.
  • Hospira (Pfizer) has three sizes in limited supply due to higher-than-usual demand: the 500 mcg/10 mL (next delivery September 2026), the 250 mcg/5 mL (next delivery October 2026), and the 1000 mcg/20 mL (next delivery November 2026) — with full recovery estimated by December 2026 for all three. Their 100 mcg/2 mL and 2500 mcg/50 mL sizes are currently available.
  • Hikma has several vial presentations available and is scheduling extra manufacturing runs to keep up with demand, though a few of their ampule/syringe presentations are currently unavailable — they note that vial versions remain in stock.
FDA reason code(s): Other; Demand increase for the drug

Based on the manufacturer-reported reason(s) and notes on file with the FDA for Fentanyl Citrate Injection, summarized in plain English by HelloPharmacist. A drug can be short for more than one reason, and the FDA updates these as manufacturers report changes.

What should I do if I take Fentanyl Citrate Injection?

Fentanyl Citrate Injection is currently on the FDA shortage list. This is a medicine given in a hospital or clinic setting, so your care team manages the actual supply — but here is what the national data shows so you understand the situation.

Every strength on this record still has an available source, so none of the eight listed strengths is completely out of supply right now. Some strengths — including 500 mcg/10 mL, 1000 mcg/20 mL, and 250 mcg/5 mL — are marked as limited, with more deliveries expected between September and December 2026. Other strengths, such as the 50 mcg/1 mL and 50 ug/1 mL vials, are listed as available. All three manufacturers on this record are still reporting supply.

The reported reasons are higher demand and "other" manufacturing factors. This shortage has lasted over a year, but because three makers are still supplying it, the overall supply risk is rated low.

What you can do:

  • Do not stop, skip, or change any dose on your own.
  • Ask your pharmacy or care team to order your strength — they can check wholesalers and all three manufacturers.
  • If your usual source is limited, the same medicine may be available from another maker (Hospira, Hikma, Fresenius Kabi, Civica, or Phlow), though it may not be in local stock.
  • Ask your prescriber or pharmacist about options if a specific presentation cannot be found.

Manufacturer contact numbers are listed on this page for reference; pharmacies usually handle those calls. This reflects national, manufacturer-reported data and may not match your local stock.

See “Where else can I get Fentanyl Citrate Injection?” below ↓ The same medicine from manufacturers not reporting a shortage, alternative dosage forms, and therapeutic equivalents with pricing.
If you are a patient:
  • Don’t stop or change the medication on your own — talk to your prescriber first.
  • If this is part of an ongoing or essential regimen (for example HIV treatment or prevention, seizure, heart, transplant, diabetes or mental-health medicines), do not skip or ration doses — contact your pharmacist or prescriber right away to arrange continued supply before you run out.
  • Ask your pharmacy to check other manufacturers, strengths, package sizes, and nearby stores.
  • Ask your prescriber whether a different strength, formulation, or the brand/generic version is appropriate.
  • This is a controlled substance. Transfers between pharmacies and switching strengths have extra federal/state rules — ask the pharmacy before you assume a transfer is possible.
Keep reading
Our full Fentanyl guide

Uses, dosing, side effects, prices, and the complete FDA label — written in plain English and pharmacist-reviewed.

Read the Fentanyl guide →

Where else can I get Fentanyl Citrate Injection?

FDA shortages are manufacturer-reported — a company only shows up on the shortage list if it told the FDA it has a supply problem, so not every maker of Fentanyl Citrate Injection is necessarily short. Below we pull together the other still-marketed options that are not reported in shortage: the same medicine from manufacturers that haven’t reported a problem, and alternative dosage forms. These may still be out of stock at your pharmacy, and only your prescriber or pharmacist can decide what’s right for you.

Same medicine, other manufacturers (not reported short)

Same active ingredient, dosage form & route as the shortage (matched on the FDB HICL ingredient code), from makers that have not filed a shortage with the FDA:

ProductStrengthForm / routeManufacturerNDC
Fentanyl Citrate FENTANYL CITRATE 50 ug/mL Injection, Solution · Intramuscular, Intravenous Hospira, Inc. 00409-9093-11
Fentanyl Citrate FENTANYL CITRATE 50 ug/mL Injection · Intramuscular, Intravenous Hikma Pharmaceuticals USA Inc. 00641-6028-10
Fentanyl Citrate FENTANYL CITRATE 100 ug/2mL Injection, Solution · Intramuscular, Intravenous Fresenius Kabi USA, LLC 63323-0810-20
Fentanyl Citrate FENTANYL CITRATE 50 ug/mL Injection · Intramuscular, Intravenous Civica, Inc. 72572-0170-25
Fentanyl Citrate FENTANYL CITRATE 50 ug/mL Injection · Intramuscular, Intravenous Phlow Corp. 81565-0205-02
Therapeutic equivalents & pricing 3 productsclick to expand

Orange Book–rated equivalents of the affected strengths, with the latest NADAC price (a federal retail-acquisition benchmark, not your copay) and an evidence-based availability label. Cheapest first.

ProductManufacturerPackageNADAC $/unitAB ratingAvailability
Fentanyl Citrate .05 mg/mLNDC 63323-0806-02 Fresenius 25 vials $1.786 AP Availability likely
Fentanyl Citrate .05 mg/mLNDC 63323-0806-20 Fresenius 25 vials — AP FDA listed
Fentanyl Citrate .05 mg/mLNDC 63323-0806-01 Fresenius 25 vials — AP FDA listed

Equivalents share the same ingredient, strength, dosage form and route; an AB rating means the FDA considers them substitutable. NADAC is a national retail-pharmacy acquisition benchmark from CMS — not what you pay. Availability is inferred from recent pricing, not a stock check.

Other drugs in the same treatment class

These are different medicines — not other versions of Fentanyl Citrate Injection — that fall in the same broad treatment class (opioid analgesic, anesthetic adjunct agents) . They are not automatic substitutes: they can differ in how they work, dosing, effectiveness, side effects and what they’re approved to treat. Do not switch on your own. This list is for information only — ask your prescriber or pharmacist whether any of them is appropriate for you.

Identity & classification

GCN Seq No 041385
GCN 32807
HICL code 025386
Ingredient (HICL) Fentanyl Citrate/Pf
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H3
Therapeutic class — intermediate (HIC2) Analgesics
HIC3 code H3H
Therapeutic class — specific (HIC3) Opioid Analgesic, Anesthetic Adjunct Agents
AHFS code 28:08.08.00
AHFS class Opioid Agonists (28:08)
FDB label name FENTANYL 100 MCG/2 ML VIAL
FDB brand name Fentanyl Citrate
Legend status F — Federal legend — prescription drug or device
GPI-1465100025102007
GPI classfentaNYL Citrate (PF)
DEA scheduleCII
Where does this data come from?
Identity codes come from First Databank (FDB) (HICL ingredient, HIC1–3 therapeutic-class hierarchy, GCN, AHFS class, legend status) and Medi-Span GPI, mapped from a representative affected NDC. Licensed reference data — for identification only.

Other analgesia/addiction, pediatric shortages

Fentanyl Citrate Injection shortage FAQs

Is Fentanyl Citrate Injection in shortage?
Yes — the FDA currently lists Fentanyl Citrate Injection in shortage (status: “Current”, first reported Jan 1, 2012). 19 of 19 products are affected. This is national, manufacturer-reported data, so your pharmacy may still have stock.
Why is Fentanyl Citrate Injection in shortage?
The manufacturer-reported reason on file with the FDA: Other; Demand increase for the drug. Limited Supply Available. Next Delivery: September 2026; Estimated Recovery: December 2026.
Which products are affected?
Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-02) (NDC 63323-0806-02); Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-20) (NDC 63323-0806-20); Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-01) (NDC 63323-0806-01). The full per-NDC list (availability, manufacturer and status) is in the table above — each NDC links to its own page.
When will Fentanyl Citrate Injection be available again?
The manufacturer reports: Limited Supply Available. Next Delivery: September 2026; Estimated Recovery: December 2026. The FDA does not publish a single guaranteed restock date — confirm with your pharmacy.
Can I still get Fentanyl Citrate somewhere?
Other manufacturers (Hospira, Inc., Hikma Pharmaceuticals USA Inc., Fresenius Kabi USA, LLC and others) still market it and have not reported a shortage. See “Where else can I get Fentanyl Citrate Injection?” above — stock still varies by pharmacy.
What should I do if I take Fentanyl Citrate Injection?
Don’t stop or change it on your own. Ask your pharmacist whether they can order it from another manufacturer or a different strength/package size, and ask your prescriber about a long-term plan before your supply runs out. Because this is a controlled substance, transfers and substitutions have extra federal/state rules — ask the pharmacy first.

Still have a question about the Fentanyl Citrate Injection shortage?

Ask a pharmacist about this shortage →
How to read the Supply-Risk rating
Low (1–2)Multiple manufacturers still supplying and most strengths or pack sizes sourceable.
Medium (3)Some constraint — fewer suppliers or a notable share of NDCs unavailable.
High (4–5)Down to a single source, most strengths or pack sizes unsourceable, or a long-running outage.
Where does this data come from?
Shortage records come from the FDA Drug Shortages Database API via openFDA (/drug/shortages) — drug, manufacturer & contact, NDC/product, status, availability, reason, therapeutic category and posting/update dates. Current / To Be Discontinued = active; Resolved is kept for history. The Supply-Risk rating is assessed per active ingredient and adds the FDA NDC Directory (still-marketed manufacturers by ingredient & form); same-medicine and equivalent products use First Databank classification + CMS NADAC pricing; Medicaid use + most-affected states come from CMS Medicaid State Drug Utilization Data. Reference only — confirm current status with the manufacturer or FDA before acting on it.
Data structure & sourcing designed and verified by Dr. Brian Staiger, PharmD.
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