Quick answers
- What is Fentanyl used for?
- The FDA-approved label (Fentanyl Citrate, Hospira, Inc., August 24, 2026) says: “Fentanyl Citrate Injection is indicated for: • analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises. • use as an opioid analgesic supplement in general or regional anesthesia. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Fentanyl have a boxed warning?
- Yes. The FDA label for Fentanyl Citrate has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Fentanyl?
- The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 21, 2026). Ask your pharmacist about alternatives.
- Has Fentanyl been recalled?
- FDA enforcement reports list 7 recalls of products of this medicine; the newest started January 31, 2025 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Fentanyl?
- 10 companies list prescription products of Fentanyl in the FDA NDC Directory, including Aveva Drug Delivery Systems Inc., Ingenus Pharmaceuticals, LLC and Mylan Pharmaceuticals Inc..
What Fentanyl is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Fentanyl Citrate Injection is indicated for: • analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises. • use as an opioid analgesic supplement in general or regional anesthesia. …
— FDA label: Fentanyl Citrate, Hospira, Inc., effective August 24, 2026. Read the full label on DailyMed →
The FDA has 11 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
11 of 11 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Patch, extended release · Patch · Injection · Injection, solution |
|---|---|
| Route | Transdermal · Intravenous · Intramuscular |
| Prescription products | 53 in the FDA NDC Directory |
| Brand names | Fentanyl System |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| fentanyl 100 ug patch | Generic | $19.62 per patch |
| fentanyl 100 ug/h patch | Generic | $19.62 per patch |
| fentanyl 100 ug/h patch, extended release | Generic | $19.62 per patch |
| fentanyl 12 ug/h patch | Generic | $9.37 per patch |
| fentanyl 12 ug/h patch, extended release | Generic | $9.37 per patch |
| fentanyl 12.5 ug patch | Generic | $9.37 per patch |
| fentanyl 12.5 ug/h patch, extended release | Generic | $9.37 per patch |
| fentanyl 25 ug patch | Generic | $6.07 per patch |
| fentanyl 25 ug/h patch | Generic | $6.07 per patch |
| fentanyl 25 ug/h patch, extended release | Generic | $6.07 per patch |
| fentanyl 37.5 ug/h patch | Generic | $36.19 per patch |
| fentanyl 37.5 ug/h patch, extended release | Generic | $36.19 per patch |
| fentanyl 50 ug patch | Generic | $9.07 per patch |
| fentanyl 50 ug/h patch | Generic | $9.07 per patch |
| fentanyl 50 ug/h patch, extended release | Generic | $9.07 per patch |
| fentanyl 62.5 ug/h patch | Generic | $57.69 per patch |
| fentanyl 62.5 ug/h patch, extended release | Generic | $57.69 per patch |
| fentanyl 75 ug patch | Generic | $15.80 per patch |
| fentanyl 75 ug/h patch | Generic | $15.80 per patch |
| fentanyl 75 ug/h patch, extended release | Generic | $15.80 per patch |
| fentanyl citrate 0.05 mg/mL injection, solution | Generic | $1.76 per mL |
| fentanyl citrate 50 ug/mL injection | Generic | $1.76 per mL |
| fentanyl citrate 50 ug/mL injection, solution | Generic | $1.76 per mL |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Aveva Drug Delivery Systems Inc.8 products
- Ingenus Pharmaceuticals, LLC8 products
- Mylan Pharmaceuticals Inc.8 products
- Hikma Pharmaceuticals USA Inc.8 products
- SpecGx LLC7 products
- Alvogen5 products
- Fresenius Kabi USA, LLC3 products
- Civica, Inc.3 products
- Hospira, Inc.2 products
- Phlow Corp.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA019101 FENTANYL CITRATE | Hikma | July 11, 1984 | 34, latest December 22, 2025 2025: Labeling · 2025: Labeling · 2023: Labeling |
| NDA019115 FENTANYL CITRATE | Hospira | January 12, 1985 | 19, latest December 22, 2025 2025: Labeling · 2023: Labeling · 2019: Labeling |
Generic approvals (6)
- ANDA076258Mylan Technologies · January 28, 2005
- ANDA077449Difgen Pharms · October 20, 2008
- ANDA077154Specgx LLC · February 9, 2011
- ANDA202097Kindeva · November 4, 2016
- ANDA210762Fresenius Kabi USA · May 3, 2019
- ANDA212086Fresenius Kabi USA · September 1, 2020
Shortage status
Current shortage · updated October 21, 2026 · first posted January 1, 2012
| Product | Fentanyl Citrate, Injection, 250 mcg/5 mL (50 ug/1 mL) (NDC 0409-9094-25) |
|---|---|
| Availability | Limited Availability |
| Reason given | Demand increase for the drug |
| Company | Hospira, Inc., a Pfizer Company |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
January 31, 2025 · Class I · Ongoing · D-0245-2025
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058, Manufactured by: Kindeva Drug Delivery L/P, Northridge, CA — Alvogen, Inc
-
July 20, 2020 · Class II · Terminated · D-1446-2020
Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop Vials, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA NDC 0409-9094-12 — Pfizer Inc.
-
April 19, 2019 · Class I · Terminated · D-1277-2019
Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing 50 mcg/h.
FENTANYL Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058; Manufactured by: 3M Drug Delivery Systems, St. Paul, MN 55107, NDC 47781-423-47. — Alvogen, Inc
-
May 13, 2015 · Class III · Terminated · D-1139-2015
Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, For IV or IM Use Preservative Free, 25 X 5 mL Single Dose Vials per Carton, Manufactured by: West-Ward, Eatontown, NJ 07724 USA, NDC 0641-6 — West-Ward Pharmaceutical Corp.
-
February 16, 2015 · Class III · Terminated · D-0420-2015
Failed Impurities/Degradation Specifications; 12 month stability testing.
Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5 mL Single Dose Vials, For Intravenous or Intramuscular Use, Preservative Free, Rx Only, Manufactured by: West-Ward Pharmaceuticals, Eatontown, — West-Ward Pharmaceutical Corporation
-
December 3, 2014 · Class II · Terminated · D-0294-2015
Lack of Assurance of Sterility; improperly crimped fliptop vials
Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial (C-II), Rx only, 25 units per box/50 units per case, Hospira Inc., Lake Forest, IL --- NDC 0409-9094-61 — Hospira Inc.
-
June 27, 2014 · Class II · Terminated · D-1433-201
Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing.
Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Single-dose Fliptop Vial, Rx only. Hospira, Inc., Lake Forest, IL 60045. NDC: 0409-9094-61. — Hospira Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Fentanyl Citrate, Hospira, Inc., effective August 24, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →