Quick answers
- What is Hydromorphone hydrochloride used for?
- The FDA-approved label (Dilaudid, Fresenius Kabi USA, LLC, July 15, 2026) says: “DILAUDID INJECTION is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Limitations of Use: • Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy […], reserve opioid analgesics, including DILAUDID INJECTION for use in patients for whom …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Hydromorphone hydrochloride have a boxed warning?
- Yes. The FDA label for Dilaudid has a boxed warning (“WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF DILAUDID INJECTION”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Hydromorphone hydrochloride?
- The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 21, 2026). Ask your pharmacist about alternatives.
- Has Hydromorphone hydrochloride been recalled?
- FDA enforcement reports list 9 recalls of products of this medicine; the newest started February 7, 2018 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Hydromorphone hydrochloride?
- 17 companies list prescription products of Hydromorphone hydrochloride in the FDA NDC Directory, including Hospira, Inc., Rhodes Pharmaceuticals LLC and Fresenius Kabi USA, LLC.
What Hydromorphone hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
DILAUDID INJECTION is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Limitations of Use: • Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy […], reserve opioid analgesics, including DILAUDID INJECTION for use in patients for whom …
— FDA label: Dilaudid, Fresenius Kabi USA, LLC, effective July 15, 2026. Read the full label on DailyMed →
The FDA has 28 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. Its heading: WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF DILAUDID INJECTION
. Read it on the full label →
28 of 28 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Injection, solution · Tablet, extended release · Injection · Solution |
|---|---|
| Route | Oral · Intramuscular · Intravenous · Subcutaneous |
| Prescription products | 69 in the FDA NDC Directory |
| Brand names | Dilaudid |
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 |
|---|---|---|
| hydromorphone hydrochloride 1 mg/mL solution | Generic | $0.2341 per mL |
| hydromorphone hydrochloride 10 mg/mL injection, solution | Generic | $2.57 per mL |
| hydromorphone hydrochloride 12 mg tablet, extended release | Generic | $10.58 per tablet |
| hydromorphone hydrochloride 16 mg tablet, extended release | Generic | $12.38 per tablet |
| hydromorphone hydrochloride 2 mg tablet | Generic | $0.1708 per tablet |
| hydromorphone hydrochloride 2 mg/mL injection | Generic | $2.74 per mL |
| hydromorphone hydrochloride 2 mg/mL injection, solution | Generic | $2.74 per mL |
| hydromorphone hydrochloride 4 mg tablet | Generic | $0.2202 per tablet |
| hydromorphone hydrochloride 5 mg/5 mL solution | Generic | $0.2341 per mL |
| hydromorphone hydrochloride 8 mg tablet | Generic | $0.5490 per tablet |
| hydromorphone hydrochloride 8 mg tablet, extended release | Generic | $5.71 per tablet |
NADAC list of November 4, 2026; these prices took effect between May 20, 2026 and 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.
- Hospira, Inc.9 products
- Rhodes Pharmaceuticals LLC8 products
- Fresenius Kabi USA, LLC7 products
- Hikma Pharmaceuticals USA Inc.7 products
- XLCare Pharmaceuticals, Inc.4 products
- Padagis US LLC4 products
- Ascent Pharmaceuticals Inc4 products
- Camber Pharmaceuticals, Inc.4 products
- Trigen Laboratories, LLC4 products
- Teva Parenteral Medicines, Inc.3 products
- Aurolife Pharma, LLC3 products
- Bryant Ranch Prepack3 products
- American Health Packaging3 products
- Asclemed USA, Inc.3 products
- SpecGx LLC3 products
- St. Mary's Medical Park Pharmacy1 product
- Redpharm Drug1 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 |
|---|---|---|---|
| NDA019034 DILAUDID, DILAUDID-HP | Fresenius Kabi USA | January 11, 1984 | 18, latest December 22, 2025 2025: Labeling · 2023: Labeling · 2020: Manufacturing (CMC) |
| NDA019891 DILAUDID | Rhodes Pharms | December 7, 1992 | 20, latest June 18, 2026 2026: REMS · 2025: Labeling · 2024: REMS |
| NDA019892 DILAUDID | Rhodes Pharms | December 7, 1992 | 21, latest June 18, 2026 2026: REMS · 2025: Labeling · 2024: REMS |
| NDA200403 HYDROMORPHONE HYDROCHLORIDE | Hospira Inc | December 1, 2011 | 9, latest December 22, 2025 2025: Labeling · 2023: Labeling · 2019: Labeling |
| NDA217812 HYDROMORPHONE HYDROCHLORIDE | Hikma | December 14, 2023 | 1, latest December 22, 2025 2025: Labeling |
Generic approvals (11)
- ANDA074653Hikma · July 29, 1998
- ANDA076855Specgx LLC · December 23, 2004
- ANDA078591Hospira Inc · June 17, 2008
- ANDA204278Padagis Us · April 6, 2015
- ANDA205814Aurolife Pharma LLC · May 13, 2016
- ANDA205629Osmotica Pharm Us · July 7, 2016
- ANDA210176Ascent Pharms Inc · October 27, 2017
- ANDA210506Ascent Pharms Inc · January 17, 2018
- ANDA202159Hikma · April 27, 2018
- ANDA212133Ascent Pharms Inc · September 23, 2020
- ANDA216899Hikma · February 9, 2024
Shortage status
Current shortage · updated October 21, 2026 · first posted October 31, 2017
| Product | Hydromorphone Hydrochloride, Injection, 50 mg/5 mL (10 mg/mL) (NDC 0409-2634-05) |
|---|---|
| Availability | Available |
| 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.
-
February 7, 2018 · Class I · Terminated · D-0596-2018
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618. NDC: 0703-0110-01 — Pfizer Inc.
-
February 7, 2018 · Class I · Terminated · D-0597-2018
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Hospira, Inc., Lake forest, IL 60045 USA. NDC: 0409-2634-01 — Pfizer Inc.
-
August 22, 2017 · Class II · Terminated · D-1167-2017
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3365-11 (carton) and 0409-3365-01(vial) — Pfizer Inc.
-
July 26, 2017 · Class II · Terminated · D-1080-2017
Presence of Particulate Matter: Silicone oil
Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618 USA. NDC: 0703-0018-01 — HOSPIRA INC, LAKE FOREST
-
July 26, 2017 · Class II · Terminated · D-1081-2017
Presence of Particulate Matter: Silicone oil
Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial per Carton, 100 vials per case. Hospira, Inc., Lake Forest, IL 60045 USA, NDC: 0409-2634-50 — HOSPIRA INC, LAKE FOREST
-
July 26, 2017 · Class II · Terminated · D-1082-2017
Presence of Particulate Matter: Silicone oil
Hydromorphone Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Single Dose Vial.(10 vials per carton NDC 0703-0113-01) and 180 vials per case (NDC 0703-0113-03) Mfd By: Hospira, Inc., Lake Forest, IL 60045 USA, — HOSPIRA INC, LAKE FOREST
-
October 1, 2014 · Class II · Terminated · D-0044-2015
Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be broken or cracked.
Hydromorphone Hydrochloride Injection, USP, 10 mg/mL, Rx only, packaged in a) 1 mL Single-dose Vial (NDC 0703-0110-01), packaged in 10 x 1 mL Single-dose Vials per carton (NDC 0703-0110-03); Mfd By: Hospira Inc., Lake Fo — Hospira Inc.
-
August 15, 2012 · Class I · Terminated · D-020-2013
Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has been found to be overfilled and contain more than the 1 mL labeled fill volume.
HYDROmorphone HCl Injection, USP, 2 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged in 10-count Carpujects per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1312-30, Barcode (0 — Hospira Inc.
-
May 12, 2012 · Class I · Terminated · D-1444-2012
Superpotent (Single Ingredient) Drug: Some of the prefilled cartridge units have been found to be overfilled and contain more than the 1 mL labeled fill volume.
HYDROmorphone HCl Injection, USP, 1 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged in 10-count Carpujects per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1283-31, Barcode (0 — 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
| RxCUI (RxNorm) | 897653, 897657, 897658, 897696, 897698, 897702, 897704, 897710, 897712, 897745 … (+10) |
|---|---|
| SPL set ID of the quoted label | 9eebd88a-5632-460f-b7b6-26c8a180540d |
| FDA labels (SPL) | 28 |
| FDA applications | NDA019034, NDA019891, NDA019892, NDA200403, NDA217812, 11 ANDA |
| Active ingredients (FDA) | HYDROMORPHONE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Dilaudid, Fresenius Kabi USA, LLC, effective July 15, 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 →