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Hydromorphone Hydrochloride Injection shortage

Hydromorphone Hydrochloride Injection is currently listed in shortage by the FDA. The FDA lists 26 affected products. The reported reason: Other; Demand increase for the drug. This page was last refreshed from FDA data on Sep 25, 2026.

Current ⚠ Supply risk: Low Controlled substance Analgesia/Addiction 26 products 4 manufacturers 3,252 days · 8.9 yr First posted Oct 31, 2017 Updated Sep 22, 2026
Here’s the bottom line

Hydromorphone hydrochloride injection has been in shortage for over a year, driven by increased demand, and a few specific low-dose strengths currently have no available source. Most strengths are still listed by other manufacturers, including Hospira and Hikma Pharmaceuticals USA.

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 →
26
Affected NDCs
4
Reporting manufacturers
4/4
Reporting mfrs supplying
9/12
Affected strengths supplied
35%
NDCs unavailable
3,252
Days in shortage
181,509
Medicaid Rx (2026)
Source: FDA Drug Shortages Database API (openFDA). Last refreshed Sep 25, 2026 · yesterday

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 Hydromorphone Hydrochloride 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
26 NDCs
Available 14 Limited 3 Unavailable 9
Affected strengths still supplied
Among manufacturers reporting this shortage
9/12 strengths
Sourceable 9 No supply 3
FDA-reporting manufacturers with supply
Among manufacturers reporting this shortage
4/4 makers
With supply 4
✓ Other manufacturers not reporting a shortage
Still-marketed Hydromorphone Hydrochloride 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
Plus 16 alternative dosage forms of Hydromorphone Hydrochloride.
See all other options & details →
Shortage timeline
  1. Sep 22, 2026
    Currently in shortage
    26 of 26 products affected.
  2. Sep 18, 2026
    FDA refreshed this shortage record
    2 products updated.
  3. Sep 15, 2026
    FDA refreshed this shortage record
    13 products updated.
  4. Sep 9, 2026
    FDA refreshed this shortage record
    4 products updated.
  5. Nov 3, 2017
    More presentations reported
    1 more product added to the shortage.
  6. Nov 1, 2017
    More presentations reported
    9 more products added to the shortage.
  7. Oct 31, 2017
    First reported to the FDA
    16 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 10 NDCS click to expand
Status NDC / product Strength Availability Related information Reason
Current Dilaudid, Injection, 1 mg/1 mL (NDC 76045-009-11) NDC 76045-0009-11 — Unavailable Next release October 2026. Check wholesalers for inventory. Other
Current Dilaudid, Injection, 2 mg/1 mL (NDC 76045-010-11) NDC 76045-0010-11 — Unavailable Next release not available at this time. Check wholesalers for inventory. Other
Current Hydromorphone Hydrochloride, Injection, 2 mg/1 mL (NDC 63323-853-25) NDC 63323-0853-25 — Unavailable Next release September 2026. Check wholesalers for inventory. Other
Current Hydromorphone Hydrochloride, Injection, 10 mg/1 mL (NDC 63323-851-50) NDC 63323-0851-50 — Available Check wholesalers for inventory —
Current Hydromorphone Hydrochloride, Injection, 1 mg/1 mL (NDC 63323-852-25) NDC 63323-0852-25 — Unavailable Next release October 2026. Check wholesalers for inventory. Other
Current Dilaudid, Injection, 1 mg/1 mL (NDC 76045-009-06) NDC 76045-0009-06 — Unavailable Next release September 2026. Check wholesalers for inventory. Other
Current Hydromorphone Hydrochloride, Injection, 10 mg/1 mL (NDC 63323-851-15) NDC 63323-0851-15 — Available Check wholesaler for inventory —
Current Hydromorphone Hydrochloride, Injection, 4 mg/1 mL (NDC 63323-854-10) NDC 63323-0854-10 — Available Check wholesalers for inventory —
Current Dilaudid, Injection, .2 mg/1 mL (NDC 76045-121-11) NDC 76045-0121-11 — Unavailable Next release November 2026. Check wholesalers for inventory. Other
Current Hydromorphone Hydrochloride, Injection, 10 mg/1 mL (NDC 63323-851-10) NDC 63323-0851-10 — Available Check wholesalers for inventory —
Manufacturer: Hikma Pharmaceuticals USA, Inc. 📞 800-631-2174 2 NDCS click to expand
Status NDC / product Strength Availability Related information Reason
Current Hydromorphone Hydrochloride, Injection, 2 mg/1 mL (NDC 0641-0121-25) NDC 00641-0121-25 — Available Additional lots are scheduled for manufacturing to meet demand. Product will be made available as it is released. —
Current Hydromorphone Hydrochloride, Injection, 2 mg/1 mL (NDC 0641-6254-01) NDC 00641-6254-01 — Unavailable Product temporarily on backorder. Additional lots will be available in the September 2026 timeframe. Demand increase for the drug
Manufacturer: Hospira, Inc., a Pfizer Company 📞 844-646-4398 11 NDCS click to expand
Status NDC / product Strength Availability Related information Reason
Current Hydromorphone Hydrochloride, Injection, 50 mg/5 mL (10 mg/mL) (NDC 0409-2634-05) NDC 00409-2634-05 — Available — —
Current Hydromorphone Hydrochloride, Injection, 10 mg/1 mL (NDC 0409-2634-01) NDC 00409-2634-01 — Available — —
Current Hydromorphone Hydrochloride, Injection, 2 mg/1 mL (NDC 0409-3365-10) NDC 00409-3365-10 — Available — —
Current Hydromorphone Hydrochloride, Injection, 2 mg/1 mL Syringes (NDC 0409-1312-30) NDC 00409-1312-30 — Available — —
Current Hydromorphone Hydrochloride, Injection, 500 mg/50 mL (10 mg/mL) (NDC 0409-2634-50) NDC 00409-2634-50 — Available — —
Current Hydromorphone Hydrochloride, Injection, 1 mg/1 mL Syringes (NDC 0409-1283-31) NDC 00409-1283-31 — Available — —
Current Hydromorphone Hydrochloride, Injection, 4 mg/1 mL Syringes (NDC 0409-1304-31) NDC 00409-1304-31 — Available — —
Current Hydromorphone Hydrochloride, Injection, 2 mg/1 mL (NDC 0409-1312-36) NDC 00409-1312-36 — Limited Availability Limited Supply Available. Next Delivery: January 2027; Estimated Recovery: March 2027; Shortage per Manufacturer: Manufacturing Delay Other
Current Hydromorphone Hydrochloride, Injection, 1 mg/1 mL (NDC 0409-1283-37) NDC 00409-1283-37 — Unavailable Next Delivery: January 2027; Estimated Recovery: March 2027; Shortage per Manufacturer: Manufacturing Delay Other
Current Hydromorphone Hydrochloride, Injection, 0.25 mg/ 0.5 mL NexJect™ Single-dose Syringe Luer Lock (no needle) (NDC 0409-1805-01) NDC 00409-1805-01 — Unavailable Next Delivery and Estimated Recovery: December 2026; Shortage per Manufacturer: Manufacturing Delay Other
Current Hydromorphone Hydrochloride, Injection, 0.5 mg/0.5 mL NexJect™ Single-dose Syringe Luer Lock (no needle) (NDC 0409-4264-01) NDC 00409-4264-01 — Limited Supply Available. Next Delivery: September 2026; Estimated Recovery: December 2026 Limited Supply Available. Next Delivery: September 2026; Estimated Recovery: December 2026; Shortage per Manufacturer: Manufacturing Delay Other
Manufacturer: Teva Pharmaceuticals USA, Inc. 📞 800-545-8800 3 NDCS click to expand
Status NDC / product Strength Availability Related information Reason
Current Hydromorphone Hydrochloride, Injection, 10 mg/1 mL (NDC 0703-0113-03) NDC 00703-0113-03 — Limited Availability Estimated recovery: TBD Other
Current Hydromorphone Hydrochloride, Injection, 10 mg/1 mL (NDC 0703-0018-01) NDC 00703-0018-01 — Available — —
Current Hydromorphone Hydrochloride, Injection, 10 mg/1 mL (NDC 0703-0110-03) NDC 00703-0110-03 — Available — —

These rows are manufacturer reports to the FDA for Hydromorphone Hydrochloride 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 Hydromorphone Hydrochloride Injection? options further down this page.

Why is Hydromorphone Hydrochloride Injection in shortage?

Hydromorphone hydrochloride injection is on the FDA shortage list for two main reasons: more people need it than usual (higher demand), and some manufacturers are dealing with hold-ups at the factory. The shortage affects several specific products. From Fresenius Kabi, the Dilaudid 1 mg/1 mL and 0.2 mg/1 mL injections are currently unavailable, with next releases expected in September, October, and November 2026. Their 1 mg/1 mL generic version is also unavailable until around October 2026. From Hospira (Pfizer), the 2 mg/1 mL vials have limited supply with the next delivery expected January 2027 and full recovery around March 2027; the 0.25 mg/0.5 mL pre-filled syringe is unavailable until around December 2026; and the 0.5 mg/0.5 mL pre-filled syringe has limited supply with next delivery around September 2026 and recovery around December 2026. Hikma's 2 mg/1 mL vials are temporarily backordered, with more lots expected around September 2026. On the positive side, several strengths — including the 10 mg/1 mL, 4 mg/1 mL, and some 1 mg/1 mL syringe presentations — are currently showing as available from one or more of these manufacturers.

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 Hydromorphone Hydrochloride 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 Hydromorphone Hydrochloride Injection?

Hydromorphone Hydrochloride Injection is currently on the FDA drug-shortage list. This is a supply issue reported by the manufacturers who filed it, and many strengths of this medicine still have an available source.

Three strengths currently show no available source: the 1 mg/1 mL, the 0.25 mg/0.5 mL NexJect single-dose syringe, and the 0.2 mg/1 mL. Many other strengths do still have supply, including 2 mg/1 mL, 4 mg/1 mL, 10 mg/1 mL, 50 mg/5 mL, and several prefilled syringe products. So it helps to find the exact strength you use before drawing conclusions.

The reported reasons are increased demand and other supply factors, and this situation has lasted over a year. All four manufacturers on this record still report some available supply, and several list expected release dates through 2026 into 2027.

Here is what you can do:

  1. Do not stop, skip, or change your dose on your own.
  2. If your strength still has supply, ask your pharmacy to order it — they can check wholesalers and other manufacturers.
  3. The same medicine is made by more than one company, so your pharmacy may be able to source another maker's version, though it may not be in local stock.
  4. If your exact strength cannot be found, ask your prescriber or pharmacist about options.

Manufacturer contact numbers are listed on this page for reference; pharmacies usually handle those calls. This is national data and may not match your pharmacy's actual stock.

See “Where else can I get Hydromorphone Hydrochloride 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 Hydromorphone guide

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

Read the Hydromorphone guide →

Where else can I get Hydromorphone Hydrochloride 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 Hydromorphone Hydrochloride 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
Hydromorphone Hydrochloride HYDROMORPHONE HYDROCHLORIDE 1 mg/mL Injection, Solution · Intramuscular, Intravenous, Subcutaneous Hospira, Inc. 00409-1283-05
Hydromorphone Hydrochloride HYDROMORPHONE HYDROCHLORIDE 2 mg/mL Injection · Intramuscular, Intravenous, Subcutaneous Hikma Pharmaceuticals USA Inc. 00641-2341-41
Hydromorphone Hydrochloride HYDROMORPHONE HYDROCHLORIDE 1 mg/mL Injection · Intramuscular, Intravenous, Subcutaneous Hikma Pharmaceuticals USA Inc. 00641-6169-10
Hydromorphone Hydrochloride HYDROMORPHONE HYDROCHLORIDE .5 mg/.5mL Injection · Intramuscular, Intravenous, Subcutaneous Hikma Pharmaceuticals USA Inc. 00641-6206-10
Hydromorphone Hydrochloride HYDROMORPHONE HYDROCHLORIDE .2 mg/mL Injection · Intramuscular, Intravenous, Subcutaneous Hikma Pharmaceuticals USA Inc. 00641-6259-10
Dilaudid HYDROMORPHONE HYDROCHLORIDE 1 mg/mL Injection, Solution · Intramuscular, Intravenous, Subcutaneous Fresenius Kabi USA, LLC 76045-0009-05
Dilaudid HYDROMORPHONE HYDROCHLORIDE 2 mg/mL Injection, Solution · Intramuscular, Intravenous, Subcutaneous Fresenius Kabi USA, LLC 76045-0010-10

Alternative dosage forms of Hydromorphone Hydrochloride

A different form of the same drug (for example a solution when capsules are short). A form change is a clinical decision — ask your prescriber:

Therapeutic equivalents & pricing 12 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
Hydromorphone Hydrochloride 2 mg/mLNDC 00641-6151-25 Hikma 25 vials $2.740 AP Availability likely
Hydromorphone Hydrochloride 2 mg/mLNDC 63323-0853-25 Fresenius 25 vials $2.740 AP Availability likely
Hydromorphone Hydrochloride 2 mg/mLNDC 00409-1312-30 Hospira, 10 cartridges $3.245 — Availability likely
Hydromorphone Hydrochloride 1 mg/mLNDC 63323-0852-25 Fresenius 25 vials — AP FDA listed
Dilaudid 1 mg/mLNDC 76045-0009-11 Fresenius 10 syringes — AP FDA listed
Hydromorphone Hydrochloride 1 mg/mLNDC 00409-1283-05 Hospira, 10 syringes — — FDA listed
Hydromorphone Hydrochloride 1 mg/mLNDC 00641-6169-10 Hikma 10 syringes — AP FDA listed
Hydromorphone Hydrochloride 2 mg/mLNDC 00641-6170-10 Hikma 10 syringes — AP FDA listed
Dilaudid 2 mg/mLNDC 76045-0010-11 Fresenius 10 syringes — AP FDA listed
Hydromorphone Hydrochloride 2 mg/mLNDC 00409-3365-10 Hospira, 10 vials — — FDA listed
Hydromorphone Hydrochloride 2 mg/mLNDC 00641-2341-41 Hikma 20 vials — — FDA listed
Hydromorphone Hydrochloride 2 mg/mLNDC 00641-6254-01 Hikma 1 vial — — 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 Hydromorphone Hydrochloride Injection — that fall in the same broad treatment class (opioid analgesics) . 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 062823
GCN 98594
HICL code 034805
Ingredient (HICL) Hydromorphone Hcl/Pf
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H3
Therapeutic class — intermediate (HIC2) Analgesics
HIC3 code H3A
Therapeutic class — specific (HIC3) Opioid Analgesics
AHFS code 28:08.08.00
AHFS class Opioid Agonists (28:08)
FDB label name DILAUDID 1 MG/ML SYRINGE
FDB brand name Dilaudid
Legend status F — Federal legend — prescription drug or device
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 shortages

Hydromorphone Hydrochloride Injection shortage FAQs

Is Hydromorphone Hydrochloride Injection in shortage?
Yes — the FDA currently lists Hydromorphone Hydrochloride Injection in shortage (status: “Current”, first reported Oct 31, 2017). 26 of 26 products are affected. This is national, manufacturer-reported data, so your pharmacy may still have stock.
Why is Hydromorphone Hydrochloride 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; Shortage per Manufacturer: Manufacturing Delay.
Which products are affected?
Dilaudid, Injection, 1 mg/1 mL (NDC 76045-009-11) (NDC 76045-0009-11); Dilaudid, Injection, 2 mg/1 mL (NDC 76045-010-11) (NDC 76045-0010-11); Hydromorphone Hydrochloride, Injection, 2 mg/1 mL (NDC 63323-853-25) (NDC 63323-0853-25). The full per-NDC list (availability, manufacturer and status) is in the table above — each NDC links to its own page.
When will Hydromorphone Hydrochloride Injection be available again?
The manufacturer reports: Limited Supply Available. Next Delivery: September 2026; Estimated Recovery: December 2026; Shortage per Manufacturer: Manufacturing Delay. The FDA does not publish a single guaranteed restock date — confirm with your pharmacy.
Can I still get Hydromorphone Hydrochloride somewhere?
Other manufacturers (Hospira, Inc., Hikma Pharmaceuticals USA Inc., Fresenius Kabi USA, LLC) still market it and have not reported a shortage. 16 alternative dosage forms of Hydromorphone Hydrochloride are also listed. See “Where else can I get Hydromorphone Hydrochloride Injection?” above — stock still varies by pharmacy.
What should I do if I take Hydromorphone Hydrochloride 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 Hydromorphone Hydrochloride 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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