Home › NDC Lookup › Drug shortages › Haloperidol Decanoate Injection

Haloperidol Decanoate Injection shortage

Haloperidol Decanoate Injection is currently listed in shortage by the FDA. The FDA lists 2 affected products. This page was last refreshed from FDA data on Oct 2, 2026.

To Be Discontinued ⚠ Supply risk: High Psychiatry 2 products 267 days First posted Jan 9, 2026 Updated Jan 9, 2026
Here’s the bottom line

Fresenius Kabi is permanently stopping production of haloperidol decanoate injection 50 mg/mL. Other makers — including Hikma, Patriot Pharmaceuticals, Sagent, and Janssen — still list both the 50 mg/mL and 100 mg/mL strengths as available.

Don’t stop or change your therapy on your own — talk with your prescriber about the plan that fits you, and ask your pharmacist what’s actually available (see options).

Do you take this drug? See the ‘What to do’ recommendation from Dr. Brian Staiger, PharmD →
2
Affected NDCs
1
Reporting manufacturers
0/1
Reporting mfrs supplying
0/1
Affected strengths supplied
267
Days in shortage
546
Medicaid Rx (2026)
Source: FDA Drug Shortages Database API (openFDA). Last refreshed Oct 2, 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 Haloperidol Decanoate 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
2 NDCs
To be discontinued 2
Affected strengths still supplied
Among manufacturers reporting this shortage
0/1 strengths
No supply 1
FDA-reporting manufacturers with supply
Among manufacturers reporting this shortage
0/1 makers
No supply 1
✓ Other manufacturers not reporting a shortage
Still-marketed Haloperidol Decanoate Injection from companies that have not filed an FDA shortage — these are not counted in the figures above. Stock can still vary by pharmacy.
Hikma Pharmaceuticals USA Inc. Patriot Pharmaceuticals LLC Sagent Pharmaceuticals Janssen Pharmaceuticals, Inc. Fresenius Kabi USA, LLC Caplin Steriles Limited Mylan Institutional LLC
See all other options & details →
Shortage timeline
  1. Jan 9, 2026
    Currently in shortage
    2 of 2 products affected.
  2. Jan 9, 2026
    First reported to the FDA
    2 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 2 NDCS click to expand
Status NDC / product Strength Availability Related information Reason
To Be Discontinued Haloperidol Decanoate, Injection, 50 mg/1 mL (NDC 63323-469-01) NDC 63323-0469-01 — — Discontinuation of the manufacture of the drug —
To Be Discontinued Haloperidol Decanoate, Injection, 50 mg/1 mL (NDC 63323-469-05) NDC 63323-0469-05 — — Discontinuation of the manufacture of the drug —

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

Why is Haloperidol Decanoate Injection in shortage?

Fresenius Kabi USA has decided to permanently stop making their version of Haloperidol Decanoate Injection 50 mg/1 mL. This affects two specific package sizes they carried (NDC 63323-469-05 and NDC 63323-469-01). They haven't shared a specific public reason for why they made this decision — just that manufacturing of this product is being discontinued.

It's worth knowing that this report only covers Fresenius Kabi's products. Other manufacturers of haloperidol decanoate may not be part of this shortage report and could have their own separate listings on the FDA shortage page.

Based on the manufacturer-reported reason(s) and notes on file with the FDA for Haloperidol Decanoate 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 Haloperidol Decanoate Injection?

Haloperidol Decanoate Injection is currently listed on the FDA drug-shortage report. This note is to help you understand what that means for the strength you take.

The strength affected here is 50 mg/1 mL, which does not have an available source right now. The reason given is that the manufacturer who filed this report, Fresenius Kabi USA, is discontinuing its production of this product. Because this is listed as a discontinuation rather than a temporary delay, this particular supply problem may be permanent. That said, this report reflects only one manufacturer, and other companies make the same medicine.

Please do not let that last part worry you — this is a long-acting injection usually given by a clinician, and there are steps to keep your treatment on track.

  • First, do not skip or change your dose on your own.
  • Ask your pharmacy to check wholesalers and other makers; the same medicine (haloperidol decanoate injection) is listed as available from makers such as Hikma, Sagent, Janssen (Haldol Decanoate), Patriot, Caplin Steriles, and Mylan — though it may not be in local stock.
  • Because this product is being discontinued, talk with your prescriber about a suitable plan, which may include the same medicine from another maker.

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

See “Where else can I get Haloperidol Decanoate 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.
Keep reading
Our full Haloperidol guide

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

Read the Haloperidol guide →

Where else can I get Haloperidol Decanoate 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 Haloperidol Decanoate 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
Haloperidol Decanoate HALOPERIDOL DECANOATE 100 mg/mL Injection · Intramuscular Hikma Pharmaceuticals USA Inc. 00143-9295-01
Haloperidol Decanoate HALOPERIDOL DECANOATE 50 mg/mL Injection · Intramuscular Patriot Pharmaceuticals LLC 10147-0921-03
Haloperidol Decanoate HALOPERIDOL DECANOATE 100 mg/mL Injection · Intramuscular Patriot Pharmaceuticals LLC 10147-0922-05
Haloperidol Decanoate HALOPERIDOL DECANOATE 50 mg/mL Injection, Solution · Intramuscular Sagent Pharmaceuticals 25021-0831-01
Haloperidol Decanoate HALOPERIDOL DECANOATE 100 mg/mL Injection, Solution · Intramuscular Sagent Pharmaceuticals 25021-0833-01
Haloperidol Decanoate HALOPERIDOL DECANOATE 500 mg/5mL Injection, Solution · Intramuscular Sagent Pharmaceuticals 25021-0834-05
Haldol Decanoate HALOPERIDOL DECANOATE 50 mg/mL Injection · Intramuscular Janssen Pharmaceuticals, Inc. 50458-0253-03
Haldol Decanoate HALOPERIDOL DECANOATE 100 mg/mL Injection · Intramuscular Janssen Pharmaceuticals, Inc. 50458-0254-14
Haloperidol Decanoate HALOPERIDOL DECANOATE 100 mg/mL Injection · Intramuscular Fresenius Kabi USA, LLC 63323-0471-01
Haloperidol Decanoate HALOPERIDOL DECANOATE 100 mg/mL Injection · Intramuscular Caplin Steriles Limited 65145-0167-10
Haloperidol Decanoate HALOPERIDOL DECANOATE 50 mg/mL Injection · Intramuscular Caplin Steriles Limited 65145-0168-10
Haloperidol Decanoate HALOPERIDOL DECANOATE 100 mg/mL Injection · Intramuscular Mylan Institutional LLC 67457-0409-13
Therapeutic equivalents & pricing 24 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
haloperidol decanoate 50 mg/mLNDC 25021-0831-01 Sagent 10 vials $6.572 save 47% AO Availability likely
Haloperidol Decanoate 50 mg/mLNDC 67457-0410-13 Mylan 10 vials $6.572 save 47% AO Availability likely
Haloperidol Decanoate 50 mg/mLNDC 71288-0502-02 Meitheal 10 vials $6.572 save 47% AO Availability likely
Haloperidol Decanoate 50 mg/mLNDC 70069-0866-10 Somerset 10 vials $6.572 save 47% AO Availability likely
Haloperidol decanoate 50 mg/mLNDC 70710-1461-06 Zydus 10 vials $6.572 save 47% AO Availability likely
Haloperidol Decanoate 50 mg/mLNDC 65145-0168-10 Caplin 10 vials $6.572 save 47% AO Availability likely
Haloperidol Decanoate 50 mg/mLNDC 72485-0520-10 Armas 10 vials $6.572 save 47% AO Availability likely
Haloperidol Decanoate 50 mg/mLNDC 70756-0615-10 Lifestar 10 vials $6.572 save 47% AO Availability likely
Haloperidol decanoate 50 mg/mLNDC 68001-0657-51 BluePoint 3 vials $12.052 save 3% AO Availability likely
Haloperidol Decanoate 50 mg/mLNDC 63323-0469-01 Fresenius 1 vial $12.467 AO Availability likely
Haloperidol Decanoate 50 mg/mLNDC 70069-0381-01 Somerset 1 vial $12.678 +2% AO Availability likely
Haloperidol Decanoate 50 mg/mLNDC 68001-0580-41 BluePoint 1 vial $12.748 +2% AO Availability likely
Haloperidol Decanoate 50 mg/mLNDC 68001-0578-48 BluePoint 3 ampules $20.085 +61% AO FDA listed
Haloperidol Decanoate 50 mg/mLNDC 10147-0921-03 Patriot 3 ampules $20.085 +61% — FDA listed
Haloperidol Decanoate 50 mg/mLNDC 70069-0030-03 Somerset 3 ampules $20.753 +66% AO Availability likely
Haloperidol Decanoate 50 mg/mLNDC 70069-0382-01 Somerset 1 vial — AO FDA listed
Haloperidol decanoate 50 mg/mLNDC 70771-1851-06 Zydus 10 vials — AO FDA listed
Haloperidol decanoate 50 mg/mLNDC 70771-1852-01 Zydus 1 vial — AO FDA listed
Haloperidol decanoate 50 mg/mLNDC 70710-1462-01 Zydus 1 vial — AO FDA listed
Haloperidol Decanoate 50 mg/mLNDC 70518-4670-00 REMEDYREPACK 10 vials — AO FDA listed
Haloperidol Decanoate 50 mg/mLNDC 70518-3743-00 REMEDYREPACK 10 vials — AO FDA listed
Haloperidol Decanoate 50 mg/mLNDC 68083-0137-02 Gland 1 vial — AO FDA listed
Haldol Decanoate 50 mg/mLNDC 50458-0253-03 Janssen 3 ampules — — Discontinued
Haloperidol Decanoate 50 mg/mLNDC 63323-0469-05 Fresenius 1 vial — AO 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 Haloperidol Decanoate Injection — that fall in the same broad treatment class (antipsychotics,dopamine antagonists,butyrophenones) . 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 003967
GCN 14780
HICL code 001660
Ingredient (HICL) Haloperidol Decanoate
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H7
Therapeutic class — intermediate (HIC2) Psychoactive Drugs (Continued 1)
HIC3 code H7O
Therapeutic class — specific (HIC3) Antipsychotics,Dopamine Antagonists,Butyrophenones
AHFS code 28:16.08.08
AHFS class Butyrophenones
FDB label name HALOPERIDOL DEC 50 MG/ML VIAL
FDB brand name Haloperidol Decanoate
Legend status F — Federal legend — prescription drug or device
GPI-1459100010302010
GPI classHaloperidol Decanoate
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 psychiatry shortages

Haloperidol Decanoate Injection shortage FAQs

Is Haloperidol Decanoate Injection in shortage?
Yes — the FDA currently lists Haloperidol Decanoate Injection in shortage (status: “To Be Discontinued”, first reported Jan 9, 2026). 2 of 2 products are affected. This is national, manufacturer-reported data, so your pharmacy may still have stock.
Which products are affected?
Haloperidol Decanoate, Injection, 50 mg/1 mL (NDC 63323-469-01) (NDC 63323-0469-01); Haloperidol Decanoate, Injection, 50 mg/1 mL (NDC 63323-469-05) (NDC 63323-0469-05). The full per-NDC list (availability, manufacturer and status) is in the table above — each NDC links to its own page.
When will Haloperidol Decanoate Injection be available again?
The FDA does not publish a guaranteed restock date, and no estimated-recovery note is on file. Availability can change daily — confirm with your pharmacy.
Can I still get Haloperidol Decanoate somewhere?
Other manufacturers (Hikma Pharmaceuticals USA Inc., Patriot Pharmaceuticals LLC, Sagent Pharmaceuticals and others) still market it and have not reported a shortage. See “Where else can I get Haloperidol Decanoate Injection?” above — stock still varies by pharmacy.
What should I do if I take Haloperidol Decanoate 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.

Still have a question about the Haloperidol Decanoate 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.
← Back to all current drug shortages