Quick answers
- What is Haloperidol decanoate used for?
- The FDA-approved label (Haloperidol Decanoate, Patriot Pharmaceuticals LLC, February 19, 2025) says: “Haloperidol decanoate 50 and Haloperidol decanoate 100 are indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Haloperidol decanoate have a boxed warning?
- Yes. The FDA label for Haloperidol Decanoate has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Haloperidol decanoate?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated January 9, 2026). Ask your pharmacist about alternatives.
- Has Haloperidol decanoate been recalled?
- FDA enforcement reports list 12 recalls of products of this medicine; the newest started April 2, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Haloperidol decanoate?
- 16 companies list prescription products of Haloperidol decanoate in the FDA NDC Directory, including Somerset Therapeutics, LLC, BluePoint Laboratories and Remedyrepack Inc..
What Haloperidol decanoate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Haloperidol decanoate 50 and Haloperidol decanoate 100 are indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy.
— FDA label: Haloperidol Decanoate, Patriot Pharmaceuticals LLC, effective February 19, 2025. Read the full label on DailyMed →
The FDA has 20 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.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
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 →
19 of 20 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection · Injection, solution |
|---|---|
| Route | Intramuscular |
| Prescription products | 57 in the FDA NDC Directory |
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 |
|---|---|---|
| haloperidol decanoate 100 mg/mL injection | Generic | $7.40–$34.10 per mL 26 packages, lowest to highest |
| haloperidol decanoate 100 mg/mL injection, solution | Generic | $7.40 per mL |
| haloperidol decanoate 50 mg/mL injection | Generic | $6.46–$20.27 per mL 13 packages, lowest to highest |
| haloperidol decanoate 50 mg/mL injection, solution | Generic | $6.46 per mL |
| haloperidol decanoate 500 mg/5 mL injection | Generic | $16.64 per mL |
| haloperidol decanoate 500 mg/5 mL injection, solution | Generic | $16.64 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.
- Somerset Therapeutics, LLC9 products
- BluePoint Laboratories8 products
- Remedyrepack Inc.5 products
- Lifestar Pharma LLC4 products
- Zydus Pharmaceuticals USA Inc.4 products
- Zydus Lifesciences Limited4 products
- Caplin Steriles Limited3 products
- Armas Pharmaceuticals Inc.3 products
- Fresenius Kabi USA, LLC3 products
- Sagent Pharmaceuticals3 products
- Meitheal Pharmaceuticals Inc.3 products
- Hikma Pharmaceuticals USA Inc.2 products
- Gland Pharma Limited2 products
- Patriot Pharmaceuticals LLC2 products
- Mylan Institutional LLC2 products
- NorthStar RxLLC1 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 |
|---|---|---|---|
| NDA018701 HALDOL | Janssen Pharms | January 14, 1986 | 57, latest October 30, 2025 2025: Labeling · 2025: Labeling · 2020: Labeling |
Generic approvals (9)
- ANDA074893Fresenius Kabi USA · December 19, 1997
- ANDA075305Hikma · September 28, 1998
- ANDA075440Mylan Labs Ltd · February 28, 2000
- ANDA205241Gland · May 12, 2017
- ANDA209101Somerset Theraps LLC · July 3, 2018
- ANDA211180Zydus Pharms · October 22, 2019
- ANDA214507Meitheal · July 26, 2021
- ANDA216730Mankind Pharma · May 23, 2023
- ANDA219168Caplin · May 13, 2025
Shortage status
To be discontinued · updated January 9, 2026 · first posted January 9, 2026
| Product | Haloperidol Decanoate, Injection, 50 mg/1 mL (NDC 63323-469-05) |
|---|---|
| Company | Fresenius Kabi USA, LLC |
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.
-
April 2, 2025 · Class II · Ongoing · D-0369-2025
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics Limited, #54/1 Boodhihal Village, Nelamangala, Bangalore -562123, Karnataka, India, Manufactured for — Amerisource Health Services LLC
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April 2, 2025 · Class II · Ongoing · D-0368-2025
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured f — Amerisource Health Services LLC
-
April 2, 2025 · Class II · Ongoing · D-0367-2025
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for: Blu — Amerisource Health Services LLC
-
March 21, 2025 · Class II · Ongoing · D-0356-2025
Lack of Assurance of Sterility: Media fill with bacterial contamination
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Manufactured for: BluePoint Laboratories NDC 68001-580-41 — Somerset Therapeutics Private Limited
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March 21, 2025 · Class II · Ongoing · D-0357-2025
Lack of Assurance of Sterility: Media fill with bacterial contamination
Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India, Manufactured for: BluePoint Laboratories NDC 68001-581-41 (individual carton) and — Somerset Therapeutics Private Limited
-
March 21, 2025 · Class II · Ongoing · D-0358-2025
Lack of Assurance of Sterility: Media fill with bacterial contamination
Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-383-10 — Somerset Therapeutics Private Limited
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March 21, 2025 · Class II · Ongoing · D-0355-2025
Lack of Assurance of Sterility: Media fill with bacterial contamination
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-381-01 (individual carton) and NDC 70069-381-10 (10x1 mL carton) — Somerset Therapeutics Private Limited
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April 24, 2024 · Class II · Ongoing · D-0506-2024
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-Dose Vials (NDC 70069-381-10), Rx only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 3 — SOMERSET THERAPEUTICS LLC
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April 7, 2016 · Class III · Terminated · D-0818-2016
Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.
Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01. — Fresenius Kabi USA, LLC
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February 18, 2015 · Class II · Terminated · D-0421-2015
Lack of Assurance of Sterility; due to leaking vials
Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-409-00) packaged in cartons of five (NDC 67457-409-13), Rx only, Manufactured in India for: Mylan Institutional L — Mylan Institutional LLC
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February 18, 2015 · Class II · Terminated · D-0422-2015
Lack of Assurance of Sterility; due to leaking vials
Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-410-00) packaged in cartons of ten (NDC 67457-410-13), Rx only, Manufactured in India for: Mylan Institutional LLC — Mylan Institutional LLC
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April 14, 2014 · Class III · Terminated · D-0247-2015
Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.
HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01 — Fresenius Kabi USA LLC
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) | 859867, 859871, 1719803, 1719862 |
|---|---|
| SPL set ID of the quoted label | 9f0f42a8-5f7c-4be7-93ef-3ec225502cc6 |
| FDA labels (SPL) | 20 |
| FDA applications | NDA018701, 9 ANDA |
| Active ingredients (FDA) | HALOPERIDOL DECANOATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Haloperidol Decanoate, Patriot Pharmaceuticals LLC, effective February 19, 2025; 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 →