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Prescription medicine · generic available

Haloperidol

Also listed by the FDA as: haloperidol · haloperidol lactate

Drug class: Typical Antipsychotic

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

YesBoxed warning
None listedFDA shortage list
2Recalls (FDA reports)
33Companies
1986First FDA approval on file

Quick answers

What is Haloperidol used for?
The FDA-approved label (Haloperidol, Remedyrepack Inc., August 31, 2026) says: “Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Haloperidol have a boxed warning?
Yes. The FDA label for Haloperidol 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?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Haloperidol been recalled?
FDA enforcement reports list 2 recalls of products of this medicine; the newest started October 10, 2025 (Class II). A recall usually concerns specific lots, not every product.
Who makes Haloperidol?
33 companies list prescription products of Haloperidol in the FDA NDC Directory, including Bryant Ranch Prepack, Remedyrepack Inc. and Method Pharmaceuticals, LLC.

What Haloperidol is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). …

— FDA label: Haloperidol, Remedyrepack Inc., effective August 31, 2026. Read the full label on DailyMed →

The FDA has 83 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 →

82 of 83 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsTablet · Injection, solution · Solution · Injection · Solution, concentrate
RouteOral · Intramuscular
Prescription products175 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.

NADAC per unit for Haloperidol, by strength and form
Strength and formGeneric or brandPharmacies pay
haloperidol 0.5 mg
tablet		 Generic $0.0914 per tablet
haloperidol 1 mg
tablet		 Generic $0.1354 per tablet
haloperidol 10 mg
tablet		 Generic $0.1475 per tablet
haloperidol 2 mg
tablet		 Generic $0.1779 per tablet
haloperidol 2 mg/mL
solution		 Generic $0.1765–$0.6517 per mL
2 packages, lowest to highest
haloperidol 2 mg/mL
solution, concentrate		 Generic $0.1765–$0.6517 per mL
2 packages, lowest to highest
haloperidol 20 mg
tablet		 Generic $0.3595 per tablet
haloperidol 5 mg
tablet		 Generic $0.1711 per tablet
haloperidol lactate 2 mg/mL
solution		 Generic $0.1765–$0.6517 per mL
2 packages, lowest to highest
haloperidol lactate 5 mg/mL
injection		 Generic $0.7792 per mL
haloperidol lactate 5 mg/mL
injection, solution		 Generic $0.7792 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.

FDA approval history

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (16)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

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.

  1. October 10, 2025 · Class II · Ongoing · D-0214-2026

    Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.

    Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26605. NDC: 67457-426-12 with Safecor Health LL — Safecor Health, LLC

  2. March 15, 2021 · Class II · Terminated · D-0593-2021

    CGMP Deviations: Intermittent exposure to temperature excursion during storage.

    HALOPERIDOL TABLETS 20mg, USP, 100-count bottle, Rx Only Distributed by: Usher-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC: 0832-1560-11 — Cardinal Health 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)141935, 197754, 204416, 310670, 310671, 310672, 314034, 314035, 1719646
SPL set ID of the quoted labela0751f2e-05ab-4ba9-9bae-7b791bf1a621
FDA labels (SPL)83
FDA applications16 ANDA
Active ingredients (FDA)HALOPERIDOL

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Haloperidol, Remedyrepack Inc., effective August 31, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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 →

Report an error → · Information for medicine makers