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Prescription medicine · generic available

Acetaminophen

Also sold without a prescription: Acetaminophen (over the counter) →

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
4Recalls (FDA reports)
18Companies
2015First FDA approval on file

Quick answers

What is Acetaminophen used for?
The FDA-approved label (Acetaminophen, ProPharma Distribution, September 23, 2025) says: “Acetaminophen Injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older the reduction of fever in adult and pediatric patients. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Acetaminophen have a boxed warning?
Yes. The FDA label for Acetaminophen has a boxed warning (“WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
Is there a shortage of Acetaminophen?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Acetaminophen been recalled?
FDA enforcement reports list 4 recalls of products of this medicine; the newest started August 20, 2025 (Class II). A recall usually concerns specific lots, not every product.
Who makes Acetaminophen?
18 companies list prescription products of Acetaminophen in the FDA NDC Directory, including B. Braun Medical Inc., Hikma Pharmaceuticals USA Inc. and Baxter Healthcare Corporation.

What Acetaminophen is used for

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

Acetaminophen Injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older the reduction of fever in adult and pediatric patients. …

— FDA label: Acetaminophen, ProPharma Distribution, effective September 23, 2025. Read the full label on DailyMed →

The FDA has 21 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: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY. Read it on the full label →

20 of 21 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsInjection, solution · Injection
RouteIntravenous
Prescription products25 in the FDA NDC Directory

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

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA204767
ACETAMINOPHEN		 Fresenius Kabi USAOctober 28, 2015 3, latest July 28, 2021
2021: Labeling · 2021: Labeling · 2020: Labeling
NDA204957
ACETAMINOPHEN		 B Braun MedicalFebruary 18, 2021 —
NDA206968
ACETAMINOPHEN		 HikmaJune 3, 2022 1, latest May 28, 2024
2024: Labeling

Generic approvals (9)

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. August 20, 2025 · Class II · Ongoing · D-0596-2025

    Discoloration

    Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in Ireland, NDC 36000-306-60. — Baxter Healthcare Corporation

  2. July 8, 2024 · Class I · Ongoing · D-0635-2024

    Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)

    Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica (Portugal), SA, distributed by Hikma Pharmaceuticals USA Inc Berkel — Hikma Pharmaceuticals USA Inc.

  3. August 4, 2022 · Class II · Terminated · D-1348-2022

    Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled room temperature environment.

    Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Container, For Intravenous Use Only, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; NDC 36000-306-60 — Baxter Healthcare Corporation

  4. December 30, 2020 · Class II · Terminated · D-0248-2021

    Discoloration and failed pH specifications

    Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial, For Intravenous Use Only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Made in India NDC 55150-3 — AuroMedics Pharma 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)483017, 2480095, 2715604
SPL set ID of the quoted label3f7a6fdc-6e36-dc3e-e063-6394a90a067d
FDA labels (SPL)21
FDA applicationsNDA204767, NDA204957, NDA206968, 9 ANDA
Active ingredients (FDA)ACETAMINOPHEN

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Acetaminophen, ProPharma Distribution, effective September 23, 2025; 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 →

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