Acetaminophen shortage — US supply status & alternatives

Acetaminophen

ATC N02BE01

In supply · Australia

In supply · 🇦🇺 Australia · short in🇺🇸 US🇨🇦 CA

In supply in Australia

Reading today’s signals…

✓ Can I substitute?

In supply

no shortage substitution needed

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

No estimate

No estimate provided

Product attributes reference data we hold

Controlled substance
Active ingredient (INN)	Acetaminophen
ATC level 5	N02BE01
ATC level 4	N02BE
Therapeutic category	Canonical INN head (inn_resolution)

Marketing-authorisation holders	HIKMA PHARMACEUTICALS USA INC., PAI Holdings, LLC dba PAI Pharma, UPSHER-SMITH LABORATORIES, LLC, B. Braun Medical Inc. +2 more

Registrations on file	20

Patient information leaflet (PIL)	Not on file

Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 Australia · awaiting price ingest

🇦🇺 AU

Ex-manufacturer

—

Dispensed (DPMQ)

—

Pack

—

Not yet captured for Australia

Official pricing isn’t on file for this market yet. PBS (Australia), NHS Drug Tariff (United Kingdom) and CMS NADAC (United States) feeds are prioritised; this panel populates automatically once the data lands.

Other markets

🇬🇧 GB

£6.31

Drug Tariff

🇺🇸 US

US$0.02

Acquisition

🇪🇸 ES

€1.31

Retail price

🇫🇷 FR

€1.08

Retail price

Substitution pathways 🇦🇺 Australia · TGA

—

No substitution instrument in force

Dispense per normal rules, or refer to the prescriber. No active SSSI/S19A instrument detected for this medicine.

Global API supply base 🇺🇸 FDA Drug Master Files · active Type II

15 API manufacturers

Manufacturers with an active Type II Drug Master File — i.e. cleared to supply this active ingredient into the US market. A proxy for how concentrated the global manufacturing base is.

Low concentration risk

Iol Chemicals And Pharmaceuticals LTDSpecgx LLCAnqui Luan Pharmaceutical CO LTDAtabay Kimya Sanayi Ve Ticaret AsSri Krishna Pharmaceuticals LTDZhejiang Kangle Pharmaceutical CO LTD+9 more

Manufacturing countries: India, United States, Turkey, China · Source: FDA List of Drug Master Files

FDA-approved products 🇺🇸 Drugs@FDA

Approved applications

Generic (ANDA)

Brand (NDA/BLA)

Dec 2025

Latest approval

Shortage status by regulator official notices

🇺🇸

United States

FDA MedWatch · 2d ago

High

🇨🇦

Canada

HC · just now

Medium

Recalls official enforcement reports

🇺🇸

TYLENOL EXTRA STRENGTH

Kenvue Brands LLC · Oct 2025

Class IIdetails ↗

🇨🇦

Acetaminophen

Communications and Public Affairs Branch · Sept 2025

Class ?details ↗

🇺🇸

ACETAMINOPHEN

Baxter Healthcare Corporation · Aug 2025

Class IIdetails ↗

🇺🇸

AMAZON BASIC CARE ACETAMINOPHEN

Aurobindo Pharma USA Inc · May 2025

Class IIdetails ↗

🇺🇸

Acetaminophen

Akron Pharma, Inc. · Dec 2024

Class IIIdetails ↗

🇺🇸

Acetaminophen

Granules Consumer Health Inc. · July 2024

Class IIIdetails ↗

Verified timeline regulator events

🇨🇦 3 June 2026

medium reported

🇨🇦 12 May 2026

medium reported

🇨🇦 14 Apr 2026

medium reported

🇨🇦 10 Feb 2026

medium reported

🇨🇦 13 Jan 2026

medium reported

🇺🇸 17 Oct 2025

high reported

Sources official regulators

🇨🇦

verified just now

verify ↗

🇺🇸

FDA MedWatch

verified 2d ago

verify ↗

🇺🇸

ANSM Ruptures

verified 1mo ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders20 registrations · 6 MA holders

Product	Strength	Form	Market	MA holder	Status
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	300; 50; 40; 30mg/1; mg/1; mg/1; mg/1	capsule	🇺🇸 US	HIKMA PHARMACEUTICALS USA INC.	Active
Hydrocodone Bitartrate And Acetaminophen	300; 10mg/15mL; mg/15mL	liquid	🇺🇸 US	HIKMA PHARMACEUTICALS USA INC.	Active
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	325; 50; 40; 30mg/1; mg/1; mg/1; mg/1	capsule	🇺🇸 US	HIKMA PHARMACEUTICALS USA INC.	Active
Hydrocodone Bitartrate and Acetaminophen	325; 7.5mg/15mL; mg/15mL	solution	🇺🇸 US	PAI Holdings, LLC dba PAI Pharma	Active
Acetaminophen	650mg/20.3mL	suspension	🇺🇸 US	PAI Holdings, LLC dba PAI Pharma	Active
Hydrocodone Bitartrate and Acetaminophen	108; 2.5mg/5mL; mg/5mL	solution	🇺🇸 US	PAI Holdings, LLC dba PAI Pharma	Active
Acetaminophen	160mg/5mL	solution	🇺🇸 US	PAI Holdings, LLC dba PAI Pharma	Active
Dye Free Childrens Acetaminophen	160mg/5mL	suspension	🇺🇸 US	PAI Holdings, LLC dba PAI Pharma	Active
Acetaminophen and Codeine Phosphate	300; 30mg/12.5mL; mg/12.5mL	solution	🇺🇸 US	PAI Holdings, LLC dba PAI Pharma	Active
Acetaminophen	325mg/10.15mL	solution	🇺🇸 US	PAI Holdings, LLC dba PAI Pharma	Active
Hydrocodone Bitartrate and Acetaminophen	217; 5mg/10mL; mg/10mL	solution	🇺🇸 US	PAI Holdings, LLC dba PAI Pharma	Active
Childrens Acetaminophen	160mg/5mL	suspension	🇺🇸 US	PAI Holdings, LLC dba PAI Pharma	Active
Acetaminophen	1000mg/100mL	injection	🇺🇸 US	HIKMA PHARMACEUTICALS USA INC.	Active
Hydrocodone Bitartrate and Acetaminophen	325; 5mg/1; mg/1	tablet	🇺🇸 US	UPSHER-SMITH LABORATORIES, LLC	Active
Hydrocodone Bitartrate and Acetaminophen	325; 7.5mg/1; mg/1	tablet	🇺🇸 US	UPSHER-SMITH LABORATORIES, LLC	Active

+5 more registrations on file

Mederti Drug Report

Generated 4 July 2026 · Australia market · 3 regulatory sources

For health-professional reference only. Mederti aggregates shortage and substitution information from official regulatory sources. It is not clinical advice and data may be incomplete or delayed. Confirm any substitution or supply decision against the primary regulator source, the prescriber, and current clinical references (e.g. AMH) before acting. Terms.