Ketamine Hydrochloride shortage — US supply status & alternatives

Ketamine Hydrochloride

—

In supply · Australia

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

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

Marketing-authorisation holders
Active ingredient (INN)	Ketamine Hydrochloride
Therapeutic category	Auto-created by U.S. Food and Drug Administration — Drug Shortages scraper
Controlled substance	No

Registrations on file	5

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.

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

6 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.

Moderate concentration risk

Arevipharma GMBHMaithri Drugs Private LTDGland Pharma LTDCu Chemie Uetikon GMBHFine Organics LTDSupriya Lifescience LTD

Manufacturing countries: Germany, India, United Kingdom · Source: FDA List of Drug Master Files

Recalls official enforcement reports

🇺🇸

Ketamine Hcl

Fresenius Kabi Compounding, LLC · Feb 2026

Class IIdetails ↗

🇫🇷

Ketamine Panpharma 10 mg/mL, solution injectable (I.V

I.M) – Laboratoire Panpharma · Dec 2025

Class ?details ↗

🇺🇸

Ketamine Hydrochloride

STAQ Pharma, Inc. · Oct 2025

Class IIIdetails ↗

🇺🇸

Ketamine Hcl

Denver Solutions, LLC DBA Leiters Health · Mar 2025

Class IIdetails ↗

🇺🇸

Ketamine Injection

Apollo Care, LLC · May 2023

Class IIdetails ↗

🇺🇸

Ketamine Hcl Usp For Prescription Compounding

American Pharmaceutical Ingredients LLC · Feb 2018

Class IIdetails ↗

Verified timeline regulator events

🇺🇸 1 Apr 2026

high reported

🇺🇸 5 Feb 2026

high reported

🇺🇸 7 Nov 2025

medium reported

🇺🇸 7 Nov 2025

medium reported

🇺🇸 9 Oct 2025

medium reported

🇺🇸 2 June 2025

high reported

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders5 registrations · 4 MA holders

Product	Strength	Form	Market	MA holder	Status
Ketamine Hydrochloride	50mg/mL	injection	🇺🇸 US	HIKMA PHARMACEUTICALS USA INC.	Active
Ketamine Hydrochloride	100mg/mL	injection	🇺🇸 US	HIKMA PHARMACEUTICALS USA INC.	Active
Ketamine Hydrochloride	10mg/mL	injection	🇺🇸 US	Sagent Pharmaceuticals	Active
Ketamine Hydrochloride Injection Usp	—	solution	🇨🇦 CA	SANDOZ CANADA INCORPORATED	Active
Ketamine Hydrochloride Injection, Usp	—	solution	🇨🇦 CA	FRESENIUS KABI CANADA LTD	Active

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.