Tizanidine shortage — US supply status & alternatives

Tizanidine

—

In supply · Australia

Pal-Tizanidine

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

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

Active ingredient (INN)	Tizanidine
Brand names	Pal-Tizanidine

Controlled substance	No

Marketing-authorisation holders	TEVA UK LIMITED, Generics (UK) Limited, ACTAVIS PHARMA, INC., NCS HealthCare of KY, LLC dba Vangard Labs

Registrations on file	9

Patient information leaflet (PIL)	Not on file

Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 Australia · awaiting price ingest

🇦🇺 AU

Ex-manufacturer

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Dispensed (DPMQ)

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Pack

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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

£4.65

Drug Tariff

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

10 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

Farmak AsDr Reddys Laboratories LTDSun Pharmaceutical Industries LTDUnichem Laboratories LTDTapi Nl BVMatrix Pharmacorp Private LTD+4 more

Manufacturing countries: India · Source: FDA List of Drug Master Files

Recalls official enforcement reports

🇺🇸

TIZANIDINE

Dr. Reddy's Laboratories, Inc. · Jan 2024

Class IIdetails ↗

🇺🇸

TIZANIDINE

Preferred Pharmaceuticals, Inc. · June 2023

Class IIdetails ↗

🇺🇸

TIZANIDINE

Amerisource Health Services LLC · June 2023

Class IIdetails ↗

🇺🇸

TIZANIDINE

Dr Reddy's Laboratories Limited · June 2023

Class IIdetails ↗

🇺🇸

TIZANIDINE

Dr. Reddy's Laboratories, Inc. · July 2021

Class IIdetails ↗

🇺🇸

TIZANIDINE

Ascend Laboratories LLC · Nov 2020

Class IIdetails ↗

Verified timeline regulator events

🇳🇱 1 July 2026

medium reported

🇳🇱 18 May 2026

medium reported

🇳🇱 23 Apr 2026

medium reported

🇳🇱 10 Mar 2026

medium reported

🇺🇸 26 June 2023

high reported

🇺🇸 21 June 2023

high reported

Sources official regulators

🇨🇦

verified just now

verify ↗

🇳🇱

CBG-MEB

verified 2d ago

verify ↗

🇺🇸

FDA-FE

verified 2d ago

verify ↗

🇺🇸

FDA MedWatch

verified 1mo ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders9 registrations · 4 MA holders

Product	Strength	Form	Market	MA holder	Status
TIZANIDINE 2 MG TABLETS	2 MG	tablet	🇬🇧 GB	TEVA UK LIMITED	Active
TIZANIDINE 4 MG TABLETS	4 MG	tablet	🇬🇧 GB	TEVA UK LIMITED	Active
TIZANIDINE 2MG TABLETS	2MG	tablet	🇬🇧 GB	Generics (UK) Limited	Active
TIZANIDINE 4MG TABLETS	4MG	tablet	🇬🇧 GB	Generics (UK) Limited	Active
tizanidine hydrochloride	2mg/1	capsule	🇺🇸 US	ACTAVIS PHARMA, INC.	Active
tizanidine hydrochloride	4mg/1	capsule	🇺🇸 US	ACTAVIS PHARMA, INC.	Active
tizanidine hydrochloride	6mg/1	capsule	🇺🇸 US	ACTAVIS PHARMA, INC.	Active
tizanidine	2mg/1	tablet	🇺🇸 US	NCS HealthCare of KY, LLC dba Vangard Labs	Active
tizanidine	4mg/1	tablet	🇺🇸 US	NCS HealthCare of KY, LLC dba Vangard Labs	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.