Trazodone Hydrochloride shortage — US supply status & alternatives

Trazodone Hydrochloride

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In supply · Australia

Apo-Trazodone D

In supply · 🇦🇺 Australia · short in🇺🇸 US🇨🇦 CA🇮🇹 IT🇬🇷 GR

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)

Brand names	Apo-Trazodone D

Therapeutic category	Auto-created by Health Canada — Drug Shortages Database scraper

Controlled substance	No

Marketing-authorisation holders	ACCORD-UK LIMITED, Generics (UK) Limited, WAYMADE PLC, MERCURY PHARMACEUTICALS LIMITED +6 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

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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.

Substitution pathways 🇦🇺 Australia · TGA

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No substitution instrument in force

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

How long have past shortages lasted? from 2 resolved events

◷

~1 month

Historical pattern from resolved shortage records — not a prediction of this event.

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

14 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

Arene Life Sciences Private LTDMahi Drugs Private LTDFermion OyValdepharmMatrix Pharmacorp Private LTDTapi Nl BV+8 more

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

FDA-approved products 🇺🇸 Drugs@FDA

Approved applications

Generic (ANDA)

Brand (NDA/BLA)

Feb 2026

Latest approval

Shortage status by regulator official notices

🇺🇸

United States

FDA MedWatch · 2d ago

High

🇨🇦

Canada

HC · 4h ago

Medium

🇮🇹

Italy

AIFA · 1d ago

Medium

🇬🇷

EOF · 2d ago

Medium

Recalls official enforcement reports

🇺🇸

TRAZODONE HYDROCHLORIDE

Granules Pharmaceuticals Inc. · Jan 2026

Class IIdetails ↗

🇺🇸

TRAZODONE HYDROCHLORIDE

Zydus Pharmaceuticals (USA) Inc · Dec 2025

Class IIIdetails ↗

🇺🇸

TRAZODONE HYDROCHLORIDE

Cardinal Health Inc. · Mar 2021

Class IIdetails ↗

Verified timeline regulator events

🇨🇦 9 June 2026

medium reported

🇬🇷 15 May 2026

medium reported

🇬🇷 23 Apr 2026

Shortage resolved

🇮🇹 15 Mar 2026

medium reported

🇨🇦 25 Feb 2026

medium reported

🇺🇸 26 Jan 2026

high reported

Sources official regulators

🇨🇦

verified 4h ago

verify ↗

🇮🇹

AIFA

verified 1d ago

verify ↗

🇺🇸

FDA MedWatch

verified 2d ago

verify ↗

🇬🇷

EOF

verified 2d ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders20 registrations · 10 MA holders

Product	Strength	Form	Market	MA holder	Status
TRAZODONE HYDROCHLORIDE 50 MG CAPSULES	50 MG	capsule	🇬🇧 GB	ACCORD-UK LIMITED	Active
TRAZODONE HYDROCHLORIDE 100 MG CAPSULES	100 MG	capsule	🇬🇧 GB	ACCORD-UK LIMITED	Active
TRAZODONE HYDROCHLORIDE 150 MG TABLETS	150 MG	tablet	🇬🇧 GB	Generics (UK) Limited	Active
TRAZODONE HYDROCHLORIDE 50MG CAPSULES	50MG	capsule	🇬🇧 GB	Generics (UK) Limited	Active
TRAZODONE HYDROCHLORIDE 100MG CAPSULES	100MG	capsule	🇬🇧 GB	Generics (UK) Limited	Active
TRAZODONE HYDROCHLORIDE 150 MG FILM COATED TABLETS	150 MG	tablet	🇬🇧 GB	WAYMADE PLC	Active
TRAZODONE HYDROCHLORIDE 50MG/5ML ORAL SOLUTION	50MG	solution	🇬🇧 GB	MERCURY PHARMACEUTICALS LIMITED	Active
TRAZODONE HYDROCHLORIDE 150MG TABLETS	150MG	tablet	🇬🇧 GB	STRIDES PHARMA UK LIMITED	Active
TRAZODONE HYDROCHLORIDE 50MG CAPSULE, HARD	50MG	capsule	🇬🇧 GB	STRIDES PHARMA UK LIMITED	Active
TRAZODONE HYDROCHLORIDE 100MG CAPSULE, HARD	100MG	capsule	🇬🇧 GB	STRIDES PHARMA UK LIMITED	Active
TRAZODONE HYDROCHLORIDE 150 MG FILM-COATED TABLETS	150 MG	tablet	🇬🇧 GB	MANX HEALTHCARE LIMITED	Active
TRAZODONE HYDROCHLORIDE 50 MG/5 ML ORAL SOLUTION	50 MG	solution	🇬🇧 GB	MANX HEALTHCARE LIMITED	Active
TRAZODONE HYDROCHLORIDE 150MG FILM-COATED TABLETS	150MG	tablet	🇬🇧 GB	STRANDHAVEN LIMITED	Active
TRAZODONE HYDROCHLORIDE 50MG CAPSULES, HARD	50MG	capsule	🇬🇧 GB	STRANDHAVEN LIMITED	Active
TRAZODONE HYDROCHLORIDE 100MG CAPSULES, HARD	100MG	capsule	🇬🇧 GB	STRANDHAVEN LIMITED	Active

+5 more registrations on file

Mederti Drug Report

Generated 4 July 2026 · Australia market · 4 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.