Fluoxetine shortage — US supply status & alternatives

Fluoxetine

ATC N06AB03

🇦🇺 AUST R 401090 · Sandoz Pty Ltd

In supply · Australia

WHO Essential Medicine

Ach-Fluoxetine

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

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$3.50DPMQ A$18.10details →

✓ Can I substitute?

Per normal rules

Confirm with prescriber

⇄ Best alternative

Sertralina

◷ Expected back

Product attributes reference data we hold

Active ingredient (INN)	Fluoxetine
Brand names	Ach-Fluoxetine
ATC level 5	N06AB03
ATC level 4	N06AB
Therapeutic category	Auto-created by Health Canada — Drug Shortages Database scraper
WHO Essential Medicine	Yes (2023)
Controlled substance	No
Marketing-authorisation holders	Sandoz Pty Ltd, ACCORD-UK LIMITED, ROSEMONT PHARMACEUTICALS LIMITED, Generics (UK) Limited +8 more
Registrations on file	19
Patient information leaflet (PIL)	Not on file
Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 PBS · July 2026

🇦🇺 AU

● Official price on file

Ex-manufacturer

A$3.50

AEMP

Dispensed (DPMQ)

A$18.10

incl. fees

Pack

fluoxetine 20 mg capsule, 28

Source: PBSEffective July 2026 · AUD

Other markets

🇬🇧 GB

£1.39

Drug Tariff

🇮🇹 IT

€6.10

Retail price

🇫🇷 FR

€5.93

Retail price

🇪🇸 ES

€5.25

Retail price

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

12 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

Apitoria Pharma Private LTDErregierre SPAOlon SPAFermion OyTapi Nl BVQuimica Sintetica SA+6 more

Manufacturing countries: India, Italy, Finland, Spain, Switzerland · Source: FDA List of Drug Master Files

Recalls official enforcement reports

🇺🇸

FLUOXETINE

Torrent Pharma Inc. · May 2025

Class IIdetails ↗

🇺🇸

FLUOXETINE

Torrent Pharma Inc. · May 2025

Class IIdetails ↗

🇺🇸

FLUOXETINE

Teva Pharmaceuticals USA · Apr 2015

Class IIdetails ↗

🇺🇸

FLUOXETINE

Teva Pharmaceuticals USA · Apr 2015

Class IIdetails ↗

🇺🇸

Fluoxetine Hydrochloride Active Pharmaceutical Ingredient Pa

Attix Pharmaceuticals · Nov 2014

Class IIdetails ↗

🇺🇸

FLUOXETINE

Legacy Pharmaceutical Packaging · Feb 2014

Class IIdetails ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders19 registrations · 12 MA holders

Product	Strength	Form	Market	MA holder	Status
Blooms The Chemist	20mg	—	🇦🇺 AU	Sandoz Pty Ltd	Active
Fluoxetine-Wgr	20mg	—	🇦🇺 AU	—	Active
FLUOXETINE 20MG CAPSULES	20MG	capsule	🇬🇧 GB	ACCORD-UK LIMITED	Active
FLUOXETINE 20MG/5ML ORAL SOLUTION	20MG	solution	🇬🇧 GB	ROSEMONT PHARMACEUTICALS LIMITED	Active
FLUOXETINE 20MG CAPSULES, HARD	20MG	capsule	🇬🇧 GB	Generics (UK) Limited	Active
FLUOXETINE 60MG CAPSULES	60MG	capsule	🇬🇧 GB	Generics (UK) Limited	Active
FLUOXETINE 20 MG/5 ML ORAL SOLUTION	20 MG	solution	🇬🇧 GB	PINEWOOD LABORATORIES LIMITED	Active
FLUOXETINE 60MG HARD CAPSULES	60MG	capsule	🇬🇧 GB	DR REDDY'S LABORATORIES (UK) LIMITED	Active
FLUOXETINE 20 MG HARD CAPSULES	20 MG	capsule	🇬🇧 GB	MANX HEALTHCARE LIMITED	Active
FLUOXETINE 60 MG CAPSULES, HARD	60 MG	capsule	🇬🇧 GB	MILPHARM LIMITED	Active
FLUOXETINE 60 MG HARD CAPSULES	60 MG	capsule	🇬🇧 GB	BRISTOL LABORATORIES LIMITED	Active
FLUOXETINE 10MG HARD CAPSULES	10MG	capsule	🇬🇧 GB	MORNINGSIDE HEALTHCARE LIMITED	Active
FLUOXETINE 10MG CAPSULES, HARD	10MG	capsule	🇬🇧 GB	RELONCHEM LIMITED	Active
FLUOXETINE 30MG CAPSULES, HARD	30MG	capsule	🇬🇧 GB	RELONCHEM LIMITED	Active
FLUOXETINE 60MG CAPSULES, HARD	60MG	capsule	🇬🇧 GB	RELONCHEM LIMITED	Active

+4 more registrations on file

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.