Morphine shortage — US supply status & alternatives

Morphine

ATC N02AA01 · Strong opioid analgesic

🇦🇺 AUST R 288827 · Wockhardt Bio Pty Ltd

In shortage · Australia

WHO Essential MedicineControlled substance

KapanolOramorph Sevredol MS Contin

In declared shortage · 🇦🇺 Australia & also short in🇺🇸 US🇨🇦 CA🇬🇧 GB🇳🇿 NZ🇧🇪 BE🇮🇪 IE

Critical shortage

Reading today’s signals…

Product attributes reference data we hold

Active ingredient (INN)	Morphine
Brand names	Kapanol, Oramorph, Sevredol, MS Contin
ATC level 5	N02AA01
ATC level 4	N02AA
Drug class	Strong opioid analgesic
Therapeutic category	Analgesic
Strength	5mg · 10mg · 15mg · 20mg · 30mg · 60mg · 100mg
Dosage form	tablet · modified-release tablet · oral solution · solution for injection
Route of administration	oral · intravenous · subcutaneous · intramuscular
WHO Essential Medicine	Yes · 1.3. Preoperative medication and sedation for short-term procedures (2023)
Controlled substance	Yes — scheduled
Marketing-authorisation holders	Wockhardt Bio Pty Ltd, MARTINDALE PHARMACEUTICALS LIMITED, HAMELN PHARMA LTD, MACARTHYS LABORATORIES LIMITED +7 more
Registrations on file	27
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$3.85

AEMP

Dispensed (DPMQ)

A$24.18

incl. fees

Pack

morphine hydrochloride trihydrate 10 mg/mL injection, 5 x 1 mL ampoules

tablet

Source: PBSEffective July 2026 · AUD

Other markets

🇬🇧 GB

£5.45

concession

🇫🇷 FR

€9.30

Retail price

🇺🇸 US

US$0.88

Acquisition

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

3 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.

High concentration risk

Specgx LLCNoramco LLCVeranova LP

Manufacturing countries: United States · Source: FDA List of Drug Master Files

Shortage status by regulator official notices

🇺🇸

United States

FDA · 1h ago

Critical

🇦🇺

Australia

TGA · 1h ago

Critical

🇨🇦

Canada

HC · 7h ago

High

🇳🇿

New Zealand

Pharmac · 3h ago

High

🇬🇧

United Kingdom

MHRA · 7h ago

High

🇧🇪

FAMHP · 9d ago

Medium

🇮🇪

Ireland

HPRA · 1mo ago

Medium

Recalls official enforcement reports

🇺🇸

MORPHINE SULFATE

Winder Laboratories, LLC · Nov 2025

Class IIIdetails ↗

🇺🇸

Morphine Sulfate

Safecor Health, LLC · Feb 2025

Class IIdetails ↗

🇺🇸

MORPHINE SULFATE

SUN PHARMACEUTICAL INDUSTRIES INC · Feb 2025

Class IIdetails ↗

🇺🇸

INFUMORPH 200

Hikma Pharmaceuticals USA Inc. · Mar 2024

Class IIdetails ↗

🇺🇸

OPIUM TINCTURE DEODORIZED

Edenbridge Pharmaceuticals, LLC · Oct 2023

Class IIIdetails ↗

🇺🇸

Morphine Sulfate (A) 1Mg/Ml In Ns 350Ml

Sentara Infusion Services · Dec 2022

Class IIdetails ↗

Sources official regulators

🇨🇦

verified 1h ago

verify ↗

🇺🇸

FDA

verified 1h ago

verify ↗

🇦🇺

TGA

verified 1h ago

verify ↗

🇳🇿

Pharmac

verified 3h ago

verify ↗

🇬🇧

MHRA

verified 7h ago

verify ↗

🇧🇪

FAMHP

verified 9d ago

verify ↗

🇺🇸

FDA MedWatch

verified 1mo ago

verify ↗

🇮🇪

HPRA

verified 1mo ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders27 registrations · 11 MA holders

Product	Strength	Form	Market	MA holder	Status
APOMORPHINE WOCKHARDT apomorphine hydrochloride hemihydrate	10 mg	—	🇦🇺 AU	Wockhardt Bio Pty Ltd	Active
MORPHINE ORAL SOLUTION 10MG/5ML	10MG	solution	🇬🇧 GB	MARTINDALE PHARMACEUTICALS LIMITED	Active
Morphine Sulfate	10 MG	injection	🇬🇧 GB	HAMELN PHARMA LTD	Active
Morphine Sulfate	1 MG	injection	🇬🇧 GB	HAMELN PHARMA LTD	Active
Morphine Sulfate	10MG	injection	🇬🇧 GB	MACARTHYS LABORATORIES LIMITED	Active
Morphine Sulfate	15MG	injection	🇬🇧 GB	MACARTHYS LABORATORIES LIMITED	Active
Morphine Sulfate	20MG	injection	🇬🇧 GB	MACARTHYS LABORATORIES LIMITED	Active
Morphine Sulfate	30MG	injection	🇬🇧 GB	MACARTHYS LABORATORIES LIMITED	Active
Diamorphine Hydrochloride	10MG	tablet	🇬🇧 GB	AURUM PHARMACEUTICALS LIMITED	Active
Morphine Sulphate Injection Bp	1MG	injection	🇬🇧 GB	AURUM PHARMACEUTICALS LIMITED	Active
Morphine Sulphate Injection Bp	2 MG	injection	🇬🇧 GB	AURUM PHARMACEUTICALS LIMITED	Active
Kaolin And Morphine Mixture	—	kaolin	🇬🇧 GB	LCM LIMITED	Active
Morphine Sulphate Injection Bp	10MG	injection	🇬🇧 GB	BRISTOL LABORATORIES LIMITED	Active
Morphine Sulphate Injection Bp	15MG	injection	🇬🇧 GB	BRISTOL LABORATORIES LIMITED	Active
Morphine Sulphate Injection Bp	30MG	injection	🇬🇧 GB	BRISTOL LABORATORIES LIMITED	Active

+12 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.