Hydroxocobalamin shortage — US supply status & alternatives

Hydroxocobalamin

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🇦🇺 AUST R 161606 · Aspen Pharmacare Australia Pty Ltd

In supply · Australia

In supply · 🇦🇺 Australia · short in🇺🇸 US🇨🇦 CA🌐 EU🇧🇪 BE

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$3.97DPMQ A$18.57details →

✓ Can I substitute?

Per normal rules

Confirm with prescriber

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

No estimate

No estimate provided

Product attributes reference data we hold

Active ingredient (INN)	Hydroxocobalamin
Therapeutic category	Auto-created by U.S. Food and Drug Administration — Drug Shortages scraper
Controlled substance	No
Marketing-authorisation holders	MERCURY PHARMACEUTICALS LIMITED, RPH PHARMACEUTICALS AB, Aspen Pharmacare Australia Pty Ltd, Pfizer Australia Pty Ltd +3 more
Registrations on file	8
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$3.97

AEMP

Dispensed (DPMQ)

A$18.57

incl. fees

Pack

hydroxocobalamin 1 mg/mL injection, 3 x 1 mL ampoules

Source: PBSEffective July 2026 · AUD

Other markets

🇬🇧 GB

£11.75

concession

🇺🇸 US

US$0.81

Acquisition

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

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

Hebei Huarong Pharmaceutical CO LTDEuroapi FranceSupriya Lifescience LTD

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

Recalls official enforcement reports

🇺🇸

Hydroxocobalamin

Pharmacy Innovations · Dec 2022

Class IIdetails ↗

🇺🇸

Hydroxocobalamin

TMC Acquisition LLC dba Tailor Made Compounding · Mar 2022

Class IIdetails ↗

🇺🇸

Hydroxocobalamin

Vita Pharmacy, LLC dba Talon Compounding Pharmacy · Oct 2021

Class IIdetails ↗

🇺🇸

Hydroxocobalamin

Vita Pharmacy, LLC dba Talon Compounding Pharmacy · Oct 2021

Class IIdetails ↗

🇺🇸

Hydroxocobalamin

KRS Global Biotechnology, Inc · Sept 2019

Class IIdetails ↗

🇺🇸

Hydroxocobalamin

KRS Global Biotechnology, Inc · Sept 2019

Class IIdetails ↗

Verified timeline regulator events

🇨🇦 12 June 2026

high reported

🇨🇦 20 May 2026

high reported

🌐 19 Dec 2024

high reported

🇺🇸 4 Nov 2024

critical reported

🇧🇪 30 Nov 2023

medium reported

🇧🇪 1 Dec 2022

medium reported

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders8 registrations · 7 MA holders

Product	Strength	Form	Market	MA holder	Status
HYDROXOCOBALAMIN 1MG/ML SOLUTION FOR INJECTION	1MG	injection	🇬🇧 GB	MERCURY PHARMACEUTICALS LIMITED	Active
Hydroxocobalamin 1000micrograms/Ml Solution For	1000MICROGRAM	injection	🇬🇧 GB	RPH PHARMACEUTICALS AB	Active
HYDROXO-B12 hydroxocobalamin chloride	1mg	—	🇦🇺 AU	Aspen Pharmacare Australia Pty Ltd	Active
NEO-B12 INJECTION Hydroxocobalamin	1000 microgram	—	🇦🇺 AU	Pfizer Australia Pty Ltd	Active
VITA-B12 INJECTION hydroxocobalamin acetate	1mg	—	🇦🇺 AU	Amdipharm Mercury Australia Pty Ltd	Active
COBAL-B12 INJECTION hydroxocobalamin acetate	1mg	—	🇦🇺 AU	Amdipharm Mercury Australia Pty Ltd	Active
Hydroxocobalamin	1000ug/mL	injection	🇺🇸 US	ACTAVIS PHARMA, INC.	Active
Hydroxocobalamin Inj	1000MCG	liquid	🇨🇦 CA	E L STICKLEY AND CO 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.