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PEPLUX

Vitamin B12, methyl form

Methylcobalamin B12

Also called Methyl B12, Mecobalamin.

  • Energy
  • Cognition
Illustrative PEPLUX product vial in a purple-lit studio
Product illustration

Product form

Subcutaneous injection

The process

Licensed provider review

Methylcobalamin B12 cost

$229 per month

*If medically eligible.
Medication
Included
Clinician visit
Included
Baseline labs
Included
Lab retests
Included when ordered by your provider
Shipping
Included
Patient portal access
Included
Care-team chat support
Included

Considering more than one product?

  • Two products prescribed together: $349 per month
  • Three products prescribed together: $479 per month
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Compounded medications are not approved by the FDA and have not been reviewed for safety, effectiveness, or quality.

FDA status, checked on October 13, 2026
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In FDA's Category 1 for 503A pharmacies and 503B outsourcing facilities: interim enforcement discretion, not the bulks list.

*If medically eligible.

Compounded medications are not approved by the FDA and have not been reviewed for safety, effectiveness, or quality.

PEPLUX is a telehealth platform, not a pharmacy or drug manufacturer. Medications are compounded and dispensed by independently licensed US compounding pharmacies.

Prescription products require an online evaluation with a licensed provider. Not all patients qualify.

States served: not yet confirmed. How state availability works

What is Methylcobalamin B12?

Methylcobalamin, the methyl form of vitamin B12. Not cyanocobalamin or hydroxocobalamin.

Adults who want to discuss injected vitamin B12 with a licensed provider. Whether testing comes first, and whether an injection is appropriate at all, is the provider's decision.

Key risks

  • Reported side effects include injection site pain or redness, diarrhea, itching and rash.
  • Serious allergic reactions, including anaphylaxis, have been reported with injected vitamin B12. Not for anyone with a known allergy to cobalt or to any form of vitamin B12.
All risks and who should not use it

FDA status

FDA status for Methylcobalamin B12.

Rendered from our regulatory records, which cite FDA, Federal Register and label documents directly. Each record shows the date we last checked it.

In FDA's Category 1 for 503A pharmacies and 503B outsourcing facilities: interim enforcement discretion, not the bulks list.

Methylcobalamin B12

FDA interim enforcement discretion (Category 1). Not a listing. Not FDA-approved.

FDA’s documents list it as Methylcobalamin.

Methylcobalamin is in FDA's Category 1 for both 503A pharmacies and 503B outsourcing facilities. Category 1 means FDA is still evaluating the substance and has said it does not intend to take action against compounding with it while its interim policy's conditions are met. That is enforcement discretion, not a listing, and FDA can change it. Compounded methylcobalamin is not FDA-approved. FDA does not check the safety, effectiveness or quality of compounded drugs before they are sold.

FDA lists it as "Methylcobalamin" in 503A Category 1 and as "Methylcobalamin/Methyl B12" in 503B Category 1.

Basis
FDA's 503A categories document (updated May 14, 2026) lists "Methylcobalamin" in Category 1, bulk drug substances under evaluation. FDA's 503B categories document (updated March 21, 2025) lists "Methylcobalamin/Methyl B12" in Category 1. Methylcobalamin is not on the 503A bulks list in 21 CFR 216.23 and not on the 503B bulks list. Category 1 is FDA's interim enforcement discretion, not a statutory pathway.
Checked on
October 13, 2026

How it works

Methylcobalamin B12 mechanism.

Methylcobalamin is an active coenzyme form of vitamin B12, required for methionine synthase activity and for normal hematopoiesis and neurological function.

That describes what the molecule does in the body. It is not a claim about what it will do for you.

What the evidence supports

Methylcobalamin B12: evidence and limitations.

Most of the clinical evidence for vitamin B12 comes from other forms, cyanocobalamin and hydroxocobalamin, and studies showing an advantage for the methyl form are limited. In people whose B12 levels are already adequate, supplementation has no demonstrated benefit, and a provider decides whether testing comes first.

Risks

Methylcobalamin B12 risks and side effects.

  • Reported side effects include injection site pain or redness, diarrhea, itching and rash.
  • Serious allergic reactions, including anaphylaxis, have been reported with injected vitamin B12. Not for anyone with a known allergy to cobalt or to any form of vitamin B12.
  • Safety data specific to injected methylcobalamin are more limited than for the more widely used forms of B12.

This information is educational and is not medical advice. It does not establish a provider–patient relationship.

Clinical review

What your prescriber will consider.

These are decision factors a licensed provider weighs when deciding whether this product is appropriate for you. They are not instructions, and there is no dosing protocol on this page.

  • Serum B12, and methylmalonic acid where the picture is unclear

  • The underlying cause of any deficiency, which matters more than the injection

  • Oral repletion, which is adequate for most people

PEPLUX does not publish self-administration protocols. Dose, frequency and duration are set by your prescriber against your own history and reviewed over time.

Lot documents

What a certificate of analysis should cover.

When a pharmacy is named, each lot's certificate of analysis is expected to cover the tests below. No certificate exists or is published yet.

  • Potency
  • Sterility
  • Endotoxin
  • pH

Sport and anti-doping

WADA status.

  • Not named on the WADA 2026 Prohibited List.

The list is revised every year. If you compete, check the current list and your federation’s own rules.

Straight answers

Common questions about Methylcobalamin B12.

What is the FDA status of Methylcobalamin B12?
In FDA's Category 1 for 503A pharmacies and 503B outsourcing facilities: interim enforcement discretion, not the bulks list. Methylcobalamin is in FDA's Category 1 for both 503A pharmacies and 503B outsourcing facilities. Category 1 means FDA is still evaluating the substance and has said it does not intend to take action against compounding with it while its interim policy's conditions are met. That is enforcement discretion, not a listing, and FDA can change it. Compounded methylcobalamin is not FDA-approved. FDA does not check the safety, effectiveness or quality of compounded drugs before they are sold. Checked against primary sources on October 13, 2026.
Is compounded Methylcobalamin B12 an approved drug?
No. Compounded medications are not approved by the FDA and have not been reviewed for safety, effectiveness, or quality. PEPLUX is a telehealth platform, not a pharmacy or drug manufacturer. Medications are compounded and dispensed by independently licensed US compounding pharmacies.
What does the evidence support for Methylcobalamin B12, and what does it not?
Most of the clinical evidence for vitamin B12 comes from other forms, cyanocobalamin and hydroxocobalamin, and studies showing an advantage for the methyl form are limited. In people whose B12 levels are already adequate, supplementation has no demonstrated benefit, and a provider decides whether testing comes first.
What are the risks of Methylcobalamin B12?
Reported side effects include injection site pain or redness, diarrhea, itching and rash. The full list of side effects, and of who should not use Methylcobalamin B12, is in the risks section of this page. Your prescriber reviews your history before deciding whether it is appropriate for you.
Why does Methylcobalamin B12 require baseline labs?
Yes. A prescriber reviews baseline labs before a first prescription of Methylcobalamin B12. Baseline labs are included in the price.
What does Methylcobalamin B12 cost?
$229 per month. Medication: included. Clinician visit: included. Baseline labs: included. Lab retests: included when ordered by your provider. Shipping: included. Patient portal access: included. Care-team chat support: included. *If medically eligible.
Is Methylcobalamin B12 prohibited in sport?
Not named on the WADA 2026 Prohibited List.
How is Methylcobalamin B12 given?
Subcutaneous injection. Your prescriber decides whether it is appropriate for you and sets the regimen. PEPLUX does not publish dosing.

Next step

A licensed provider reviews every request.

Order now

In FDA's Category 1 for 503A pharmacies and 503B outsourcing facilities: interim enforcement discretion, not the bulks list.

*If medically eligible.

Compounded medications are not approved by the FDA and have not been reviewed for safety, effectiveness, or quality.

Also offered

Other products.

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