What is Methylcobalamin injection (methyl B12)?

The short answer

Methylcobalamin injection is a shot of one of the forms of B12 that are found in food.

  • What it is

    Coenzyme form of vitamin B12.

  • What people look into

    Weight, brain

Get updates on Methylcobalamin injection (methyl B12)

What it is

Type
Vitamin (B12 coenzyme form)
Also known as
methylcobalamin, methyl b12 shot, mecobalamin
How it works
Coenzyme form of vitamin B12.

Regulatory status

Not FDA-approved · advisory vote June 2021 · no FDA decision How we label status

As of October 4, 2026, Methylcobalamin injection (methyl B12) is not FDA-approved. On June 9, 2021, FDA's compounding advisory committee voted to recommend adding it to the 503A bulks list; FDA staff had recommended against it. FDA has not proposed that change.

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Federal (FDA)
Not FDA-approved as a drug (openFDA: no application)
503A compounding
Category 1 (503A); PCAC recommended 2021-06-09 (9-5; FDA staff: against); no proposed rule as of 2026-10-07; 503B Category 1 (as of October 7, 2026)
PCAC history
PCAC 2021-06-09: 9-5 for; FDA staff: against
WADA 2026
Not named

References

Sources as of October 4, 2026

  1. FDA: www.fda.gov/media/94155/download
  2. FDA: www.fda.gov/media/94164/download
  3. Federal Register: www.federalregister.gov/documents/2021/05/07/2021-09621/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request
  4. Internet Archive: web.archive.org/web/20241109001606id_/https://www.fda.gov/media/151410/download
  5. Federal Register: www.federalregister.gov/documents/search