Quick answers
- What is Hydroxocobalamin used for?
- The FDA-approved label (Cyanokit, Btg International Inc., April 27, 2023) says: “CYANOKIT is indicated for the treatment of known or suspected cyanide poisoning. CYANOKIT is indicated for the treatment of known or suspected cyanide poisoning.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Hydroxocobalamin have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Hydroxocobalamin?
- The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 19, 2026). Ask your pharmacist about alternatives.
- Has Hydroxocobalamin been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Hydroxocobalamin?
- 1 company lists prescription products of Hydroxocobalamin in the FDA NDC Directory, including BTG International Inc.
What Hydroxocobalamin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
CYANOKIT is indicated for the treatment of known or suspected cyanide poisoning. CYANOKIT is indicated for the treatment of known or suspected cyanide poisoning.
— FDA label: Cyanokit, Btg International Inc., effective April 27, 2023. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Cyanokit |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- BTG International Inc1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022041 CYANOKIT | Btg Intl | December 15, 2006 | 11, latest December 31, 2018 2018: Labeling · 2018: Labeling · 2016: Manufacturing (CMC) |
Shortage status
Current shortage · updated October 19, 2026 · first posted November 4, 2024
| Product | Cyanokit, Injection, 5 g/250mL (NDC 50633-310-11) |
|---|---|
| Availability | Limited Availability |
| Reason given | Other |
| Company | BTG International Inc. |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 700496, 700499 |
|---|---|
| SPL set ID of the quoted label | d56fcc8d-bd64-46ab-b0c0-2124bd745a6b |
| FDA labels (SPL) | 1 |
| FDA applications | NDA022041 |
| Active ingredients (FDA) | HYDROXOCOBALAMIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cyanokit, Btg International Inc., effective April 27, 2023; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →