Prescription medicine
Hydroxocobalamin Brand names: Cyanokit
Hydroxocobalamin (Cyanokit) is a prescription medicine with an FDA approval on record since 2006. FDA's NDC Directory lists it from 1 generic labeler, and pharmacies paid $0.814 per mL (Hydroxocobalamin 1,000 mcg/mL) in the October 7, 2026 NADAC survey.
- Generic listed
- In shortage
Check it at the source: the hydroxocobalamin FDA label on DailyMed (effective January 31, 2017, Actavis Pharma, Inc.); the NDA 22041 record on Drugs@FDA; every hydroxocobalamin label on DailyMed.
Highlights of the record
FDA label of January 31, 2017; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagePernicious anemia, both uncomplicated and accompanied by nervous system involvement.
Forms and strengths
- 5 g/250ml
Injection (solution); injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- December 15, 2006 Cyanokit, Btg Intl; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first April 18, 1975; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 1 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.814 per mL Hydroxocobalamin 1,000 mcg/mL
- Shortage (FDA)
- 2 of 2 presentations limited or unavailable updated October 1, 2026
- Recalls by its makers (FDA)
- 0 since 2012 0 Class I among all firms' recalls; 30 more by firms not listed as its makers
- FAERS reports
- 4,118 through July 30, 2026
What is hydroxocobalamin used for?
From the label: indications and usagePernicious anemia, both uncomplicated and accompanied by nervous system involvement. Dietary deficiency of Vitamin B 12 , occurring in strict vegetarians and in their breast-fed infants. (Isolated vitamin B 12 deficiency is very rare). Malabsorption of vitamin B 12 , resulting from structural or functional damage to the stomach, where intrinsic factor is secreted or to the ileum, where intrinsic factor facilitates vitamin B 12 absorption. These conditions include tropical sprue, and nontropical sprue (idiopathic steatorrhea, gluten-induced enteropathy). Folate deficiency in these patients is usually more severe than vitamin B 12 deficiency. […]
FDA pharmacologic class: Antidote.
Source: FDA drug label (Hydroxocobalamin), Actavis Pharma, Inc., effective January 31, 2017 (SPL set a3087a39-f218-4f16-a1e7-17c39bb2eb69), via openFDA; the full label on DailyMed
What does the patient leaflet for hydroxocobalamin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid after I receive CYANOKIT?CYANOKIT may cause red colored skin. Skin redness is common during treatment with CYANOKIT and may last up to 2 weeks after treatment with CYANOKIT. You should avoid sunlight while your skin is red.
Source: FDA drug label (Cyanokit), BTG INTERNATIONAL INC., effective April 27, 2023 (SPL set d56fcc8d-bd64-46ab-b0c0-2124bd745a6b), via openFDA; the full label on DailyMed
Is there a generic for hydroxocobalamin (Cyanokit)?
The FDA approved the first generic hydroxocobalamin on April 18, 1975. 3 generic applications are approved; 1 of them carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists hydroxocobalamin from 1 labeler under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2006 earliest approval on file
- 1975 first generic approved
- 2024 to now in shortage
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for hydroxocobalamin (Cyanokit)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.814 per mL (Hydroxocobalamin 1,000 mcg/mL), about the same as a year earlier. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Hydroxocobalamin 1,000 mcg/mL (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Hydroxocobalamin 1,000 mcg/mL | Generic | $0.814 per mL | n/a | -0.6% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is hydroxocobalamin in shortage?
The FDA Drug Shortage Database lists 2 of 2 hydroxocobalamin presentations as limited or unavailable (updated October 1, 2026); the first entry was posted on November 4, 2024.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Cyanokit, Injection, 5 g/250mL (NDC 50633-310-11) | BTG International Inc. | Current | October 1, 2026 |
| Hydroxocobalamin, Injection, 1000 MCG/ML, 30 ML Multi-Dose Vial (NDC 0591-2888-30) | Teva Pharmaceuticals USA, Inc. | Current | October 1, 2026 |
Every hydroxocobalamin presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has hydroxocobalamin been recalled?
The FDA's Enforcement Report lists 30 recalls naming hydroxocobalamin since 2012: 0 Class I (the most serious), 30 Class II, 0 Class III; 1 still ongoing. 30 of them are by firms that FDA's NDC Directory does not list as a maker of hydroxocobalamin and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 22, 2022 | Class II | Pharmacy Innovations not a listed maker | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. |
| March 7, 2022 | Class II | TMC Acquisition LLC dba Tailor Made Compounding not a listed maker | Lack of Assurance of Sterility |
| January 15, 2020 | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical not a listed maker | Lack of Assurance of Sterility |
| September 12, 2019 | Class II | KRS Global Biotechnology, Inc not a listed maker | Lack of Assurance of Sterility |
| June 26, 2019 | Class II | First Pharma Associates LLC dba Riverpoint Pharmacy not a listed maker | Lack of Assurance of Sterility. |
| June 19, 2019 | Class II | RXQ Compounding LLC not a listed maker | Lack of Assurance of Sterility |
| April 5, 2018 | Class II | Coastal Meds, LLC. not a listed maker | Presence of Particulate matter. Recall due to presence of unknown particulate matter. |
| November 16, 2017 | Class II | KRS Global Biotechnology, Inc not a listed maker | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the hydroxocobalamin label say about other medicines?
The hydroxocobalamin label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name hydroxocobalamin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Chloramphenicol | warnings | Blunted or impeded therapeutic response to vitamin B 12 may be due to such conditions as infection, uremia, drugs having bone marrow suppressant properties such as chloramphenicol, and concurrent iron or folic acid deficiency. |
| Cyanocobalamin | warnings and precautions | WARNINGS AND PRECAUTIONS Risk of Anaphylaxis and Other Hypersensitivity Reactions: Consider alternative therapies, if available, in patients with known anaphylactic reactions to hydroxocobalamin or cyanocobalamin. ( 5.2 ) Risk of Renal Injury: |
| Naproxen | warnings and precautions | ACL Futura (Instrumentation Laboratory), AxSYM ® /Architect ™ (Abbott), BM Coasys 110 (Boehringer Mannheim), CellDyn 3700 ® (Abbott), Clinitek ® 500 (Bayer), Cobas Integra ® 700, 400 (Roche), Gen-S Coultronics, Hitachi 917, STA ® Compact, Vitros ® 950 (Ortho Diagnostics) Clinical Chemistry Calcium Sodium Potassium … |
Source: FDA drug label (Hydroxocobalamin), Actavis Pharma, Inc., effective January 31, 2017 (SPL set a3087a39-f218-4f16-a1e7-17c39bb2eb69), via openFDA; the full label on DailyMed
What do FAERS reports show for hydroxocobalamin?
The FDA Adverse Event Reporting System holds 4,118 reports that list hydroxocobalamin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 311 are coded as a death and 1,636 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other antidotes
- the pharmacologic class, with prices and generics
- Hydroxocobalamin side effects
- the label's list beside FAERS reports
- Hydroxocobalamin shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other