Prescription medicine
Cyanocobalamin Brand names: Nascobal; first approved as Vi-Twel
Cyanocobalamin (Nascobal) is a prescription medicine with an FDA approval on record since 1949. FDA's NDC Directory lists it from 23 generic labelers, and pharmacies paid $1.47 per mL (Cyanocobalamin 1,000 mcg/mL vial) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the cyanocobalamin FDA label on DailyMed (effective October 31, 2023, American Regent, Inc.); the NDA 7012 record on Drugs@FDA; every cyanocobalamin label on DailyMed.
Highlights of the record
FDA label of October 31, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageCyanocobalamin is indicated for vitamin B 12 deficiencies due to malabsorption which may be associated with the following conditions: Addisonian (pernicious) anemia Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomy Fish tapeworm infestation Malignancy of pancreas or bowel Folic acid deficiency It may be possible to
Forms and strengths
Injection (solution); injection; spray; spray (metered).
On the market
- Earliest approval on file
- September 15, 1949 Vi-Twel, Bayer Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 26 first October 20, 1971; 17 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 24 of which 23 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $1.47 per mL Cyanocobalamin 1,000 mcg/mL vial
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 7 since 2012 1 Class I among all firms' recalls; latest July 24, 2026; 22 more by firms not listed as its makers
- FAERS reports
- 32,744 through July 30, 2026
What is cyanocobalamin used for?
From the label: indications and usageCyanocobalamin is indicated for vitamin B 12 deficiencies due to malabsorption which may be associated with the following conditions: Addisonian (pernicious) anemia Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomy Fish tapeworm infestation Malignancy of pancreas or bowel Folic acid deficiency It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see Drug Interactions ), use of a gluten-free diet in nontropical sprue, or administration of antibiotics in tropical sprue. […]
Conditions named in the indications of cyanocobalamin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Vitamin B12.
Source: FDA drug label (Cyanocobalamin), American Regent, Inc., effective October 31, 2023 (SPL set 2fb653d6-e2b2-4969-831b-c0dc37b9c0cc), via openFDA; the full label on DailyMed
Is there a generic for cyanocobalamin (Nascobal)?
The FDA approved the first generic cyanocobalamin on October 20, 1971. 26 generic applications are approved; 17 of them carry 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 cyanocobalamin from 23 labelers 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.
- 1949 earliest approval on file
- 1971 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for cyanocobalamin (Nascobal)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.47 per mL (Cyanocobalamin 1,000 mcg/mL vial), down 11% from $1.65 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. 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.
- Cyanocobalamin 1,000 mcg/mL vial (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Cyanocobalamin 1,000 mcg/mL vial | Generic | $1.47 per mL | n/a | -11% |
| Cyanocobalamin 10,000 mcg/10 mL | Generic | $0.739 per mL | n/a | -16% |
| Cyanocobalamin 30,000 mcg/30 mL | Generic | $0.670 per mL | n/a | -9% |
| Cyanocobalamin 500 mcg spray | Generic | $95.91 per unit | n/a | +2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has cyanocobalamin been recalled?
The FDA's Enforcement Report lists 29 recalls naming cyanocobalamin since 2012: 1 Class I (the most serious), 26 Class II, 2 Class III; 2 still ongoing. 22 of them are by firms that FDA's NDC Directory does not list as a maker of cyanocobalamin 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 |
|---|---|---|---|
| July 24, 2026 | Class II | American Regent, Inc. | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde |
| June 27, 2024 | Class II | Zydus Pharmaceuticals (USA) Inc | Presence of particulate matter: glass |
| May 9, 2022 | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy not a listed maker | Lack of assurance of sterility. |
| April 12, 2022 | Class III | American Health Packaging | Subpotent Drug: Out of specification for assay. |
| April 5, 2022 | Class III | Aurobindo Pharma USA Inc. | Subpotent Drug: Out of Specification results for Assay |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| January 15, 2020 | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical 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. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the cyanocobalamin label say about other medicines?
The cyanocobalamin label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 10 other medicines name cyanocobalamin. 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 | drug interactions | DRUG INTERACTIONS Chloramphenicol may decrease the efficacy of NASCOBAL when used for treatment of anemia. |
| Hydroxocobalamin | warnings and precautions | For patients with Leber’s disease requiring vitamin B 12 , consider alternative therapy (e.g., hydroxocobalamin) for B 12 supplementation. |
Source: FDA drug label (Cyanocobalamin), American Regent, Inc., effective October 31, 2023 (SPL set 2fb653d6-e2b2-4969-831b-c0dc37b9c0cc), via openFDA; the full label on DailyMed
What do FAERS reports show for cyanocobalamin?
The FDA Adverse Event Reporting System holds 32,744 reports that list cyanocobalamin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3,282 are coded as a death and 13,233 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 vitamin b12s
- the pharmacologic class, with prices and generics
- Cyanocobalamin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other