Prescription medicine
Pyridoxine
Pyridoxine is a prescription medicine. FDA's NDC Directory lists it from 2 generic labelers.
- Generic listed
Check it at the source: the pyridoxine FDA label on DailyMed (effective October 15, 2024, Fresenius Kabi USA, LLC); every pyridoxine label on DailyMed.
Highlights of the record
FDA label of October 15, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usagePyridoxine Hydrochloride Injection is effective for the treatment of pyridoxine deficiency as seen in the following: Inadequate dietary intake.
Forms and strengths
- 100 mg/ml
Injection (solution).
On the market
- Generic approvals
- 7 first August 14, 1972; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 2 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2012 0 Class I among all firms' recalls; latest January 15, 2020; 27 more by firms not listed as its makers
- FAERS reports
- 2,648 through July 30, 2026
What is pyridoxine used for?
From the label: indications and usagePyridoxine Hydrochloride Injection is effective for the treatment of pyridoxine deficiency as seen in the following: Inadequate dietary intake. Drug-induced deficiency, as from isoniazid (INH) or oral contraceptives. Inborn errors of metabolism, e.g., vitamin B 6 dependent convulsions or vitamin B 6 responsive anemia. The parenteral route is indicated when oral administration is not feasible as in anorexia, nausea and vomiting, and preoperative and postoperative conditions. It is also indicated when gastrointestinal absorption is impaired.
FDA pharmacologic class: Vitamin B6 Analog.
Source: FDA drug label (Pyridoxine Hydrochloride), Fresenius Kabi USA, LLC, effective October 15, 2024 (SPL set a56d11c0-b033-4201-85ff-fc710506481a), via openFDA; the full label on DailyMed
Is there a generic for pyridoxine?
The FDA approved the first generic pyridoxine on August 14, 1972. 7 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 pyridoxine from 2 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has pyridoxine been recalled?
The FDA's Enforcement Report lists 29 recalls naming pyridoxine since 2012: 0 Class I (the most serious), 28 Class II, 1 Class III; 1 still ongoing. 27 of them are by firms that FDA's NDC Directory does not list as a maker of pyridoxine 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 |
|---|---|---|---|
| September 5, 2024 | Class II | Empower Pharmacy not a listed maker | Lack of Assurance of Sterility |
| May 9, 2022 | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy not a listed maker | Lack of assurance of sterility. |
| August 13, 2021 | Class II | First Royal Care Co. LLC, dba Red Mountain Compounding … not a listed maker | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns |
| January 15, 2020 | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical | Lack of Assurance of Sterility |
| June 19, 2019 | Class II | RXQ Compounding LLC not a listed maker | Lack of Assurance of Sterility |
| December 17, 2018 | Class II | Promise Pharmacy, LLC not a listed maker | Lack of sterility assurance. |
| September 10, 2018 | Class II | Pharm D Solutions, LLC | 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 pyridoxine label say about other medicines?
The pyridoxine label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 4 other medicines name pyridoxine. 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 |
|---|---|---|
| Carbidopa | drug interactions | However, this vitamin may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. |
| Levodopa | drug interactions | Drug Interactions Pyridoxine supplements should not be given to patients receiving levodopa, because the action of the latter drug is antagonized by pyridoxine. |
Other labels that name pyridoxine
Source: FDA drug label (Pyridoxine Hydrochloride), Fresenius Kabi USA, LLC, effective October 15, 2024 (SPL set a56d11c0-b033-4201-85ff-fc710506481a), via openFDA; the full label on DailyMed
What do FAERS reports show for pyridoxine?
The FDA Adverse Event Reporting System holds 2,648 reports that list pyridoxine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 590 are coded as a death and 1,250 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 b6 analogs
- the pharmacologic class, with prices and generics
- Pyridoxine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other