Prescription medicine
Oxygen Brand names: Air, Oxygen-Nitrogen, Oxygen-Helium, Reconstituted, Medical
Oxygen (Air) is a prescription medicine with an FDA approval on record since 2013. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the oxygen FDA label on DailyMed (effective June 15, 2026, Airgas USA, LLC); the NDA 205712 record on Drugs@FDA; every oxygen label on DailyMed.
Highlights of the record
FDA label of June 15, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
The label in openFDA carries no indications section.
Forms and strengths
- 50 ml
- 200 ml
- 210 ml
- 235 ml
- 250 ml
- 300 ml
- 400 ml
- 500 ml
- 800 ml
- 900 ml
- 950 ml
- 990 ml
Gas; liquid.
On the market
- Earliest approval on file
- June 16, 2013 Oxygen, Usp, Air Liquid Industrial Us Lp; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 207 of which 0 under generic applications, 207 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)
- 6 since 2012 0 Class I among all firms' recalls; latest November 9, 2023; 2 more by firms not listed as its makers
- FAERS reports
- 48,974 through July 30, 2026
Is there a generic for oxygen (Air)?
No generic oxygen is approved (Drugs@FDA, October 8, 2026).
- 2013 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has oxygen been recalled?
The FDA's Enforcement Report lists 8 recalls naming oxygen since 2012: 0 Class I (the most serious), 7 Class II, 1 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of oxygen 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 |
|---|---|---|---|
| November 9, 2023 | Class II | Family Medical Supply Inc | cGMP Deviations |
| April 15, 2021 | Class II | Grace Healthcare Medical, Inc not a listed maker | cGMP deviations |
| December 19, 2018 | Class II | Roberts Home Medical LLC | CGMP Deviations |
| February 5, 2016 | Class III | Medical Park Homecare, Inc not a listed maker | CGMP Deviations: Cylinders filled using out of date gauges. |
| November 29, 2015 | Class II | AGA Gas Inc | cGMP Deviations; trailer may not have met GMP requirements prior to filling |
| October 10, 2013 | Class II | Airgas Medical Services | Short Fill: Due to an error in the manufacturing process, cylinders in this lot may be empty and contain no medical oxygen. |
| December 5, 2012 | Class II | Oklahoma Respiratory Care Inc | Failed impurities/degradation specifications: Purity readings for oxygen were out of specification. |
| June 21, 2012 | Class II | Oklahoma Respiratory Care Inc | CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for oxygen?
The FDA Adverse Event Reporting System holds 48,974 reports that list oxygen among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 7,162 are coded as a death and 20,919 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?
- Oxygen side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other