Prescription medicine
Brilliant blue g Brand names: Tissueblue
Brilliant blue g (Tissueblue) is a prescription medicine with an FDA approval on record since 2019. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the brilliant blue g FDA label on DailyMed (effective April 17, 2026, D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.); the NDA 209569 record on Drugs@FDA; every brilliant blue g label on DailyMed.
Highlights of the record
FDA label of April 17, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageTissueBlue 0.025% is indicated to selectively stain the internal limiting membrane (ILM).
Forms and strengths
- 0.0125 mg/.5ml
Injection (solution).
On the market
- Earliest approval on file
- December 20, 2019 Tissueblue, Dutch Ophthalmic; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 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)
- 0 since 2012 0 Class I among all firms' recalls; 3 more by firms not listed as its makers
- FAERS reports
- 21 through July 30, 2026
What is brilliant blue g used for?
From the label: indications and usageTissueBlue 0.025% is indicated to selectively stain the internal limiting membrane (ILM). TissueBlue 0.025% is a disclosing agent indicated to selectively stain the internal limiting membrane (ILM).
FDA pharmacologic class: Disclosing Agent.
Source: FDA drug label (TISSUEBLUE), D.O.R.C. Dutch Ophthalmic Research Center (International) B.V., effective April 17, 2026 (SPL set 9d4b28b4-c582-4e2c-abd9-f7e203378e2d), via openFDA; the full label on DailyMed
Is there a generic for brilliant blue g (Tissueblue)?
No generic brilliant blue g is approved (Drugs@FDA, October 8, 2026).
- 2019 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has brilliant blue g been recalled?
The FDA's Enforcement Report lists 3 recalls naming brilliant blue g since 2012: 0 Class I (the most serious), 3 Class II, 0 Class III; 1 still ongoing. 3 of them are by firms that FDA's NDC Directory does not list as a maker of brilliant blue g 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 |
|---|---|---|---|
| October 7, 2022 | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder not a listed maker | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products … |
| July 26, 2016 | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder not a listed maker | Lack of Assurance of Sterility |
| May 25, 2012 | Class II | Franck's Lab Inc., d.b.a. Franck's Compounding Lab not a listed maker | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for brilliant blue g?
The FDA Adverse Event Reporting System holds 21 reports that list brilliant blue g among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 0 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Brilliant blue g side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other