Prescription medicine
Trypan blue Brand names: Membraneblue, Visionblue
Trypan blue (Membraneblue) is a prescription medicine with an FDA approval on record since 2004. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the trypan blue FDA label on DailyMed (effective April 17, 2026, D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.); the NDA 21670 record on Drugs@FDA; every trypan blue 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 usageVisionBlue® 0.06% is indicated for use as an aid in ophthalmic surgery by staining the anterior capsule of the lens.
Forms and strengths
- 0.3 mg/.5ml
- 0.75 mg/.5ml
Injection (solution).
On the market
- Earliest approval on file
- December 16, 2004 Visionblue, Dorc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 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; 1 more by firms not listed as its makers
- FAERS reports
- 46 through July 30, 2026
What is trypan blue used for?
From the label: indications and usageVisionBlue® 0.06% is indicated for use as an aid in ophthalmic surgery by staining the anterior capsule of the lens. VisionBlue® 0.06% is a diagnostic dye indicated for use as an aid in ophthalmic surgery by staining the anterior capsule of the lens.
FDA pharmacologic class: Diagnostic Dye.
Source: FDA drug label (VISIONBLUE), NDA021670 (Dorc), as published by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V., effective April 17, 2026 (SPL set a44bc2ef-3d7f-4125-a7f7-c5969b1b4142), via openFDA; the full label on DailyMed
Is there a generic for trypan blue (Membraneblue)?
No generic trypan blue is approved (Drugs@FDA, October 8, 2026).
- 2004 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has trypan blue been recalled?
The FDA's Enforcement Report lists 1 recall naming trypan blue since 2012: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of trypan blue and that holds 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 |
|---|---|---|---|
| May 21, 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. … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for trypan blue?
The FDA Adverse Event Reporting System holds 46 reports that list trypan blue among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 1 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?
- Other diagnostic dyes
- the pharmacologic class, with prices and generics
- Trypan blue side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other