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Prescription medicine

Trypan blue

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Quick answers

What is Trypan blue used for?
The FDA-approved label (Visionblue, D.O.R.C. Dutch Ophthalmic Research Center (International) B.V., April 17, 2026) says: “VisionBlue® 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.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Trypan blue have a boxed warning?
No. None of the 2 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Trypan blue?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Trypan blue been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Trypan blue?
2 companies list prescription products of Trypan blue in the FDA NDC Directory, including D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. and Dutch Ophthalmic Research Center (International) B.V..

What Trypan blue is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

VisionBlue® 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 label: Visionblue, D.O.R.C. Dutch Ophthalmic Research Center (International) B.V., effective April 17, 2026. Read the full label on DailyMed →

The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 2 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsInjection, solution
RouteIntraocular · Ophthalmic
Prescription products2 in the FDA NDC Directory
Brand namesVisionblue, Membraneblue

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA021670
VISIONBLUE
DorcDecember 16, 2004 4, latest December 18, 2023
2023: Labeling · 2015: Manufacturing (CMC) · 2014: Manufacturing (CMC)
NDA022278
MEMBRANEBLUE
DorcFebruary 20, 2009 3, latest November 17, 2025
2025: Labeling · 2014: Labeling · 2014: Manufacturing (CMC)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

SPL set ID of the quoted labela44bc2ef-3d7f-4125-a7f7-c5969b1b4142
FDA labels (SPL)2
FDA applicationsNDA021670, NDA022278
Active ingredients (FDA)TRYPAN BLUE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Visionblue, D.O.R.C. Dutch Ophthalmic Research Center (International) B.V., effective April 17, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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