Prescription medicine
Fluorescein Brand names: Ak-Fluor; first approved as Funduscein-25
Fluorescein (Ak-Fluor) is a prescription medicine with an FDA approval on record since 1976. FDA's NDC Directory lists it from 4 generic labelers.
- Generic listed
Check it at the source: the fluorescein FDA label on DailyMed (effective February 26, 2026, Long Grove Pharmaceuticals, LLC); the NDA 17869 record on Drugs@FDA; every fluorescein label on DailyMed.
Highlights of the record
FDA label of February 26, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageAK-FLUOR ® 10% (100 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.
Forms and strengths
- 100 mg/ml
- 250 mg/ml
- 500 mg/5ml
- 500 mg/ml
Injection; injection (solution).
On the market
- Earliest approval on file
- November 10, 1976 Funduscein-25, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first September 25, 2023; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 7 of which 4 under generic applications, 3 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)
- 1 since 2015 0 Class I among all firms' recalls; latest August 15, 2017; 6 more by firms not listed as its makers
- FAERS reports
- 912 through July 30, 2026
What is fluorescein used for?
From the label: indications and usageAK-FLUOR ® 10% (100 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. AK-FLUOR is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.
FDA pharmacologic class: Diagnostic Dye.
Source: FDA drug label (AK-FLUOR), Long Grove Pharmaceuticals, LLC, effective February 26, 2026 (SPL set 73511e79-c050-4dc0-aa2f-a79ed320b5b0), via openFDA; the full label on DailyMed
Is there a generic for fluorescein (Ak-Fluor)?
The FDA approved the first generic fluorescein on September 25, 2023. 3 generic applications are approved; 3 of them carry 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 fluorescein from 4 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1976 earliest approval on file
- 2023 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has fluorescein been recalled?
The FDA's Enforcement Report lists 7 recalls naming fluorescein since 2015: 0 Class I (the most serious), 5 Class II, 2 Class III; 3 still ongoing. 6 of them are by firms that FDA's NDC Directory does not list as a maker of fluorescein 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 |
|---|---|---|---|
| December 31, 2025 | Class II | Wizcure Pharmaa Private Limited not a listed maker | Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. |
| April 19, 2024 | Class II | Nomax Inc not a listed maker | Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP … |
| April 13, 2021 | Class III | Nomax Inc not a listed maker | Subpotent Drug |
| September 12, 2019 | Class II | KRS Global Biotechnology, Inc not a listed maker | Lack of Assurance of Sterility |
| August 15, 2017 | Class II | Bella Pharmaceuticals, Inc. | Lack of Assurance of Sterility. |
| March 24, 2015 | Class III | Nomax Inc not a listed maker | Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the fluorescein label say about other medicines?
The fluorescein label names no other medicine on this site. The labels of 11 other medicines name fluorescein. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name fluorescein
Source: FDA drug label (AK-FLUOR), Long Grove Pharmaceuticals, LLC, effective February 26, 2026 (SPL set 73511e79-c050-4dc0-aa2f-a79ed320b5b0), via openFDA; the full label on DailyMed
What do FAERS reports show for fluorescein?
The FDA Adverse Event Reporting System holds 912 reports that list fluorescein among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 50 are coded as a death and 240 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 diagnostic dyes
- the pharmacologic class, with prices and generics
- Fluorescein side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other