Diagnostic Dye
Where is Fluorescein made?
11 companies sell it under their own name and 2 repackagers rebottle it. Their labels name 8 factories in India and the United States.
India 5United States 3
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| HUB Pharmaceuticals, Inc.1 mg per 1 mg · NDC 17238-900 | Madhu Instruments Private LimitedMakes it | New Deli, India | Serious problems, FDA actionOct 2022 |
| Omni Lens Private LimitedMakes it | Ahmedabad, India | Not inspected on record | |
| Vistamerica USA1 mg per 1 mg · NDC 83851-100 | Madhu Instruments Private LimitedMakes it | New Deli, India | Serious problems, FDA actionOct 2022 |
| Wizcure Pharmaa Private LimitedMakes it | Alwar, India | Serious problems, FDA actionDec 2025 | |
| Zydus Pharmaceuticals (USA) Inc.100 mg per 1 mL, 250 mg per 1 mL · NDC 70710-2045, 70710-2046 | Anthea Pharma Private LimitedMakes it, tests it, packages it and labels it | Sangareddy, India | Not inspected on record |
| Zydus Lifesciences LimitedMakes it and tests it | Vadodara, India | Serious problems, FDA actionApr 2024 | |
| Akorn Ak-Fluor0.6 mg, 1 mg, 100 mg per 1 mL, 250 mg per 1 mL · NDC 17478-403, 17478-404, 17478-253 +1 | AkornMakes it, tests it and sterilizes it | Location not on file | Not inspected on record |
| Alcon Laboratories, Inc. Fluorescite100 mg per 1 mL · NDC 0065-0092 | Alcon Research LLCMakes it | Fort Worth, TX, United States | No problems foundSep 2022 |
| Anthea Pharma Private Limited100 mg per 1 mL · NDC 83854-048 | Anthea Pharma Private LimitedMakes it, tests it, packages it and labels it | Sangareddy, India | Not inspected on record |
| BPI Labs, LLC500 mg per 5 mL · NDC 54288-179 | BPI Labs LLCMakes it and tests it | Largo, FL, United States | Problems found, fixed voluntarilyApr 2025 |
| Cadila Healthcare Limited100 mg per 1 mL, 250 mg per 1 mL · NDC 70771-1969, 70771-1970 | Zydus Lifesciences LimitedMakes it and tests it | Vadodara, India | Serious problems, FDA actionApr 2024 |
| Nomax Inc.0.12 mg, 0.6 mg, 1 mg · NDC 51801-008, 51801-003, 51801-009 | Nomax, INCMakes it | Saint Louis, MO, United States | Problems found, fixed voluntarilyDec 2022 |
| Long Grove Pharmaceuticals, LLC Ak-Fluor100 mg per 1 mL · NDC 81298-8660 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Nexus Pharamaceuticals Inc.250 mg per 1 mL, 500 mg per 1 mL · NDC 14789-123, 14789-122 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Fluorescein in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- A-S Medication Solutions:
50090-4535 - HF Acquisition Co. LLC. DBA HealthFirst:
51662-1533
Recalls
- Dec 31, 2025 · Class II · Wizcure Pharmaa Private Limited · 3 recall notices
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. - Apr 19, 2024 · Class II · Nomax Inc · 4 recall notices
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities. - Apr 13, 2021 · Class III · Nomax Inc
Subpotent Drug - Mar 24, 2015 · Class III · Nomax Inc · 2 recall notices
Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of flu…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.