Fluorescein Sodium recalls: 5 FDA reports
Recalls involving Fluorescein Sodium. What was wrong with each batch, and how the FDA graded the risk.
5Reports
0Class I
3Ongoing
2026-03-04Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-co
D-0350-2026 · Class II · reported 2026-03-04 · Ongoing
- Why it was recalled
- Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
- Product
- CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India,
- Where it went
- Distributed Nationwide in the USA
- How much
- 10,080 boxes
GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx Only, a) 100 strips per carton, N
D-0462-2024 · Class II · reported 2024-05-01 · Ongoing
- Why it was recalled
- 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.
- Product
- GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx Only, a) 100 strips per carton, NDC 51801-003-40; b) 300 strips per carton, NDC 51801-003-50, Nomax, Inc., St. Louis, MO 63123.
- Where it went
- Nationwide in the USA
- How much
- 15,056 cartons
GloStrips, Fluorescein Sodium Ophthalmic Strips USP (1.0 mg Fluorescein), Rx Only, 100 Sterile Strips per cart
D-0463-2024 · Class II · reported 2024-05-01 · Ongoing
- Why it was recalled
- 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.
- Product
- GloStrips, Fluorescein Sodium Ophthalmic Strips USP (1.0 mg Fluorescein), Rx Only, 100 Sterile Strips per carton, Nomax, Inc., St. Louis, MO 63123, NDC 51801-009-40.
- Where it went
- Nationwide in the USA
- How much
- 6,960 cartons
Dry Eye Test, Fluorescein Sodium, Ophthalmic Strips USP (0.12mg Fluorescein Sodium), 100 Sterile Strips (50 Po
D-0387-2021 · Class III · reported 2021-05-26 · Terminated
- Why it was recalled
- Subpotent Drug
- Product
- Dry Eye Test, Fluorescein Sodium, Ophthalmic Strips USP (0.12mg Fluorescein Sodium), 100 Sterile Strips (50 Pouches of 2 Strips Each), Manufactured by: Nomax, Inc, St. Louis, MO 63123, NDC: 51801-008-15
- Where it went
- Nationwide USA
- How much
- 78 cartons
Fluorescein Sodium Ophthalmic Strips USP, 0.6 mg per strip, labeled as 1) Fluorescein GloStrips, individually
D-0961-2015 · Class III · reported 2015-04-29 · Terminated
- Why it was recalled
- 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 fluorescein present in the strips.
- Product
- Fluorescein Sodium Ophthalmic Strips USP, 0.6 mg per strip, labeled as 1) Fluorescein GloStrips, individually wrapped strip (NDC 51801-003-01), barcode (01)00351801003012, packaged in a) 100-count strips per carton (NDC 51801-003-40, UPC 3 51801 00340 1); and b) 300-count strips per carton (NDC 51801-003-50, UPC 3 51801 00350 0), Nomax, Inc., St. Louis, MO 63123 USA; and 2) FUL-GLO, individually wrapped strip (NDC 1748-403-03), barcode (01)00317478403036, packaged in 300-count strips per carton (NDC 17478-403-030, UPC 3 17478-403-03 6), Manufactured for: Akorn, Inc., Lake Forest, IL 60045.
- Where it went
- Nationwide and Puerto Rico, Australia, Brazil, Canada, Chile, Colombia, Dominican Republic, Honduras, Iceland, Israel, Jamaica, Trinidad and Tobago, and St. Lucia
- How much
- 23,201 cartons
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
← All drug recalls