Class II · Moderate risk
BioGlo Fluorescein Sodium Ophthalmic Strips USP
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Is Fluorescein recalled?
Yes — there is an active recall. 8 ongoing FDA recalls mention Fluorescein (18 total). Check the affected lots below.
Most common reason: Sterility / contamination (9 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Fluorescein. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Fluorescein recalls on record
none so far in 2026; 18 on record, newest first
Class II · Moderate risk
Bio Glo Fluorescein Sodium Ophthalmic Strips USP
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk
CHNaO Fluorescein Sodium Ophthalmic Strips
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class III · Low risk
Fluorescein 2% Ophth
Subpotent Drug
Class II · Moderate risk
Ful-Glo
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.
Class II · Moderate risk
Ful-Glo
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.
Class II · Moderate risk
GloStrips
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.
Class II · Moderate risk
GloStrips
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.
Class III · Low risk
Dry Eye Test
Subpotent Drug
Class II · Moderate risk
Fluorescein
Lack of Assurance of Sterility
Class II · Moderate risk
OCuSOFT Flucaine Proparacaine Hydrochloride and Fluorescein Sodium Ophthalmic Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Altaire Fluorescein Sodium with Proparacaine Hydrochloride Ophthalmic Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Fluorescein Sodium
Lack of Assurance of Sterility.
Class II · Moderate risk
Fluorescein/Indocyanine
Lack of Assurance of Sterility
Class III · Low risk
Fluorescein Sodium Ophthalmic Strips USP
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.
Class III · Low risk
Fluorescein Sodium Ophthalmic Strips USP
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.
Class II · Moderate risk
Fluorescein Sodium active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Fluorescein/Indocyanine
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 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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