Eye drop and ophthalmic recalls
106 FDA-recorded recalls of eye drop and ophthalmics, most recent Sep 2026 — newest first, straight from the FDA's own database.
The largest recent eye-product recalls were for LOSS OF STERILITY — sterile eye drops and artificial tears contaminated during manufacture, most seriously the 2023 outbreak tied to drug-resistant bacteria that caused infections, vision loss and deaths. Sterility matters more for the eye than for the gut: a contaminant is placed directly on the eye. If a product you use is recalled for a sterility or contamination reason, stop using it and follow the FDA notice.
Clear Eyes Redness Relief
Class IILack of Assurance of Sterility
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company · Sep 30, 2026
Clear Eyes Redness Relief
Class IILack of Assurance of Sterility
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company · Sep 30, 2026
Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution
Class IIISubpotent Drug
ImprimisRx NJ LLC · Sep 16, 2026
TRP The Relief Products* Gentle Eyes Lubricant Eye Drops
Class IILack of Assurance of Sterility
Sterling Pharmaceutical Services LLC · Sep 30, 2026
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%
Class IILack of Assurance of Sterility
Sterling Pharmaceutical Services LLC · Sep 30, 2026
Lubricant Eye Drops-Cameron Pharmaceuticals
Class IILack of Assurance of Sterility
Sterling Pharmaceutical Services LLC · Sep 30, 2026
Reliable -1 Laboratories
Class IILack of Assurance of Sterility
Sterling Pharmaceutical Services LLC · Sep 30, 2026
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%
Class IILack of Assurance of Sterility
Sterling Pharmaceutical Services LLC · Sep 30, 2026
Walgreens Lubricant Eye Drops
Class IILack of Assurance of Sterility
Sterling Pharmaceutical Services LLC · Sep 30, 2026
Walgreens Lubricant Eye Drops
Class IILack of Assurance of Sterility
Sterling Pharmaceutical Services LLC · Sep 30, 2026
Dorzolamide HCl and Timolol Maleate Ophthalmic Solution
Class IIDefective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
MICRO LABS USA INC · Aug 5, 2026
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%
Class IILack of Assurance of Sterility
Rohto-Mentholatum (Vietnam) Co., Ltd. · Jul 29, 2026
Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%
Class IILack of Assurance of Sterility
Rohto-Mentholatum (Vietnam) Co., Ltd. · Jul 29, 2026
Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%
Class IILack of Assurance of Sterility
Rohto-Mentholatum (Vietnam) Co., Ltd. · Jul 29, 2026
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%
Class IILack of Assurance of Sterility
Rohto-Mentholatum (Vietnam) Co., Ltd. · Jul 29, 2026
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%
Class IILack of Assurance of Sterility
Rohto-Mentholatum (Vietnam) Co., Ltd. · Jul 29, 2026
Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%
Class IILack of Assurance of Sterility
Rohto-Mentholatum (Vietnam) Co., Ltd. · Jul 29, 2026
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%
Class IILack of Assurance of Sterility
Rohto-Mentholatum (Vietnam) Co., Ltd. · Jul 29, 2026
Rohto Cooling Eye Drops Digi (hypromellose 0.35%
Class IILack of Assurance of Sterility
Rohto-Mentholatum (Vietnam) Co., Ltd. · Jul 29, 2026
prednisoLONE Acetate Ophthalmic Suspension
Class IIPresence of Foreign Substance
Lupin Pharmaceuticals Inc. · Jul 8, 2026
PReye Vitamin See Antioxidant Preservative Free Eye Drops
Class IILack of Assurance of Sterility
PReye LLC · Jul 1, 2026
PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL…
Class IIIFailed Stability Specifications
AbbVie Inc. · Jun 3, 2026
Oasis Tears PF
Class IILack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.
Oasis Medical, Inc. · May 20, 2026
iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made…
Class IILack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Thea Pharma, Inc. · May 6, 2026
Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10…
Class IILack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Thea Pharma, Inc. · May 6, 2026
GenTeal Tears
Class IILack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Alcon Research LLC · May 6, 2026
Systane, Lubricant Eye Gel, Night Sterile, 10g (0.35 oz), Processed in France…
Class IILack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Alcon Research LLC · May 6, 2026
FRESHKOTE LUBRICANT EYEDROPS
Class IILack of Assurance of Sterility
Harrow Eye LLC · Apr 29, 2026
Artificial Tears Lubricant Eye Drops (glycerin 0.2%
Class IILack of Assurance of Sterility
Preferred Pharmaceuticals, Inc. · Apr 15, 2026
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*
Class IILack of Assurance of Sterility
Apotex Corp. · Mar 25, 2026
Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%
Class IILack of Assurance of Sterility
K.C. Pharmaceuticals, Inc · Apr 8, 2026
Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%)
Class IILack of Assurance of Sterility
K.C. Pharmaceuticals, Inc · Apr 8, 2026
Sterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline HCl 0.012%)
Class IILack of Assurance of Sterility
K.C. Pharmaceuticals, Inc · Apr 8, 2026
Ultra Lubricating Eye Drops (polyethylene 400 0.4%
Class IILack of Assurance of Sterility
K.C. Pharmaceuticals, Inc · Apr 8, 2026
EYE DROPS Advanced Relief
Class IILack of Assurance of Sterility
K.C. Pharmaceuticals, Inc · Apr 8, 2026
STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene…
Class IILack of Assurance of Sterility
K.C. Pharmaceuticals, Inc · Apr 8, 2026
Dry Eye Relief Drops
Class IILack of Assurance of Sterility
K.C. Pharmaceuticals, Inc · Apr 8, 2026
Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%
Class IILack of Assurance of Sterility
K.C. Pharmaceuticals, Inc · Apr 8, 2026
Bio Glo Fluorescein Sodium Ophthalmic Strips USP
Class IILack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Wizcure Pharmaa Private Limited · Mar 4, 2026
CHNaO Fluorescein Sodium Ophthalmic Strips
Class IILack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Wizcure Pharmaa Private Limited · Mar 4, 2026
Vista Gonio Eye Lubricant
Class IILack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Wizcure Pharmaa Private Limited · Mar 4, 2026
Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Relief…
Class IILack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Wizcure Pharmaa Private Limited · Mar 4, 2026
Vista Tears Polyethylene Glycol 400 0.4% w/v
Class IILack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Wizcure Pharmaa Private Limited · Mar 4, 2026
BioGlo Fluorescein Sodium Ophthalmic Strips USP
Class IILack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Wizcure Pharmaa Private Limited · Mar 4, 2026
Vista Gel Hypromellose USP 0.3% w/v
Class IILack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Wizcure Pharmaa Private Limited · Mar 4, 2026
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical…
Class IIIncorrect Product Formulation
Fagron Compounding Services · Dec 17, 2025
Klarity-C Drops (Cyclosporine) 0.1%
Class IIISubpotent Drug
Imprimis NJOF, LLC · Nov 26, 2025
Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %
Class IIFailed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
USV Private Limited · Oct 29, 2025
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
Class IILack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Apotex Corp. · Oct 8, 2025
Ketorolac Tromethamine Ophthalmic Solution
Class IILack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Apotex Corp. · Oct 8, 2025
Tropicamide-Proparacaine-Phenylephrine-Ketorolac
Class IIISub-Potent Drug: Subpotent assay results during stability testing.
Imprimis NJOF, LLC · Jul 30, 2025
Timolol Maleate Ophthalmic Solution USP
Class IIDefective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
FDC Limited · Aug 6, 2025
Ketorolac Tromethamine Ophthalmic Solution
Class IILack of Assurance of Sterility
Apotex Corp. · Jul 2, 2025
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
Class IILack of Assurance of Sterility
Apotex Corp. · Jul 2, 2025
Azelastine HCl Ophthalmic Solution
Class IILack of Assurance of Sterility
Apotex Corp. · Jul 2, 2025
Bromfenac Ophthalmic Solution 0.09%
Class IIFailed Impurities/Degradation Specifications
Alembic Pharmaceuticals Limited · Jun 4, 2025
Polyvinyl Alcohol Ophthalmic Solution 1.4%
Class IIcGMP deviations and lack of assurance of sterility.
BRS Analytical Services, LLC · May 14, 2025
Carboxymethylcellulose Sodium Ophthalmic Gel 1%
Class IIcGMP deviations and lack of assurance of sterility.
BRS Analytical Services, LLC · May 14, 2025
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%
Class IIcGMP deviations and lack of assurance of sterility.
BRS Analytical Services, LLC · May 14, 2025
Lubricant Eye Drops Solution
Class IIcGMP deviations and lack of assurance of sterility.
BRS Analytical Services, LLC · May 14, 2025
How to use this page
A drug appearing here does not mean your prescription is unsafe. Recalls name specific lots and manufacturers — open the recall to see the affected lot numbers, and match them against your bottle. Never stop a blood-pressure, cholesterol, diabetes, antidepressant or antibiotic medicine on your own because of a recall; confirm your lot, then ask your pharmacist for a replacement if it is affected.
Other categories: Blood pressure medication · Cholesterol medication · Diabetes medication · Antidepressant · Antibiotic · Thyroid medication · Allergy and antihistamine · Hormonal and contraceptive · ADHD and stimulant medication · Opioid and pain medication · Seizure and epilepsy medication · Asthma and inhaler · Heartburn and acid-reflux medication. See also the full recalls tracker and the recall report.
Source: the openFDA drug Enforcement (recall) database. Recalls are matched to this category by the drug names in the FDA’s product description; a small number of category recalls may be missed if the description omits the ingredient. Figures are recall events, not units, and reflect our copy of the FDA data, refreshed daily. This is public regulatory data, not medical advice.