Eye Drops recalls

The FDA has published 600 recalls involving eye drops since 2012. The latest was reported on 30 Sep 2026. Most were for sterility. Altaire Pharmaceuticals has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls600since 2012

Last 12 months42reported

Class I285% of total

Ongoing174latest 30 Sep 2026

Recalls per month, last 24 months

click a bar for that month

1Nov '24 3 4 1Feb 1 0 5May 1 2 1Aug 0 2 1Nov 0 0 0Feb 7 5 5May 1 10 1Aug 11 0

Severity split

Class I 28 5%Class II 490 82%Class III 82 14%

Why eye drops is recalled

Companies

Altaire Pharmaceuticals7813%
Akorn6411%
Franck's Lab Inc., d.b.a. Franck's Compounding Lab386%
Mckesson Medical-Surgical Inc. Corporate Office153%
Kilitch Healthcare India142%
Medtech Products142%
Amman Pharmaceutical Industries142%
Martin Avenue Pharmacy132%

Brands

By year

2026407%
2025183%
2024478%
20238715%
2022468%
2021193%
2020183%
201914524%
2018102%
2017193%

Ongoing eye drops recalls

174 active

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Drug	CLASS II	Reliable-1 Laboratories Lubricating Tears, Sterile recalledLubricating Tears	Sterling Pharmaceutical Services	Sterility	Nationwide
30 Sep 2026Drug	CLASS II	Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye recalled	Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare	Sterility	Nationwide
30 Sep 2026Drug	CLASS II	Walgreens Lubricant Eye Drops recalled by Sterling PharmaceuticalWalgreens Lubricant Eye Drops	Sterling Pharmaceutical Services	Sterility	Nationwide
30 Sep 2026Drug	CLASS II	Walgreens Lubricant Eye Drops Total Twin Pack recalledWalgreens Lubricant Eye Drops	Sterling Pharmaceutical Services	Sterility	Nationwide
30 Sep 2026Drug	CLASS II	Reliable -1 Laboratories, Sodium Chloride Hypertonicity recalledSodium Chloride Hypertonicity Ophthalmic Solution, 5%	Sterling Pharmaceutical Services	Sterility	Nationwide
30 Sep 2026Drug	CLASS II	Lubricant Eye Drops-Cameron Pharmaceuticals recalled	Sterling Pharmaceutical Services	Sterility	Nationwide

All eye drops recalls, newest first

600 total

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Drug	CLASS II	Reliable-1 Laboratories Lubricating Tears, Sterile recalledLubricating Tears	Sterling Pharmaceutical Services	Sterility	Nationwide
30 Sep 2026Drug	CLASS II	Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye recalled	Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare	Sterility	Nationwide
30 Sep 2026Drug	CLASS II	Walgreens Lubricant Eye Drops recalled by Sterling PharmaceuticalWalgreens Lubricant Eye Drops	Sterling Pharmaceutical Services	Sterility	Nationwide
30 Sep 2026Drug	CLASS II	Walgreens Lubricant Eye Drops Total Twin Pack recalledWalgreens Lubricant Eye Drops	Sterling Pharmaceutical Services	Sterility	Nationwide
30 Sep 2026Drug	CLASS II	Reliable -1 Laboratories, Sodium Chloride Hypertonicity recalledSodium Chloride Hypertonicity Ophthalmic Solution, 5%	Sterling Pharmaceutical Services	Sterility	Nationwide
30 Sep 2026Drug	CLASS II	Lubricant Eye Drops-Cameron Pharmaceuticals recalled	Sterling Pharmaceutical Services	Sterility	Nationwide
30 Sep 2026Drug	CLASS II	AvKare Carboxymethylcellulose Sodium Ophthalmic Solution recalledCarboxymethylcellulose Sodium	Sterling Pharmaceutical Services	Sterility	Nationwide
30 Sep 2026Drug	CLASS II	Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye recalled	Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare	Sterility	Nationwide
30 Sep 2026Drug	CLASS II	AvKare Carboxymethylcellulose Sodium Ophthalmic Solution recalledCarboxymethylcellulose Sodium	Sterling Pharmaceutical Services	Sterility	Nationwide
30 Sep 2026Drug	CLASS II	TRP The Relief Products* Gentle Eyes Lubricant Eye Drops recalledGentle Eyes Lubricant Eye Drops	Sterling Pharmaceutical Services	Sterility	Nationwide
16 Sep 2026Drug	CLASS III	Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic recalled	ImprimisRx NJ	Potency & Assay	Nationwide
5 Aug 2026Drug	CLASS II	Dorzolamide HCl and Timolol Maleate Ophthalmic Solution recalledDorzolamide Hydrochloride And Timolol Maleate Ophthalmic Solution	Micro Labs USA	Other	Nationwide
29 Jul 2026Drug	CLASS II	Rohto Cooling Eye Drops Dry Aid (povidone recalledRohto Dry-aid	Rohto-Mentholatum (Vietnam)	Sterility	Nationwide
29 Jul 2026Drug	CLASS II	Rohto Cooling Eye Drops All-in-one (hypromellose recalledRohto	Rohto-Mentholatum (Vietnam)	Sterility	Nationwide
29 Jul 2026Drug	CLASS II	Rohto Cooling Eye Drops Optic Glow recalledRohto Optic Glow	Rohto-Mentholatum (Vietnam)	Sterility	Nationwide
29 Jul 2026Drug	CLASS II	Rohto Cooling Eye Drops Max Strength recalledRohto	Rohto-Mentholatum (Vietnam)	Sterility	Nationwide
29 Jul 2026Drug	CLASS II	Rohto Cooling Eye Drops Dry Aid (povidone recalledRohto Dry-aid	Rohto-Mentholatum (Vietnam)	Sterility	Nationwide
29 Jul 2026Drug	CLASS II	Rohto Cooling Eye Drops Digi Eye (hypromellose recalledRohto Digi-eye	Rohto-Mentholatum (Vietnam)	Sterility	Nationwide
29 Jul 2026Drug	CLASS II	Rohto Cooling Eye Drops Cool Relief recalledRohto	Rohto-Mentholatum (Vietnam)	Sterility	Nationwide
29 Jul 2026Drug	CLASS II	Rohto Cooling Eye Drops Max Strength recalledRohto	Rohto-Mentholatum (Vietnam)	Sterility	Nationwide
8 Jul 2026Drug	CLASS II	prednisoLONE Acetate Ophthalmic Suspension recalledPrednisolone Acetate	Lupin Pharmaceuticals	Other	Nationwide
1 Jul 2026Drug	CLASS II	Vitamin See Antioxidant Preservative Free Eye Drops recalled by PReye	PReye	Sterility	CO
3 Jun 2026Drug	CLASS III	Pred Mild, prednisolone acetate ophthalmic suspension recalled by AbbViePred Mild	AbbVie	Potency & Assay	Nationwide
20 May 2026Drug	CLASS II	Oasis Tears PF, Preservative-Free Lubricant Eye Drops/, Sterile recalledOasis Tears Pf	Oasis Medical	Sterility	Nationwide
6 May 2026Drug	CLASS II	Systane, Lubricant Eye Gel, Night Gel, Sterile, Processed recalledSystane	Alcon Research	Sterility	Nationwide
6 May 2026Drug	CLASS II	GenTeal Tears, Lubricant Eye Gel, Sterile recalled by Alcon ResearchGenteal Tears	Alcon Research	Sterility	Nationwide
6 May 2026Drug	CLASS II	iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%) recalledIvizia Dry Eye	Thea Pharma	Sterility	Nationwide
6 May 2026Drug	CLASS II	Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%) recalled	Thea Pharma	Sterility	Nationwide
29 Apr 2026Drug	CLASS II	Freshkote Lubricant Eyedrops, Sterile, Harrow Eye Llc recalled	Harrow Eye	Sterility	Nationwide
8 Apr 2026Drug	CLASS II	Sterile EYE Drops AC (tetrahydrozoline HCl recalledQuality Choice Eye Drops Irritation Relief	K.C. Pharmaceuticals	Sterility	Nationwide

Should you stop taking Eye Drops?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.