Eye Drops recalls

The FDA has published 606 recalls involving eye drops since 2012. The latest was reported on 14 Oct 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 recalls606since 2012

Last 12 months47reported

Class I285% of total

Ongoing180latest 14 Oct 2026

Recalls per month, last 24 months

click a bar for that month

3Dec '24 4 1 1Mar 0 5 1Jun 2 1 0Sep 2 1 0Dec 0 0 7Mar 5 5 1Jun 10 1 11Sep 6 0

Severity split

Class I 28 5%Class II 496 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 Office152%
Kilitch Healthcare India142%
Amman Pharmaceutical Industries142%
Medtech Products142%
K.C. Pharmaceuticals132%

Brands

Timolol Maleate102%
Cequa41%
Glostrips41%
Carboxymethylcellulose Sodium41%
Moxifloxacin30%
Lubricant Drops30%
Cystaran30%
Brimonidine Tartrate/timolol Maleate Ophthalmic Solution30%

By year

2026468%
2025183%
2024478%
20238714%
2022468%
2021193%
2020183%
201914524%
2018102%
2017193%

Ongoing eye drops recalls

180 active

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Drug	CLASS II	Sterile Eye Drops Redness Relief (Glycerin recalledLeader Eye Drops Redness Relief	K.C. Pharmaceuticals	Sterility	Nationwide
14 Oct 2026Drug	CLASS II	Sterile EYE Drops AC (tetrahydrozoline HCl recalledGoodsense Eye Drops Irritation Relief	K.C. Pharmaceuticals	Sterility	Nationwide
14 Oct 2026Drug	CLASS II	Artificial Tears Sterile Lubricant Eye Drops recalledLeader Artificial Tears 15 Ml	K.C. Pharmaceuticals	Sterility	Nationwide
14 Oct 2026Drug	CLASS II	Eye Drops Maximum, Redness Relief, Sterile recalledTarget Eye Drops Maximum Redness Relief Eye	K.C. Pharmaceuticals	Sterility	Nationwide
14 Oct 2026Drug	CLASS II	Sterile Eye Drops, Original recalled by K.C. PharmaceuticalsGoodsense Eye Drops Original Formula	K.C. Pharmaceuticals	Sterility	Nationwide
14 Oct 2026Drug	CLASS II	Sterile Lubricant Dry Eye Relief Eye Drops recalledLeader Dry Eye Relief Eye Drops	K.C. Pharmaceuticals	Sterility	Nationwide

All eye drops recalls, newest first

606 total

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Drug	CLASS II	Sterile Eye Drops Redness Relief (Glycerin recalledLeader Eye Drops Redness Relief	K.C. Pharmaceuticals	Sterility	Nationwide
14 Oct 2026Drug	CLASS II	Sterile EYE Drops AC (tetrahydrozoline HCl recalledGoodsense Eye Drops Irritation Relief	K.C. Pharmaceuticals	Sterility	Nationwide
14 Oct 2026Drug	CLASS II	Artificial Tears Sterile Lubricant Eye Drops recalledLeader Artificial Tears 15 Ml	K.C. Pharmaceuticals	Sterility	Nationwide
14 Oct 2026Drug	CLASS II	Eye Drops Maximum, Redness Relief, Sterile recalledTarget Eye Drops Maximum Redness Relief Eye	K.C. Pharmaceuticals	Sterility	Nationwide
14 Oct 2026Drug	CLASS II	Sterile Eye Drops, Original recalled by K.C. PharmaceuticalsGoodsense Eye Drops Original Formula	K.C. Pharmaceuticals	Sterility	Nationwide
14 Oct 2026Drug	CLASS II	Sterile Lubricant Dry Eye Relief Eye Drops recalledLeader Dry Eye Relief Eye Drops	K.C. Pharmaceuticals	Sterility	Nationwide
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 recalled	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 recalled	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

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.