Eye Drops recalls

The FDA has published 590 recalls involving eye drops since 2012. The latest was reported on 5 Aug 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 recalls590since 2012

Last 12 months32reported

Class I285% of total

Ongoing164latest 5 Aug 2026

Recalls per month, last 24 months

click a bar for that month

4Oct '24 1 3 4Jan '25 1 1 0Apr 5 1 2Jul 1 0 2Oct 1 0 0Jan '26 0 7 5Apr 5 1 10Jul 1 0

Severity split

Class I 28 5%Class II 480 81%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%
Medtech Products142%
Amman Pharmaceutical Industries142%
Kilitch Healthcare India142%
Edge Pharma132%

Brands

Timolol Maleate102%
Moxifloxacin51%
Cequa41%
Rohto41%
Glostrips41%
Brimonidine Tartrate41%
Lubricant Drops31%
Brimonidine Tartrate/timolol Maleate Ophthalmic Solution31%

By year

2026295%
2025183%
2024478%
20238815%
2022468%
2021193%
2020183%
201914525%
2018102%
2017193%

Ongoing eye drops recalls

164 active

Reported	Class	Recall	Company	Reason	Where
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) Co	Sterility	Nationwide
29 Jul 2026Drug	CLASS II	Rohto Cooling Eye Drops All-in-one (hypromellose recalledRohto	Rohto-Mentholatum (Vietnam) Co	Sterility	Nationwide
29 Jul 2026Drug	CLASS II	Rohto Cooling Eye Drops Optic Glow recalledRohto Optic Glow	Rohto-Mentholatum (Vietnam) Co	Sterility	Nationwide
29 Jul 2026Drug	CLASS II	Rohto Cooling Eye Drops Max Strength recalledRohto	Rohto-Mentholatum (Vietnam) Co	Sterility	Nationwide
29 Jul 2026Drug	CLASS II	Rohto Cooling Eye Drops Dry Aid (povidone recalledRohto Dry-aid	Rohto-Mentholatum (Vietnam) Co	Sterility	Nationwide

All eye drops recalls, newest first

590 total

Reported	Class	Recall	Company	Reason	Where
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) Co	Sterility	Nationwide
29 Jul 2026Drug	CLASS II	Rohto Cooling Eye Drops All-in-one (hypromellose recalledRohto	Rohto-Mentholatum (Vietnam) Co	Sterility	Nationwide
29 Jul 2026Drug	CLASS II	Rohto Cooling Eye Drops Optic Glow recalledRohto Optic Glow	Rohto-Mentholatum (Vietnam) Co	Sterility	Nationwide
29 Jul 2026Drug	CLASS II	Rohto Cooling Eye Drops Max Strength recalledRohto	Rohto-Mentholatum (Vietnam) Co	Sterility	Nationwide
29 Jul 2026Drug	CLASS II	Rohto Cooling Eye Drops Dry Aid (povidone recalledRohto Dry-aid	Rohto-Mentholatum (Vietnam) Co	Sterility	Nationwide
29 Jul 2026Drug	CLASS II	Rohto Cooling Eye Drops Digi Eye (hypromellose recalledRohto Digi-eye	Rohto-Mentholatum (Vietnam) Co	Sterility	Nationwide
29 Jul 2026Drug	CLASS II	Rohto Cooling Eye Drops Cool Relief recalledRohto	Rohto-Mentholatum (Vietnam) Co	Sterility	Nationwide
29 Jul 2026Drug	CLASS II	Rohto Cooling Eye Drops Max Strength recalledRohto	Rohto-Mentholatum (Vietnam) Co	Sterility	Nationwide
8 Jul 2026Drug	CLASS II	prednisoLONE Acetate Ophthalmic Suspension recalledPrednisolone Acetate	Lupin 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.