Naphazoline recalls

The FDA has published 5 recalls involving Naphazoline since 2022. The latest was reported on 29 Jul 2026. Most were for sterility. Rohto-Mentholatum (Vietnam) 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 recalls5since 2022

Last 12 months4reported

Class I00% of total

Ongoing4latest 29 Jul 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 4Jul 0 0

Severity split

Class I 0 0%Class II 5 100%Class III 0 0%

Why naphazoline is recalled

Sterility480%
Manufacturing (CGMP) Deviations120%

Companies

Brands

By year

2026480%
2022120%

Ongoing naphazoline recalls

4 active

Reported	Class	Recall	Company	Reason	Where
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 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

All naphazoline recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
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 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
17 Aug 2022Drug	CLASS II	Naphcon A eye drops, Naphazoline HCl recalledNaphcon A	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide

Should you stop taking Naphazoline?

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.