Hypromellose recalls

The FDA has published 6 recalls involving Hypromellose since 2026. 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 recalls6since 2026

Last 12 months6reported

Class I00% of total

Ongoing6latest 29 Jul 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 2 0 2May 0 2 0Aug 0 0

Severity split

Class I 0 0%Class II 6 100%Class III 0 0%

Why hypromellose is recalled

Sterility6100%

Companies

Brands

By year

20266100%

Ongoing hypromellose recalls

6 active

Reported	Class	Recall	Company	Reason	Where
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 Digi Eye (hypromellose recalledRohto Digi-eye	Rohto-Mentholatum (Vietnam)	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
4 Mar 2026Drug	CLASS II	Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution recalledVista Gonio Eye Lubricant	Wizcure Pharmaa Private	Sterility	Nationwide
4 Mar 2026Drug	CLASS II	Vista Gel Hypromellose USP 0.3% w/v recalled by Wizcure Pharmaa PrivateVista Hypromellose Dry Eye Relief	Wizcure Pharmaa Private	Sterility	Nationwide

All hypromellose recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
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 Digi Eye (hypromellose recalledRohto Digi-eye	Rohto-Mentholatum (Vietnam)	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
4 Mar 2026Drug	CLASS II	Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution recalledVista Gonio Eye Lubricant	Wizcure Pharmaa Private	Sterility	Nationwide
4 Mar 2026Drug	CLASS II	Vista Gel Hypromellose USP 0.3% w/v recalled by Wizcure Pharmaa PrivateVista Hypromellose Dry Eye Relief	Wizcure Pharmaa Private	Sterility	Nationwide

Should you stop taking Hypromellose?

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.