Artificial Tears recalls

The FDA has published 6 recalls involving Artificial Tears since 2021. The latest was reported on 14 May 2025. Most were for sterility. Akorn 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 2021

Last 12 months0reported

Class I00% of total

Ongoing5latest 14 May 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 1 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

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

Why artificial tears is recalled

Sterility583%
Potency & Assay117%

Companies

Akorn583%
BRS Analytical Services117%

By year

2025117%
2023467%
2021117%

Ongoing artificial tears recalls

5 active

Reported	Class	Recall	Company	Reason	Where
14 May 2025Drug	CLASS II	Artificial Tears Ophthalmic Solution recalled by BRS Analytical ServicesArtificial Tears	BRS Analytical Services	Sterility	Nationwide
7 Jun 2023Drug	CLASS II	Artificial Tears Solution, Polyvinyl Alcohol recalled by Akorn	Akorn	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	Artificial Tears Ointment, Sterile, For Ophthalmic Use Only tubes recalled	Akorn	Sterility	Nationwide
25 Jan 2023Drug	CLASS II	Artificial Tears Solution, Lubricant Eye Drops recalled by Akorn	Akorn	Sterility	Nationwide
25 Jan 2023Drug	CLASS II	Artificial Tears Ointment, Lubricant Eye Ointment recalled by Akorn	Akorn	Sterility	Nationwide

All artificial tears recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
14 May 2025Drug	CLASS II	Artificial Tears Ophthalmic Solution recalled by BRS Analytical ServicesArtificial Tears	BRS Analytical Services	Sterility	Nationwide
7 Jun 2023Drug	CLASS II	Artificial Tears Solution, Polyvinyl Alcohol recalled by Akorn	Akorn	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	Artificial Tears Ointment, Sterile, For Ophthalmic Use Only tubes recalled	Akorn	Sterility	Nationwide
25 Jan 2023Drug	CLASS II	Artificial Tears Solution, Lubricant Eye Drops recalled by Akorn	Akorn	Sterility	Nationwide
25 Jan 2023Drug	CLASS II	Artificial Tears Ointment, Lubricant Eye Ointment recalled by Akorn	Akorn	Sterility	Nationwide
8 Sep 2021Drug	CLASS II	Artificial Tears Ointment, Lubricant Eye Ointment recalled by Akorn	Akorn	Sterility	Nationwide

Should you stop taking Artificial Tears?

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.