Polyvinyl Alcohol recalls

The FDA has published 5 recalls involving Polyvinyl Alcohol since 2023. The latest was reported on 8 Apr 2026. Most were for sterility. Kilitch Healthcare India 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 2023

Last 12 months1reported

Class I240% of total

Ongoing5latest 8 Apr 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 1 0Feb 0 0 1May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 1 0May 0 0 0Aug 0 0

Severity split

Class I 2 40%Class II 2 40%Class III 1 20%

Why polyvinyl alcohol is recalled

Sterility480%
Packaging Defects120%

Companies

Brands

By year

2026120%
2025240%
2024120%
2023120%

Ongoing polyvinyl alcohol recalls

5 active

Reported	Class	Recall	Company	Reason	Where
8 Apr 2026Drug	CLASS II	Artificial Tears Sterile Lubricant Eye Drops recalledLeader Artificial Tears 15 Ml	K.C. Pharmaceuticals	Sterility	Nationwide
14 May 2025Drug	CLASS II	Polyvinyl Alcohol Ophthalmic Solution recalledPolyvinyl Alcohol	BRS Analytical Services	Sterility	Nationwide
8 Jan 2025Drug	CLASS III	Polyvinyl Alcohol Ophthalmic Solution recalled by AvKAREPolyvinyl Alcohol	AvKARE	Packaging Defects	Nationwide
14 Feb 2024Drug	CLASS I	Leader Eye Irritation Relief (Polyvinyl alcohol recalledEyes Irritation Relief	Kilitch Healthcare India	Sterility	Nationwide
29 Nov 2023Drug	CLASS I	Leader Eye Irritation Relief (Polyvinyl alcohol recalledEyes Irritation Relief	Cardinal Health	Sterility	Nationwide

All polyvinyl alcohol recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
8 Apr 2026Drug	CLASS II	Artificial Tears Sterile Lubricant Eye Drops recalledLeader Artificial Tears 15 Ml	K.C. Pharmaceuticals	Sterility	Nationwide
14 May 2025Drug	CLASS II	Polyvinyl Alcohol Ophthalmic Solution recalledPolyvinyl Alcohol	BRS Analytical Services	Sterility	Nationwide
8 Jan 2025Drug	CLASS III	Polyvinyl Alcohol Ophthalmic Solution recalled by AvKAREPolyvinyl Alcohol	AvKARE	Packaging Defects	Nationwide
14 Feb 2024Drug	CLASS I	Leader Eye Irritation Relief (Polyvinyl alcohol recalledEyes Irritation Relief	Kilitch Healthcare India	Sterility	Nationwide
29 Nov 2023Drug	CLASS I	Leader Eye Irritation Relief (Polyvinyl alcohol recalledEyes Irritation Relief	Cardinal Health	Sterility	Nationwide

Should you stop taking Polyvinyl Alcohol?

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.