Chlorhexidine Gluconate recalls

Chlorhexidine Gluconate products have been recalled 3 times, most recently on 9 Sep 2026. The recalling company is usually Sage Products. The most common reason is manufacturing (cgmp) deviations.

Total recalls3since 2016

Last 12 months1reported

Class I00% of total

Ongoing1latest 9 Sep 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 0 0 0May 0 0 0Aug 1 0

Severity split

Class I 0 0%Class II 3 100%Class III 0 0%

Why chlorhexidine gluconate is recalled

Manufacturing (CGMP) Deviations267%
Other Reasons133%

Companies

Sage Products267%
Xttrium Laboratories133%

By year

2026133%
2017133%
2016133%

Ongoing chlorhexidine gluconate recalls

1 active

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS II	2% Chlorhexidine Gluconate* Cloth, Non-sterile recalled by Sage ProductsChlorhexidine Gluconate	Sage Products	Other	Nationwide

All chlorhexidine gluconate recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS II	2% Chlorhexidine Gluconate* Cloth, Non-sterile recalled by Sage ProductsChlorhexidine Gluconate	Sage Products	Other	Nationwide
12 Jul 2017Drug	CLASS II	Chlorhexidine Gluconate 0.12% Oral Rinse, USP, 1 Pint recalledChlorhexidine Gluconate	Xttrium Laboratories	Manufacturing (CGMP) Deviations	IL
28 Dec 2016Drug	CLASS II	2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package recalledChlorhexidine Gluconate	Sage Products	Manufacturing (CGMP) Deviations	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.