Chlorhexidine Gluconate recalls

The FDA has published 35 recalls involving Chlorhexidine Gluconate since 2016. The latest was reported on 9 Sep 2026. Most were for sterility. CareFusion 213 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 recalls35since 2016

Last 12 months16reported

Class I926% of total

Ongoing18latest 9 Sep 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 1 0 1May 0 0 0Aug 0 0 0Nov 0 1 0Feb 0 0 0May 0 14 0Aug 1 0

Severity split

Class I 9 26%Class II 24 69%Class III 2 6%

Why chlorhexidine gluconate is recalled

Companies

CareFusion 2132674%
Professional Disposables International39%
Sage Products26%
Medline Industries13%
Xttrium Laboratories13%
Akorn13%
Ecolab13%

Brands

By year

20261646%
202526%
202313%
202239%
2021823%
202013%
201713%
201639%

Ongoing chlorhexidine gluconate recalls

18 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
22 Jul 2026Drug	CLASS II	BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate recalledChloraprep One-step	CareFusion 213	Sterility	Nationwide
8 Jul 2026Drug	CLASS II	BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) recalledChloraprep One-step	CareFusion 213	Sterility	Nationwide
8 Jul 2026Drug	CLASS II	BD ChloraPrep Hi-Lite Orange recalled by CareFusion 213Chloraprep One-step	CareFusion 213	Sterility	Nationwide
8 Jul 2026Drug	CLASS II	BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate recalledChloraprep One-step	CareFusion 213	Sterility	Nationwide
8 Jul 2026Drug	CLASS II	BD ChloraPrep Hi-Lite Orange recalled by CareFusion 213Chloraprep One-step	CareFusion 213	Sterility	Nationwide

All chlorhexidine gluconate recalls, newest first

35 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
22 Jul 2026Drug	CLASS II	BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate recalledChloraprep One-step	CareFusion 213	Sterility	Nationwide
8 Jul 2026Drug	CLASS II	BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) recalledChloraprep One-step	CareFusion 213	Sterility	Nationwide
8 Jul 2026Drug	CLASS II	BD ChloraPrep Hi-Lite Orange recalled by CareFusion 213Chloraprep One-step	CareFusion 213	Sterility	Nationwide
8 Jul 2026Drug	CLASS II	BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate recalledChloraprep One-step	CareFusion 213	Sterility	Nationwide
8 Jul 2026Drug	CLASS II	BD ChloraPrep Hi-Lite Orange recalled by CareFusion 213Chloraprep One-step	CareFusion 213	Sterility	Nationwide
8 Jul 2026Drug	CLASS II	BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate recalledChloraprep One-step	CareFusion 213	Sterility	Nationwide
8 Jul 2026Drug	CLASS II	BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate recalledChloraprep One-step	CareFusion 213	Sterility	Nationwide
8 Jul 2026Drug	CLASS II	BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate recalledChloraprep One-step	CareFusion 213	Sterility	Nationwide
8 Jul 2026Drug	CLASS II	ChloraPrep Frepp, Clear, (2% w/v chlorhexidine gluconate recalledChloraprep One-step	CareFusion 213	Sterility	Nationwide
8 Jul 2026Drug	CLASS II	BD ChloraPrep Hi-Lite Orange recalled by CareFusion 213Chloraprep One-step	CareFusion 213	Sterility	Nationwide
1 Jul 2026Drug	CLASS I	BD ChloraPrep Frepp Clear,(2% w/v chlorhexidine gluconate recalledChloraprep One-step	CareFusion 213	Sterility	Nationwide
1 Jul 2026Drug	CLASS I	BD ChloraPrep Clear (2% w/v chlorhexidine gluconate recalledChloraprep One-step	CareFusion 213	Sterility	Nationwide
1 Jul 2026Drug	CLASS II	BD ChloraPrep Frepp Clear, (2% w/v chlorhexidine gluconate recalledChloraprep One-step	CareFusion 213	Sterility	Nationwide
1 Jul 2026Drug	CLASS II	BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate recalledChloraprep One-step	CareFusion 213	Sterility	Nationwide
7 Jan 2026Drug	CLASS II	BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate recalledChloraprep Swabstick	CareFusion 213	Other	Nationwide
28 May 2025Drug	CLASS II	BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate recalledChloraprep One-step	CareFusion 213	Sterility	Nationwide
19 Mar 2025Drug	CLASS I	BD ChloraPrep Clear Applicators recalled by CareFusion 213Chloraprep One-step	CareFusion 213	Sterility	Nationwide
27 Sep 2023Drug	CLASS II	BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate recalledChloraprep One-step	CareFusion 213	Potency & Assay	Nationwide
2 Mar 2022Drug	CLASS II	Prevantics (chlorhexidine gluconate recalled by Professional DisposablesPrevantics Swabstick	Professional Disposables International	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022Drug	CLASS II	Prevantics (chlorhexidine gluconate recalled by Professional DisposablesPrevantics Maxi Swabstick	Professional Disposables International	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022Drug	CLASS II	Prevantics (chlorhexidine gluconate recalled by Professional DisposablesPrevantics Swab	Professional Disposables International	Manufacturing (CGMP) Deviations	Nationwide
16 Jun 2021Drug	CLASS III	Readyprep CHG, 2% Chlorhexidine Gluconate Cloth recalledReadyprep Chg	Medline Industries	Potency & Assay	Nationwide
19 May 2021Drug	CLASS I	BD ChloraPrep Hi-Lite Orange Applicator recalled by CareFusion 213Chloraprep One-step	CareFusion 213	Foreign Material	Nationwide
5 May 2021Drug	CLASS II	BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate recalledChloraprep One-step	CareFusion 213	Sterility	Nationwide
5 May 2021Drug	CLASS II	BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate recalledChloraprep One-step	CareFusion 213	Sterility	Nationwide
5 May 2021Drug	CLASS I	BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate recalledChloraprep One-step	CareFusion 213	Sterility	Nationwide
5 May 2021Drug	CLASS I	BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate recalledChloraprep One-step	CareFusion 213	Sterility	Nationwide
3 Mar 2021Drug	CLASS I	BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate recalledChloraprep One-step	CareFusion 213	Sterility	PR
3 Mar 2021Drug	CLASS I	BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate recalledChloraprep One-step	CareFusion 213	Sterility	PR

Should you stop taking Chlorhexidine Gluconate?

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.

Alert me about Chlorhexidine Gluconate

One email the day a new recall is posted for Chlorhexidine Gluconate. Unsubscribe any time.

At a glance

Latest recall: 9 Sep 2026
First on record: 16 Mar 2016
Class I share: 26%
Ongoing: 18

Drug classes

Injectable & IV Drugs 4,624Pain Medication 1,518Creams, Ointments & Gels 928Blood Pressure Medication 837Compounded Drugs 721Eye Drops 600Hormones & Birth Control 494Antibiotics 492Allergy Medication 348Stomach & Acid Reflux Medication 313Cold & Cough Medicine 312Thyroid Medication 242

Recall classes

CLASS ISerious harm or death possible.

CLASS IITemporary or reversible harm.

CLASS IIIUnlikely to cause harm.