Chlorhexidine Gluconate recalls

The FDA has published 36 recalls involving Chlorhexidine Gluconate since 2016. The latest was reported on 22 Jul 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 recalls36since 2016
Last 12 months15reported
Class I1028% of total
Ongoing17latest 22 Jul 2026

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 10 28%Class II 23 64%Class III 3 8%

Why chlorhexidine gluconate is recalled

By year

Ongoing chlorhexidine gluconate recalls

17 active
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIBD ChloraPrep Clear, (2% w/v chlorhexidine gluconate recalledChloraprep One-stepCareFusion 213SterilityNationwide
DrugCLASS IIBD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) recalledChloraprep One-stepCareFusion 213SterilityNationwide
DrugCLASS IIBD ChloraPrep Hi-Lite Orange recalled by CareFusion 213Chloraprep One-stepCareFusion 213SterilityNationwide
DrugCLASS IIBD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate recalledChloraprep One-stepCareFusion 213SterilityNationwide
DrugCLASS IIBD ChloraPrep Hi-Lite Orange recalled by CareFusion 213Chloraprep One-stepCareFusion 213SterilityNationwide
DrugCLASS IIBD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate recalledChloraprep One-stepCareFusion 213SterilityNationwide

All chlorhexidine gluconate recalls, newest first

36 total

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.